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Gazyva/Gazyvaro versus mycophenolate mofetil shows significantly more children and young adults achieved sustained complete remission at week 52
If approved, Gazyva/Gazyvaro could help children and young adults sustain remission, potentially with a reduced need for steroids to manage their disease¹
INShore is the first global phase III study of a targeted therapy in this chronic kidney disease commonly diagnosed in early childhood

Basel, 28 October 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today statistically significant and clinically meaningful results from the phase III INShore study of Gazyva®/Gazyvaro® (obinutuzumab) in children and young adults (aged >= 2-25 years) with idiopathic nephrotic syndrome (INS). The study met its primary endpoint, with more people achieving sustained complete remission at one year (week 52) with Gazyva/Gazyvaro compared with mycophenolate mofetil (MMF). Sustained complete remission was defined by the absence of relapses during the study together with a low amount of protein in the urine (protein to creatine of 0.2 or less) at week 52.¹ Certain important key secondary endpoints were also met. No new safety signals were identified and safety was in line with the well-characterised profile of Gazyva/Gazyvaro in adults.

“These results show that Gazyva/Gazyvaro may achieve robust disease control with a reduced need for corticosteroids, which are associated with serious side effects over time,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “Idiopathic nephrotic syndrome is a severe and chronic kidney disease usually diagnosed in early childhood, yet meaningful treatment progress has been limited. As a targeted therapy, Gazyva/Gazyvaro has the potential to help address this unmet need and we look forward to sharing the data with health authorities.”

For several decades, treatment for idiopathic nephrotic syndrome has primarily relied on steroids yet relapse rates remain high and long-term use is limited by serious side effects.^2-4 Newer approaches that target specific immune cells - such as B cells, thought to be a key driver of disease activity - may help control symptoms more effectively.^5,6

Analysis of key secondary endpoints showed statistically significant and clinically meaningful benefits with Gazyva/Gazyvaro with an increase in those with overall relapse-free survival (RFS), median time to relapse or death, reduction in cumulative corticosteroid dose from baseline to week 52, and fewer relapses from baseline to week 52, all compared with MMF. Other key secondary endpoints showed no significant difference with Gazyva/Gazyvaro versus MMF.*

Data will be presented at an upcoming medical meeting and shared with health authorities, including the US Food and Drug Administration and the European Medicines Agency.

INShore data add to a growing body of evidence, including the phase III REGENCY study in lupus nephritis, that shows targeting disease-causing B cells with Gazyva/Gazyvaro may help address disease activity across a spectrum of immune-mediated kidney and kidney-related diseases.^7-10 In October 2025, Gazyva/Gazyvaro was approved in the US for the treatment of adults with active lupus nephritis who are receiving standard therapy, based on data from the phase III REGENCY and phase II NOBILITY studies.

In addition to idiopathic nephrotic syndrome, Gazyva/Gazyvaro is being investigated in membranous nephropathy, lupus nephritis, rare immune-mediated kidney diseases and systemic lupus erythematosus an autoimmune disease that can lead to lupus nephritis, as part of our ambition to be leaders in immune-mediated kidney and kidney-related diseases.^11-13

About Gazyva/Gazyvaro
Gazyva®/Gazyvaro® (obinutuzumab) is a Type II engineered humanised monoclonal antibody designed to attach to CD20, a protein found on certain types of B cells.¹⁴

Gazyva/Gazyvaro is approved for adults with lupus nephritis who are receiving standard therapy in the US. In October 2025, the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended approval in the European Union, with a final decision expected from the European Commission in the near future. Gazyva/Gazyvaro is also approved in 100 countries for various types of haematological cancers.

In the US, Gazyva is part of a collaboration between Genentech and Biogen.

About the INShore study
INShore [NCT05627557] is a phase III open-label, randomised, multicentre study investigating Gazyva®/Gazyvaro® (obinutuzumab) compared with mycophenolate mofetil (MMF) in children and young adults in clinical remission (aged >=2-25 years) with frequently relapsing or steroid-dependent nephrotic syndrome. The study enrolled 85 children or young adults who were randomised 1:1 to receive Gazyva/Gazyvaro at weeks 0,2, 24 and 26, or MMF daily. The primary endpoint is the percentage of participants with sustained complete remission at one year (week 52).

About idiopathic nephrotic syndrome
Idiopathic nephrotic syndrome is a rare kidney-related autoimmune disease, usually diagnosed in early childhood.² It is characterised by unpredictable relapses that cause fatigue, swelling, weight gain and increased susceptibility to infections and clotting, as well as anxiety, depression and reduced self-esteem, brought on by the fear of relapse and social isolation.^2,15 The current mainstay of treatment is steroids, however relapse rates remain high (>70%) and the serious side effects limit long-term use.^2-4

There is an urgent need for new targeted treatment approaches that can sustain remission and reduce the physical and psychosocial burden of the disease.

About Roche in kidney and kidney-related diseases
For more than 20 years, we have combined innovation, scientific expertise and commitment to patients to address unmet needs in kidney diseases. Today, our industry-leading programme includes Gazyva®/Gazyvaro® (obinutuzumab), approved in the US for adults with lupus nephritis, and more than 10 phase II-III clinical studies in immune-mediated kidney and kidney-related diseases with some of the highest unmet needs.

Our aim is to continue delivering meaningful value for those affected, healthcare systems and society, and help address this growing public health burden.

About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.

For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045.

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

*Sustained complete remission (week 76), probability of relapse free survival (week 52), proportion of participants experiencing oedema associated relapse (during 52 week treatment period), mean change in CureGN Edema scale (from baseline to week 52), mean change in “General Fatigue” domain of PedsQL-Multidimensional Fatigue Scale total score (from baseline to week 52), mean change in “Physical Functioning” domain of PedsQL (from baseline to week 52).

References
[1] Clinicaltrials.gov. A Study to Evaluate the Efficacy and Safety of Obinutuzumab Versus MMF in Participants With Childhood Onset Idiopathic Nephrotic Syndrome (INShore). [Internet; cited 2025 October 27]. Available from: https://clinicaltrials.gov/study/NCT05627557?term=inshore&rank=1
[2] Vivarelli M, et al. Childhood nephrotic syndrome. Lancet. 2023 Sep 2;402(10404):809-24.
[3] Noone DG, et al. Idiopathic nephrotic syndrome in children. Lancet. 2018 Jul 7;392(10141):61-74.
[4] Canetta PAA ,et al. The Evidence-Based Approach to Adult-Onset Idiopathic Nephrotic Syndrome. Front Pediatr. 2015 Sep 25:3:78.
[5] Colucci M, et al. B-Cell Dysregulation in Idiopathic Nephrotic Syndrome: What We Know and What We Need to Discover. Front Immunol. 2022 Jan 24;13:823204.
[6] Al-Aubodah TA, et al. The extrafollicular B cell response is a hallmark of childhood idiopathic nephrotic syndrome. Nat Commun. 2023 Nov 24;14(1):7682.
[7] Furie RA, et al. B-cell depletion with obinutuzumab for the treatment of proliferative lupus nephritis: a randomised, double-blind, placebo-controlled trial. Ann Rheum Dis. 2022 Jan;81(1):100-07.
[8] Furie RA, et al. Efficacy and safety of obinutuzumab in active lupus nephritis. N Engl J Med. 2025 Feb;392:1471-83.
[9] Arnold J, et al. Efficacy and safety of obinutuzumab in systemic lupus erythematosus patients with secondary non-response to rituximab. Rheumatology (Oxford). 2022 Nov 28;61(12):4905-09.
[10] Cheng X, et al. Efficacy and safety of obinutuzumab in primary membranous nephropathy: a real-world retrospective study. Front Immunol. 2025 Aug 21;16:1650054.
[11] Clinicaltrials.gov. A study evaluating the efficacy and safety of obinutuzumab in participants with primary membranous nephropathy (MAJESTY). [Internet; cited 2025 October 27]. Available from: https://clinicaltrials.gov/study/NCT04629248
[12] Clinicaltrials.gov. A Study To Evaluate The Efficacy And Safety Of Obinutuzumab In Patients With ISN/RPS 2003 Class III Or IV Lupus Nephritis (REGENCY). [Internet; cited 2025 October 22]. Available from: https://clinicaltrials.gov/study/NCT04221477
[13 Clinicaltrials.gov. A study to evaluate the efficacy and safety of obinutuzumab in participants with systemic lupus erythematosus (ALLEGORY). [Internet; cited 2025 October 27]. Available from: https://clinicaltrials.gov/study/NCT04963296.
[14] Herter S, et al. Preclinical activity of the type II CD20 antibody GA101 (obinutuzumab) compared with rituximab and ofatumumab in vitro and in xenograft models. Mol Cancer Ther. 2013 Oct;12(10):2031-42.
[15] Shukla J, et al. Quality of Life of Children with Idiopathic Nephrotic Syndrome. Indian J Nephrol. 2025 Feb 25;35(2):234–42

Roche Global Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

Hans Trees, PhD Phone: +41 79 407 72 58	Sileia Urech Phone: +41 79 935 81 48
Nathalie Altermatt Phone: +41 79 771 05 25	Lorena Corfas Phone: +41 79 568 24 95
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Media Release Gazyva INShore study English

Gazyva/Gazyvaro versus mycophenolate mofetil shows significantly more children and young adults achieved sustained complete remission at week 52
If approved, Gazyva/Gazyvaro could help children and young adults sustain remission, potentially with a reduced need for steroids to manage their disease¹
INShore is the first global phase III study of a targeted therapy in this chronic kidney disease commonly diagnosed in early childhood

Data will be presented at an upcoming medical meeting and shared with health authorities, including the US Food and Drug Administration and the European Medicines Agency.

About Gazyva/Gazyvaro
Gazyva®/Gazyvaro® (obinutuzumab) is a Type II engineered humanised monoclonal antibody designed to attach to CD20, a protein found on certain types of B cells.¹⁴

In the US, Gazyva is part of a collaboration between Genentech and Biogen.

There is an urgent need for new targeted treatment approaches that can sustain remission and reduce the physical and psychosocial burden of the disease.

Our aim is to continue delivering meaningful value for those affected, healthcare systems and society, and help address this growing public health burden.

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

For more information, please visit www.roche.com.

Roche Global Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

Hans Trees, PhD Phone: +41 79 407 72 58	Sileia Urech Phone: +41 79 935 81 48
Nathalie Altermatt Phone: +41 79 771 05 25	Lorena Corfas Phone: +41 79 568 24 95
Simon Goldsborough Phone: +44 797 32 72 915	Karsten Kleine Phone: +41 79 461 86 83
Kirti Pandey Phone: +49 172 6367262	Yvette Petillon Phone: +41 79 961 92 50
Dr Rebekka Schnell Phone: +41 79 205 27 03

All rights reserved ©2025 F. Hoffmann-La Roche Ltd.
Group Communications, Grenzacherstrasse 124, CH-4070 Basel, Switzerland

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Basel, 23 October 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that Nina Schwab-Hautzinger (1975) has been appointed Head of Group Communications and a member of the enlarged Corporate Executive Committee effective 1 February 2026.

Nina Schwab-Hautzinger rejoins Roche from her role at BASF as Head of Corporate Communications and Government Relations. During her previous thirteen year tenure at Roche, Nina Schwab-Hautzinger held various communications leadership roles such as Head of Corporate Brand & Communications at the Group level and Head of Communications & Public Affairs for Pharma in Germany. She has also led the healthcare practice in a strategic communications consultancy in Singapore.

Nina Schwab-Hautzinger studied at the University of Mannheim, Germany and the University of Waterloo, Canada. She received her doctorate from the University of Zurich, Switzerland, Department of Communication and Media Research.

Roche’s CEO Thomas Schinecker: “I am pleased to announce that Nina Schwab-Hautzinger will be returning to Roche as Head of Group Communications and will join Roche’s executive leadership team. In today’s rapidly evolving world, clear and impactful communication is a critical success factor both internally and externally for any company. Nina’s extensive expertise, expansive network, and her experience across global, regional, and local contexts will be instrumental in advancing our long-term strategic ambitions. I would like to thank the current Head of Group Communications, Barbara Schaedler, for staying on longer to ensure a smooth hand-over."

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

Roche Global Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

Hans Trees, PhD Phone: +41 79 407 72 58	Sileia Urech Phone: +41 79 935 81 48
Nathalie Altermatt Phone: +41 79 771 05 25	Lorena Corfas Phone: +41 79 568 24 95
Simon Goldsborough Phone: +44 797 32 72 915	Karsten Kleine Phone: +41 79 461 86 83
Kirti Pandey Phone: +49 172 6367262	Yvette Petillon Phone: +41 79 961 92 50
Dr Rebekka Schnell Phone: +41 79 205 27 03

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Media Release Changes to Enlarged CEC English

All rights reserved ©2025 F. Hoffmann-La Roche Ltd.
Group Communications, Grenzacherstrasse 124, CH-4070 Basel, Switzerland

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Basel, 23 October 2025

Group sales grew by 7%¹ at constant exchange rates (CER; 2% in CHF) in the first nine months, driven by high demand for our innovative medicines and diagnostics.
Pharmaceuticals Division sales rose by 9% (4% in CHF) due to continued high growth in sales of medicines for the treatment of severe diseases; Phesgo (breast cancer), Xolair (food allergies), Hemlibra (haemophilia A), Vabysmo (serious eye diseases) and Ocrevus (multiple sclerosis) were the top growth drivers.
Diagnostics Division sales increased by 1% (-4% in CHF) as demand for pathology solutions and molecular diagnostics more than offset the impact of healthcare pricing reforms in China.
Highlights:
- US approval for Tecentriq combination for a form of lung cancer and Gazyva/Gazyvaro for a severe kidney disease
- EU CE mark for Contivue, a port delivery platform with Susvimo*, for a severe eye disease
- Positive EU CHMP recommendation for the subcutaneous formulation of Lunsumio for a type of blood cancer and for Gazyva/Gazyvaro for a severe kidney disease
- Positive data from phase III study on giredestrant in breast cancer, phase II open-label extension study on fenebrutinib in multiple sclerosis, phase I/II study on trontinemab in Alzheimer’s disease and long-term follow-up studies on Vabysmo and Susvimo in a severe age-related eye disease
- Advancement of several key drug candidates into phase III trials: zilebesiran for uncontrolled hypertension, CT-388 for obesity, CT-868 for type 1 diabetes, cevostamab for a difficult-to-treat form of blood cancer and ZN-1041 for a type of breast cancer
- Announcement of a merger agreement to acquire 89bio and its phase III FGF21 analogue for the treatment of moderate to severe metabolic dysfunction-associated steatohepatitis (MASH), a form of fatty liver disease that is one of the most prevalent comorbidities of obesity
- EU CE mark and US approval for the Elecsys pTau181, the only FDA-cleared blood test for use in primary care to rule out Alzheimer’s disease-related amyloid pathology
- EU CE mark for the first AI-based risk stratification tool to assess progressive decline in kidney function and for the sixth-generation Troponin T test, which shows a new level of accuracy critical in diagnosing heart attacks
Outlook for 2025 earnings raised.

Roche CEO Thomas Schinecker: “We continue to build on our positive momentum with strong sales growth of 7% at constant exchange rates.

Our momentum is further reflected in our pipeline with a number of positive clinical read-outs and a record ten potentially transformative medicines progressing into the final phase of development for diseases with significant unmet need. By the end of the decade, we expect phase III clinical results for up to 19 new medicines.

Our groundbreaking next-generation sequencing technology, set to launch next year, has achieved a new record for decoding a whole human genome in under four hours.

Based on our strong results, we are raising our earnings outlook for the full year.”

Sales	CHF millions		As % of sales		% change
January–September	2025	2024	2025	2024	At CER	In CHF
Group	45,862	44,984	100.0	100.0	7	2

Pharmaceuticals Division	35,555	34,257	77.5	76.2	9	4
United States	18,798	18,166	41.0	40.4	8	3
Europe	6,818	6,613	14.9	14.7	5	3
Japan	2,139	2,083	4.7	4.6	5	3
International**	7,800	7,395	16.9	16.5	13	5

Diagnostics Division	10,307	10,727	22.5	23.8	1	-4

**Asia-Pacific, CEETRIS (Central Eastern Europe, Türkiye, Russia and Indian subcontinent), Latin America, Middle East, Africa, Canada, others

Outlook for 2025 earnings raised
Roche (SIX: RO, ROG; OTCQX: RHHBY) expects an increase in Group sales in the mid single digit range (CER). Core earnings per share are targeted to develop in the high single to low double digit range (CER). Roche expects to further increase its dividend in Swiss francs.

Group sales
In the first nine months of 2025, Roche achieved sales growth of 7% (2% in CHF) to CHF 45.9 billion due to strong demand for our pharmaceutical and diagnostic products.

The appreciation of the Swiss franc against most currencies, notably the US dollar, had an adverse impact on sales when reported in Swiss francs compared to constant exchange rates.

Sales in the Pharmaceuticals Division increased by 9% (4% in CHF) to CHF 35.6 billion, with medicines for severe diseases continuing their strong growth.

The top five growth drivers – Phesgo, Xolair, Hemlibra, Vabysmo and Ocrevus – achieved total sales of CHF 15.8 billion. This represents an increase of CHF 2.4 billion at CER compared to the first nine months of 2024.

This increase more than compensated for the total decrease of CHF 0.5 billion (CER) in sales of the ‘loss of exclusivity (LOE)’ products – the decline in sales of Avastin (various types of cancer), Herceptin (breast and gastric cancer), MabThera/Rituxan (blood cancer, rheumatoid arthritis), Lucentis (severe eye diseases) and Esbriet (lung disease) was partially offset by an increase in sales of Actemra/RoActemra (rheumatoid arthritis).

In the United States, sales rose by 8% due to growth in sales of Xolair, Phesgo, Ocrevus, Hemlibra, Polivy (blood cancer) and Vabysmo. This growth more than compensated for the decline in sales of medicines with expired patents.

Sales in Europe grew 5% as strong demand for Ocrevus and Vabysmo and the continuing uptake of Polivy, Phesgo and Hemlibra more than compensated for the lower sales of Perjeta (breast cancer) due to ongoing conversion of patients to Phesgo and the impact of biosimilar competition on Actemra/RoActemra sales.

In Japan, sales increased by 5%, mainly due to the strong uptake of Phesgo, Hemlibra, Vabysmo and PiaSky (paroxysmal nocturnal haemoglobinuria). Sales growth was partially offset by the decline in sales of Perjeta due to continued conversion of patients to Phesgo and of Avastin because of biosimilar erosion.

Sales in the International region grew by 13%, led by Phesgo, Hemlibra, Vabysmo, Xofluza (influenza) and Kadcyla (breast cancer). In China, sales rose by 9%, driven by the uptake of Phesgo due to inclusion in the government drug reimbursement list, strong sales of Xofluza and the continued roll-out of Polivy and Vabysmo.

The Diagnostics Division’s sales increased by 1% (-4% in CHF) to CHF 10.3 billion as growth in demand for pathology solutions and molecular diagnostics more than offset the impact of healthcare pricing reforms in China.

Sales in the Europe, Middle East and Africa (EMEA) region increased by 6%, driven by higher sales of clinical chemistry and immunodiagnostic products. In North America, sales increased by 7%, with growth across customer areas. Sales in Asia-Pacific decreased by 15% due to healthcare pricing reforms in China. Latin America sales grew by 14%.

Pharmaceuticals: key developments

Compound	Milestone
Regulatory
Gazyva/ GazyvaroBlood cancer	FDA approves Roche’s Gazyva/Gazyvaro for the treatment of lupus nephritisThe FDA approval is based on the superiority of Gazyva/Gazyvaro over standard therapy alone, as shown by the phase II NOBILITY and phase III REGENCY dataGazyva/Gazyvaro is the only anti-CD20 monoclonal antibody to demonstrate a complete renal response benefit in lupus nephritis in a randomised phase III studyLupus nephritis affects more than 1.7 million people worldwide, predominantly women of colour and childbearing age, with up to one-third of patients progressing to end-stage kidney disease More information: Media Release, 20 October 2025
Gazyva/ GazyvaroBlood cancer	CHMP recommends EU approval of Roche’s Gazyva/Gazyvaro for lupus nephritisThe positive recommendation is based on phase II NOBILITY and phase III REGENCY data showing the superiority of Gazyva/Gazyvaro over standard therapy aloneGazyva/Gazyvaro is the only anti-CD20 antibody to demonstrate a complete renal response benefit in lupus nephritis in a randomised phase III studyLupus nephritis is a debilitating condition that severely impacts a person’s quality of life and affects more than 1.7 million people worldwide More information: Media Release, 17 October 2025
TecentriqLung cancer	FDA approves Tecentriq plus lurbinectedin as first-line maintenance therapy for extensive-stage small cell lung cancer (ES-SCLC)The combination reduced the risk of disease progression or death by 46% and risk of death by 27% in pivotal phase III IMforte studyThis is the first and only combination therapy for the first-line maintenance treatment of ES-SCLC, which is critical to help address the high rate of relapse in ES-SCLCThe regimen is recommended in the National Comprehensive Cancer Network Guidelines for SCLCMore information: Media Release, 3 October 2025
LunsumioBlood cancer	CHMP recommends EU approval of subcutaneous formulation of Lunsumio for people with relapsed or refractory follicular lymphomaLunsumio provides high and long-lasting response rates, with approximately two-thirds of patients with a complete response in remission after four yearsSubcutaneous Lunsumio has the potential to substantially reduce treatment administration time with an injection of approximately one minute, compared with an IV infusion of two to four hoursIf approved, Lunsumio would be the first treatment available for people with follicular lymphoma after two or more lines of systemic therapy, which is both fixed-duration and subcutaneously administeredMore information: Media Release, 19 September 2025
SusvimoSevere eye diseases	Roche receives CE mark for Contivue, its port delivery platform with Susvimo, for neovascular or ‘wet’ age-related macular degeneration (nAMD)Susvimo is under review with the EMA and once approved, will be the first continuous delivery treatment for nAMD, affecting 1.7 million in the European UnionNew seven-year data from the LADDER study show Contivue with Susvimo provides good visual outcomes with stable retinal anatomy over the longer termWith up to two refills per year, Contivue with Susvimo provides reliable, long-term vision outcomes and is approved in the US for nAMD, diabetic macular edema (DME) and diabetic retinopathy (DR)More information: Media Release, 4 September 2025
ElevidysDuchenne muscular dystrophy	Regulatory update on Elevidys gene therapy for Duchenne muscular dystrophy (DMD) in the EUEMA’s CHMP issued an opinion not to recommend Elevidys for the treatment of ambulatory individuals with DMDRoche will continue its dialogue with the EMA to explore a potential path forward to make Elevidys available to individuals living with DMD in the EURoche believes the benefit-risk remains positive in the ambulatory DMD populationElevidys is the first and only disease-modifying gene therapy for DMD More information: Media Release, 25 July 2025
Phase III, pivotal and other key read-outs
TecentriqBladder cancer	Tecentriq showed significant overall and disease-free survival benefits in bladder cancer with ctDNA-guided treatmentTecentriq reduced the risk of death by 41% and the risk of disease recurrence or death by 36% compared with placeboIMvigor011 is the first global phase III study to read out a pioneering ctDNA-guided approach to post-surgery treatment in muscle-invasive bladder cancerData was presented as part of the Presidential Symposium at the European Society for Medical Oncology (ESMO) Congress 2025More information: Media Release, 20 October 2025
GiredestrantBreast cancer	Phase III evERA data showed that giredestrant significantly improved progression-free survival in people with ER-positive advanced breast cancerGiredestrant plus everolimus reduced the risk of disease progression or death by 44% and 62% in the intent-to-treat (ITT) and ESR1-mutated populations, respectively, in a post-CDK inhibitor setting, compared with standard-of-care endocrine therapy plus everolimusThe giredestrant combination was well tolerated; no new safety signals were observed including no photopsiaIf approved, giredestrant plus everolimus could be the first and only oral selective oestrogen receptor degrader combination in the post-CDK inhibitor settingMore information: Media Release, 18 October 2025
VamikibartSevere eye disease	Roche presents new phase III pivotal data for vamikibart in uveiticmacular edema (UME), a serious cause of vision lossVamikibart is the first non-steroid targeted therapy designed to address inflammation driving UME and may offer a potential new treatment option for patientsVision improvements were seen in both pivotal studies, achieving statistical significance in MEERKAT and nominal significance in SANDCATThe MEERKAT and SANDCAT trials are ongoing and the data will be discussed with health authorities globallyMore information: Media Release, 17 October 2025
Ocrevus/ FenebrutinibMultiple sclerosis	Roche presents new data for Ocrevus and fenebrutinib across broad patient populations at the 2025 Conference of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS)Ocrevus subcutaneous maintains a consistent benefit-risk profile after two yearsNew late-breaking data confirm that Ocrevus significantly reduces disability progression in adults with advanced primary progressive multiple sclerosis (PPMS)One-year data reinforce that the majority of infants potentially exposed to Ocrevus during pregnancy or breastfeeding exhibit antibody responsesFenebrutinib two-year phase II data demonstrate near-complete suppression of disease activity at 96 weeksMore information: Media Release, 24 September 2025
GiredestrantBreast cancer	Positive phase III results show giredestrant significantly improved progression-free survival in ER-positive advanced breast cancerevERA met its co-primary endpoints; giredestrant plus everolimus demonstrated significant benefit in intent-to-treat (ITT) and ESR1-mutated populations in the post-CDK inhibitor setting, compared with standard of care plus everolimusThe all-oral combination was well tolerated and adverse events were consistent with the known safety profiles of the individual study treatments; no new safety signals were observedevERA is the first positive head-to-head phase III trial investigating an all-oral selective oestrogen receptor degrader-containing regimen versus a standard of care combinationMore information: Media Release, 22 September 2025
VabysmoSevere eye diseases	New data for Vabysmo reinforce its efficacy, safety and durability in neovascular or ‘wet’ age-related macular degeneration (nAMD)In AVONELLE-X, the largest long-term extension trial in nAMD, disease control and durability were maintained over four years, with nearly 80% of patients on extended dosing by study endOver 60% of people with a difficult-to-tre

Tecentriq reduced the risk of death by 41% and the risk of disease recurrence or death by 36% compared with placebo¹
IMvigor011 is the first global phase III study to read out pioneering a ctDNA- guided approach to post-surgery treatment in muscle-invasive bladder cancer
Data being presented as part of the Presidential Symposium at the ESMO Congress 2025

Basel, 20 October 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today positive results from the phase III IMvigor011 study evaluating Tecentriq® (atezolizumab) as an adjuvant treatment for people with muscle-invasive bladder cancer (MIBC) who are at risk of recurrence after surgery (cystectomy) and have detectable circulating tumour DNA (ctDNA). In this ctDNA-guided setting, Tecentriq reduced the risk of death (overall survival, OS) by 41% and the risk of disease recurrence or death (disease-free survival, DFS) by 36%, both compared with placebo. This ctDNA-guided approach, using Natera’s Signatera^TM ctDNA Molecular Residual Disease (MRD) test, spared people at low risk of recurrence from unnecessary treatment and side effects. The safety profile was consistent with previous studies of Tecentriq.¹

These results are being presented as part of the Presidential Symposium at the European Society for Medical Oncology (ESMO) Congress 2025. They will also be discussed with health authorities, including the U.S. Food and Drug Administration (FDA).

“These clinically meaningful results show that Tecentriq helped people with muscle-invasive bladder cancer live longer and without their disease returning,” said Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development. “The use of serial ctDNA testing to detect molecular residual disease may also advance bladder cancer treatment by combining a precision diagnostic with cancer immunotherapy.”

“Even after surgery, most people with muscle-invasive bladder cancer will face the physical and emotional toll of further treatment,” said Professor Thomas Powles, lead principal investigator of IMvigor011, Professor of Genitourinary Oncology; Chair of Barts Cancer Centre at St. Bartholomew's Hospital. “These results indicate that with Signatera ctDNA testing, we may be able to identify those at risk of recurrence who could benefit from adjuvant atezolizumab treatment and spare others from unnecessary therapy, paving the way for a more personalised treatment approach.”

At median follow up of 16.1 months, median DFS was 9.9 months in the Tecentriq arm versus 4.8 months in the placebo arm (stratified hazard ratio [HR]=0.64; 95% CI: 0.47-0.87, p =0.0047). Median OS was 32.8 months in the Tecentriq arm versus 21.1 months in the placebo arm (HR=0.59; 95% CI: 0.39-0.90, p=0.0131). People who persistently tested for no detectable ctDNA had low risk of recurrence.¹

More than 150,000 people worldwide are diagnosed with MIBC each year.^2,3 It is an aggressive type of cancer, with poor long-term outcomes and high treatment burden.⁴Despite this, personalised treatment approaches lag behind other cancer types.⁵ ctDNA-guided treatment could change this, by helping healthcare professionals tailor treatment more precisely to improve clinical benefit and reduce unnecessary intervention.¹

About the IMvigor011 study
IMvigor011 [NCT04660344] is a global phase III, randomised, placebo-controlled, double-blind study designed to evaluate the efficacy and safety of adjuvant treatment with Tecentriq® (atezolizumab) compared with placebo in participants with muscle-invasive bladder cancer (MIBC) who are circulating tumour DNA (ctDNA)-positive and are at risk of recurrence following cystectomy. IMvigor011 utilised Natera’s Signatera^TM as the clinical trial assay. This personalised ctDNA test for the detection of MRD is currently under review by the FDA for use as a companion diagnostic. 761 people participated in the surveillance phase of IMvigor011 and those with positive Signatera tests (250 people) joined the treatment phase, where they received either Tecentriq or placebo. The primary endpoint is investigator-assessed disease-free survival (DFS). Secondary endpoints include overall survival (OS) and tolerability, amongst others.

About Tecentriq® (atezolizumab)

Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1, which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the re-activation of T cells. Tecentriq may also affect normal cells.

Tecentriq has been approved for some of the most aggressive and difficult-to-treat forms of cancer and is the first PD-(L)1 cancer immunotherapy available in both subcutaneous and intravenous formulations. Tecentriq was the first cancer immunotherapy approved for the treatment of a certain type of early-stage (adjuvant) non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC) and hepatocellular carcinoma (HCC). Tecentriq is also approved in countries around the world, either alone or in combination with targeted therapies and/or chemotherapies, for various forms of metastatic NSCLC, certain types of metastatic urothelial cancer (mUC), PD-L1-positive metastatic triple-negative breast cancer (TNBC), BRAF V600 mutation-positive advanced melanoma and alveolar soft part sarcoma (ASPS).

About Roche in cancer immunotherapy
To learn more about Roche’s scientific-led approach to cancer immunotherapy, please follow this link: https://www.roche.com/solutions/focus-areas/oncology/cancer-immunotherapy

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

References
[1] Powles T, et al. IMvigor011: a Phase 3 trial of circulating tumour (ct)DNA-guided adjuvant atezolizumab vs placebo in muscle-invasive bladder cancer. To be presented at: ESMO Congress; 2025 Oct 17-21; Berlin, Germany. Abstract #LBA8.

[2] Global Cancer Observatory. Cancer Today GLOBOCAN 2022 Factsheet – Bladder [Internet; cited 2025 October]. Available from: https://gco.iarc.who.int/media/globocan/factsheets/cancers/30-bladder-fact-sheet.pdf.

[3] Ghandour R, et al. Treatment Options and Outcomes in Nonmetastatic Muscle Invasive Bladder Cancer. Trends Cancer. 2019;5(7):426-39.

[4] Vogl U, et al. Current advances in the perioperative treatment of muscle-invasive bladder cancer. Healthbook TIMES Oncol. Hematol. 2025;24(2):54-63.

[5] Van Hoogstraten LMC, et al. Global trends in the epidemiology of bladder cancer challenges for public health and clinical practice. Nat Rev Clin Oncol. 2023;20:287-304.

Roche Global Media Relations
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Hans Trees, PhD Phone: +41 79 407 72 58	Sileia Urech Phone: +41 79 935 81 48
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Roche Investor Relations

Dr. Bruno Eschli Phone: +41 61 68-75284 e-mail: bruno.eschli@roche.com	Dr. Sabine Borngräber Phone: +41 61 68-88027 e-mail: sabine.borngraeber@roche.com
Dr. Birgit Masjost Phone: +41 61 68-84814 e-mail: birgit.masjost@roche.com

Investor Relations North America

Loren Kalm
Phone: +1 650 225 3217
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Attachment

Media & Investor Release IMvigor011 ESMO

FDA approval based on superiority of Gazyva/Gazyvaro over standard therapy alone, as shown in phase II NOBILITY and phase III REGENCY data^1,2
Gazyva/Gazyvaro is the only anti-CD20 monoclonal antibody to demonstrate a complete renal response benefit in lupus nephritis in a randomised phase III study²
Lupus nephritis affects more than 1.7 million people worldwide, predominantly women of colour and childbearing age, with up to one-third of patients progressing to end-stage kidney disease^3-6

Basel, 20 October 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) has approved Gazyva®/Gazyvaro®(obinutuzumab) for the treatment of adult patients with active lupus nephritis (LN) who are receiving standard therapy, as well as a shorter 90-minute infusion time after the first infusion, for eligible patients. Following four initial doses in the first year, Gazyva/Gazyvaro can be administered twice yearly, offering an effective and potentially more convenient treatment option than traditional targeted therapies.

“People with lupus nephritis who achieve a complete renal response are more likely to experience preserved kidney function and delay, or even prevention, of progression to end-stage kidney disease,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “The approval of Gazyva/Gazyvaro by the FDA marks an important step towards a potential new standard of care for lupus nephritis, one that could allow clinicians to offer their patients more effective disease control.”

“As a severe and potentially life-threatening disease, lupus nephritis greatly disrupts daily life with chronic pain, fatigue, and the constant fear of worsening kidney health,” said Louise Vetter, President and Chief Executive Officer, Lupus Foundation of America. “The FDA’s approval of Gazyva/Gazyvaro offers renewed hope for people with lupus nephritis and their loved ones, as it provides an important new treatment option that has the potential to prevent long-term complications, including kidney failure.”

This approval is based on positive results from the phase II NOBILITY and phase III REGENCY studies. In REGENCY, data showed that nearly half of the participants (46.4%) on Gazyva/Gazyvaro in combination with standard therapy achieved a complete renal response (CRR) compared to 33.1% on standard therapy alone. This was accompanied by clinically meaningful improvements in complement levels and reductions in anti-dsDNA, corticosteroid use, and proteinuria, all signalling improved disease control. The safety profile of Gazyva/Gazyvaro was consistent with the well-characterised profile observed in its haematology-oncology indications.²

Lupus nephritis affects more than 1.7 million people worldwide.^3,4 It disproportionately impacts women, mostly women of colour and of childbearing age, who often face more severe disease.⁶ If left untreated, up to one-third of individuals can progress to end-stage kidney disease, which often requires dialysis or transplantation.⁵

Gazyva/Gazyvaro was granted Breakthrough Therapy Designation by the FDA in 2019 based on data from the phase II NOBILITY study. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recently issued a positive opinion recommending the approval of Gazyva/Gazyvaro for adults with active lupus nephritis, with a final decision from the European Commission expected in the near future.

Gazyva/Gazyvaro is being investigated in people with systemic lupus erythematosus, membranous nephropathy, idiopathic nephrotic syndrome, and in children and adolescents with lupus nephritis.^8-11 In addition to Gazyva/Gazyvaro, Roche has a broad pipeline targeting the immune drivers of rare and common kidney and kidney-related diseases.

About Gazyva/Gazyvaro
Gazyva®/Gazyvaro® (obinutuzumab) is a Type II engineered humanised monoclonal antibody designed to attach to CD20, a protein found on certain types of B cells.¹² In lupus nephritis, disease-causing B cells drive persistent inflammation that damages the kidneys and reduces their ability to function properly.¹³ Data suggests that Gazyva/Gazyvaro depletes disease-causing B cells, helping to limit further damage to the kidneys and potentially preventing or delaying progression to end-stage kidney disease.²

Gazyva/Gazyvaro is already approved in 100 countries for various types of haematological cancers. In the United States, Gazyva/Gazyvaro is part of a collaboration between Genentech and Biogen.

About the REGENCY study
REGENCY [NCT04221477] is a phase III, randomised, double-blind, placebo-controlled, multicentre study investigating the efficacy and safety of Gazyva®/Gazyvaro® (obinutuzumab) plus standard therapy (mycophenolate mofetil and glucocorticoids) in people with active/chronic International Society of Nephrology/Renal Pathology Society 2003 proliferative Class III or IV lupus nephritis, with or without Class V. The study enrolled 271 people, who were randomised 1:1 to receive either Gazyva/Gazyvaro plus standard therapy or placebo plus standard therapy. REGENCY was designed based on robust phase II data and conducted during the COVID-19 pandemic. The study population was representative of the real-world population of people with lupus nephritis.

About lupus nephritis
Lupus nephritis is a potentially life-threatening manifestation of systemic lupus erythematosus, an autoimmune disease that commonly affects the kidneys.⁷ Lupus nephritis is characterised by an irreversible loss of nephrons, the filtering structures of the kidneys. Periods of intense disease activity, known as flares, can speed up the loss of nephrons and, if left unchecked, may lead to a progressive loss of kidney function. Even with the latest treatments, up to a third of people will progress to end-stage kidney disease, where dialysis or transplant are the only options and life expectancy and quality of life are substantially reduced.⁵

Lupus nephritis affects more than 1.7 million people worldwide - predominantly women, mostly of colour and usually of childbearing age.⁶ Currently, there is no cure.⁷

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

References
[1] Furie RA, et al. B-cell depletion with obinutuzumab for the treatment of proliferative lupus nephritis: a randomised, double-blind, placebo-controlled trial. Ann Rheum Dis. 2022 Jan;81(1):100-07.

[2] Furie RA, et al. Efficacy and safety of obinutuzumab in active lupus nephritis. N Engl J Med. 2025 Feb;392:1471-83.

[3] Tian J, et al. Global epidemiology of systemic lupus erythematosus: a comprehensive systematic analysis and modelling study. Annals of the Rheumatic Diseases. 2023 Mar;82:351-56.

[4] Bastian HM, et al. Systemic lupus erythematosus in three ethnic groups. XII. Risk factors for lupus nephritis after diagnosis. Lupus. 2002;11(3):152-60.

[5] Mok C, et al. Treatment of lupus nephritis: consensus evidence and perspectives. Nat Rev Rheumatol. 2023 Apr;19(4):227-38.

[6] Anders HJ et al. Lupus nephritis. Nat Rev Dis Primers. 2020 Jan 23;6(1):7.

[7] Hocaoglu M et al. Incidence, prevalence, and mortality of lupus nephritis: a population-based study over four decades using the Lupus Midwest Network. Arthritis & Rheumatol 2023 A.pr;75(4):567-5.

[8] Clinicaltrials.gov. A study to evaluate the efficacy and safety of obinutuzumab in participants with systemic lupus erythematosus (ALLEGORY). [Internet; cited 2025 October 9]. Available from: https://clinicaltrials.gov/study/NCT0496329 6.

[9] Clinicaltrials.gov. A study evaluating the efficacy and safety of obinutuzumab in participants with primary membranous nephropathy (MAJESTY). [Internet; cited 2025 October 9]. Available from: https://clinicaltrials.gov/study/NCT04629248.
[10] Clinical trials.gov. A study to evaluate the efficacy and safety of obinutuzumab versus MMF in participants with childhood onset idiopathic nephrotic syndrome (INShore). [Internet; cited 2025 October 9]. Available from: https://clinicaltrials.gov/study/NCT05627557.
[11] Clinicaltrials.gov. A study to evaluate the efficacy, safety, and pharmacokinetics of obinutuzumab in adolescents with active class III or IV lupus nephritis and the safety and PK of obinutuzumab in pediatric participants (POSTERITY). [Internet; cited 2025 October 9]. Available from: https://clinicaltrials.gov/study/NCT05039619.

[12] Herter S, et al. Preclinical activity of the type II CD20 antibody GA101 (obinutuzumab) compared with rituximab and ofatumumab in vitro and in xenograft models. Mol Cancer Ther. 2013 Oct;12(10):2031-42.

[13] Atisha-Fregoso Y, et al. Meant to B: B cells as a therapeutic target in systemic lupus erythematosus. J Clin Investig. 2021 Jun 15;131(12):e149095.

Roche Global Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

Hans Trees, PhD Phone: +41 79 407 72 58	Sileia Urech Phone: +41 79 935 81 48
Nathalie Altermatt Phone: +41 79 771 05 25	Lorena Corfas Phone: +41 79 568 24 95
Simon Goldsborough Phone: +44 797 32 72 915	Karsten Kleine Phone: +41 79 461 86 83
Kirti Pandey Phone: +49 172 6367262	Yvette Petillon Phone: +41 79 961 92 50
Dr Rebekka Schnell Phone: +41 79 205 27 03

Roche Investor Relations

Dr Bruno Eschli Phone: +41 61 68-75284 e-mail: bruno.eschli@roche.com	Dr Sabine Borngräber Phone: +41 61 68-88027 e-mail: sabine.borngraeber@roche.com
Dr Birgit Masjost Phone: +41 61 68-84814 e-mail: birgit.masjost@roche.com

Investor Relations North America

Loren Kalm
Phone: +1 650 225 3217
e-mail: kalm.loren@gene.com

Attachment

Media Investor Release FDA approves Gazyva in lupus nephritis English

Giredestrant plus everolimus reduced the risk of disease progression or death by 44% and 62% in ITT and ESR1-mutated populations, respectively, in a post-CDK inhibitor setting, compared with standard-of-care endocrine therapy plus everolimus¹
The giredestrant combination was well tolerated; no new safety signals were observed including no photopsia¹
Overall survival data were immature, but a clear positive trend was seen in both the ITT and ESR1-mutated populations¹
If approved, giredestrant plus everolimus could be the first and only oral selective oestrogen receptor degrader combination in the post-CDK inhibitor setting

Basel, 18 October 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today positive results from the phase III evERA Breast Cancer study. Data showed giredestrant in combination with everolimus significantly reduced the risk of disease progression or death (progression-free survival; PFS) by 44% and 62% in the intention-to-treat (ITT) and ESR1-mutated populations, respectively, compared with standard-of-care endocrine therapy plus everolimus.¹The evERA study is evaluating the investigational giredestrant combination in people with oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer previously treated with cyclin-dependent kinase (CDK) 4/6 inhibitor and endocrine therapy.² This is the first positive head-to-head phase III trial investigating a selective oestrogen receptor degrader-containing regimen versus a standard-of-care combination.²The results are being presented in an oral session at the European Society for Medical Oncology Congress 2025. Data will be shared with health authorities, with the aim of bringing this potential treatment option to people as soon as possible.

“A particularly high unmet need remains for people who become resistant to endocrine therapies and CDK inhibitors. These study results support the potential for the giredestrant combination to become a new standard-of-care for all patients in this setting,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development.

“Resistance to standard-of-care therapies is common in the post-CDK inhibitor setting, and the results from evERA validate using a combination to address this challenge,” said Dr Erica L. Mayer, Medical Oncologist at Dana-Farber Cancer Institute. “The clinically meaningful benefit observed with the giredestrant and everolimus all-oral combination is impressive and speaks to its potential to improve outcomes for patients in need of new treatment options.”

The giredestrant combination demonstrated a statistically significant and clinically meaningful improvement in PFS compared with standard-of-care endocrine therapy plus everolimus.¹ In the ITT population, the median PFS was 8.77 months compared with 5.49 months in the giredestrant and comparator arms, respectively (stratified hazard ratio [HR]=0.56; 95% CI: 0.44-0.71, p-value= <0.0001).¹ In the ESR1-mutated population, the median PFS was 9.99 months compared with 5.45 months in the giredestrant and comparator arms, respectively (HR=0.38; 95% CI: 0.27-0.54, p-value= <0.0001).¹ The PFS benefit was consistent across pre-specified subgroups in both populations.¹ Overall survival (OS) data were immature at the time of analysis, but a clear positive trend has been observed in the ITT (HR=0.69, 95% CI: 0.47-1.00, p-value=0.0473) and ESR1-mutated populations (HR=0.62, 95% CI: 0.38-1.02, p-value=0.0566).¹ Follow-up for OS will continue to next analysis. Giredestrant in combination with everolimus also demonstrated improvements in key secondary endpoints (objective response rate and duration of response) compared with the comparator arm across both patient populations.¹

Adverse events for the giredestrant-based combination were manageable and consistent with the known safety profiles of the individual medicines.¹ No new safety signals were observed, including no photopsia.¹

ER-positive breast cancer accounts for approximately 70% of breast cancer cases.³ Resistance to endocrine therapies, particularly in the post-CDK inhibitor setting, increases the risk of disease progression and is associated with poor outcomes.^3,4 All-oral combination therapies, such as giredestrant plus everolimus, could address this by targeting two different signalling pathways while helping to minimise the impact of treatment on people’s lives without the need for injections.^5,6

Our extensive giredestrant clinical development programme spans multiple treatment settings and lines of therapy, reflecting our commitment to deliver innovative medicines to as many people with ER-positive breast cancer as possible.

About the evERA Breast Cancer study
evERA Breast Cancer [NCT05306340] is a phase III, randomised, open-label, multicentre study evaluating the efficacy and safety of giredestrant in combination with everolimus versus standard-of-care endocrine therapy in combination with everolimus in people with oestrogen receptor-positive, human epidermal growth factor receptor 2-negative locally advanced or metastatic breast cancer who have had previous treatment with cyclin-dependent kinase 4/6 inhibitor and endocrine therapy, either in the adjuvant or locally advanced/metastatic setting.²

The co-primary endpoints are investigator-assessed progression-free survival in the intention-to-treat and ESR1-mutated populations, defined as the time from randomisation to the time when the disease progresses or a patient dies from any cause.² The trial has been enriched for ESR1-mutated patients above the natural prevalence to assess the efficacy in this population. In the post-CDK inhibitor setting, up to 40% of people with ER-positive disease have ESR1 mutations.^7,8 Key secondary endpoints include overall survival, objective response rate, duration of response, clinical benefit rate and safety.²

About giredestrant
Giredestrant is an investigational, oral, next-generation selective oestrogen receptor degrader and full antagonist.⁹

Giredestrant is designed to block oestrogen from binding to the oestrogen receptor, triggering its breakdown (known as degradation) and stopping or slowing down the growth of cancer cells.¹⁰

Giredestrant has an extensive clinical development programme and is being investigated in five company-sponsored phase III clinical trials that span multiple treatment settings and lines of therapy to benefit as many people as possible:

Giredestrant versus standard-of-care endocrine therapy (SoC ET) as adjuvant treatment in ER-positive, human epidermal growth factor receptor 2 (HER2)-negative early-stage breast cancer (lidERA Breast Cancer; NCT04961996)¹¹
Giredestrant plus everolimus versus SoC ET plus everolimus in ER-positive, HER2-negative, locally advanced or metastatic breast cancer (evERA Breast Cancer; NCT05306340)²
Giredestrant plus palbociclib versus letrozole plus palbociclib in ER-positive, HER2-negative, endocrine-sensitive, recurrent locally advanced or metastatic breast cancer (persevERA Breast Cancer; NCT04546009)¹²

Giredestrant plus investigator’s choice of a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor versus fulvestrant plus a CDK4/6 inhibitor in ER-positive, HER2-negative advanced breast cancer resistant to adjuvant endocrine therapy (pionERA Breast Cancer; NCT06065748)¹³
Giredestrant plus Phesgo® (pertuzumab, trastuzumab, and hyaluronidase subcutaneous) versus Phesgo in ER-positive, HER2-positive locally advanced or metastatic breast cancer (heredERA Breast Cancer; NCT05296798)¹⁴

About oestrogen receptor (ER)-positive breast cancer
Globally, the burden of breast cancer continues to grow, with 2.3 million women diagnosed and 670,000 dying from the disease every year.¹⁵ Breast cancer remains the number one cause of cancer-related deaths amongst women, and the second most common cancer type.¹⁶

ER-positive breast cancer accounts for approximately 70% of breast cancer cases.³ A defining feature of ER-positive breast cancer is that its tumour cells have receptors that attach to oestrogen, which can contribute to tumour growth.¹⁷

Despite treatment advances, ER-positive breast cancer remains particularly challenging to treat due to its biological complexity.⁵ Patients often face the risk of disease progression, treatment side effects and resistance to endocrine therapy.^5,18There is an urgent need for more effective treatments that can delay clinical progression and reduce the burden of treatment on people’s lives.^5,18

About Roche in breast cancer
Roche has been advancing breast cancer research for more than 30 years, and it continues to be a major focus of research and development. Our legacy began with the development of the first targeted therapy for human epidermal growth factor receptor 2-positive breast cancer, and we continue to push the boundaries of science to address the complexities of all breast cancer subtypes.

By leveraging our dual expertise in pharmaceuticals and diagnostics, we are dedicated to providing tailored treatment approaches and improving outcomes for every patient, from early to advanced stages of the disease. Together with our partners, we are relentlessly pursuing a cure, as we strive for a future where no one dies from breast cancer.

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

References
[1] Mayer E, et al. Giredestrant (GIRE), an oral selective oestrogen receptor (ER) antagonist and degrader, + everolimus (E) in patients (pts) with ER-positive, HER2-negative advanced breast cancer (ER+, HER2– aBC) previously treated with a CDK4/6 inhibitor (i): Primary results of the Phase III evERA BC trial. Presented at: ESMO Congress; 2025 October 17-21; Berlin, Germany. LBA #16.

[2] ClinicalTrials.gov. A Study Evaluating the Efficacy and Safety of Giredestrant Plus Everolimus Compared With the Physician's Choice of Endocrine Therapy Plus Everolimus in Participants With Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer (evERA Breast Cancer) [Internet; cited 2025 October]. Available from: https://clinicaltrials.gov/study/NCT05306340.

[3] Kinslow C, et al. Prevalence of Estrogen Receptor Alpha (ESR1) Somatic Mutations in Breast Cancer. JNCI Cancer Spectrum; 2022 Oct;6(5):pkac060.

[4] Sahin T, et al. Post-progression treatment options after CDK4/6 inhibitors in hormone receptor-positive, HER2-negative metastatic breast cancer. Cancer Treatment Reviews. 2025 April;135:102924.

[5] Hanker A, et al. Overcoming Endocrine Resistance in Breast Cancer. Canc Cell. 2020 Apr 13;37(4):496–513.

[6] Wood L. A review on adherence management in patients on oral cancer therapies. Eur J Oncol Nurs. 2012 Sept; 16(4):432-38.

[7] Meisel J L, et al. Real-world estrogen receptor 1 (ESR1) testing patterns and results in U.S. patients with metastatic breast cancer, 2018-2024. JCO Oncol Pract 2025;21:579-579.

[8] Chaudhary N, et al. CDK4/6i-treated HR+/HER2- breast cancer tumors show higher ESR1 mutation prevalence and more altered genomic landscape. npj Breast Cancer 2024;10,15.

[9] Martin M, et al. Giredestrant (GDC-9545) vs physician choice of endocrine monotherapy (PCET) in patients (pts) with ER+, HER2– locally advanced/metastatic breast cancer (LA/mBC): Primary analysis of the phase 2, randomised, open-label acelERA BC study. Presented at: The European Society for Medical Oncology Annual Meeting; 2022 September 9-13; Paris, France. Abstract #211MO.

[10] Metcalfe C, et al. GDC-9545: A novel ER antagonist and clinical candidate that combines desirable mechanistic and pre-clinical DMPK attributes. Presented at: San Antonio Breast Cancer Symposium; 2018 December 4-8; San Antonio, Texas, USA. Abstract #P5-04-07.

[11] ClinicalTrials.gov. A Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician's Choice of Adjuvant Endocrine Monotherapy in Participants With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer (lidERA Breast Cancer) [Internet; cited 2025 October]. Available from: https://clinicaltrials.gov/study/NCT04961996.

[12] ClinicalTrials.gov. A Study Evaluating the Efficacy and Safety of Giredestrant Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Participants With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (persevERA Breast Cancer) [Internet; cited 2025 October]. Available from: https://clinicaltrials.gov/study/NCT04546009.

[13] ClinicalTrials.gov. A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/ 6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer) [Internet; cited 2025 October]. Available from: https://clinicaltrials.gov/study/NCT06065748.

[14] ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of Giredestrant in Combination With Phesgo (Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf) Versus Phesgo in Participants With Locally Advanced or Metastatic Breast Cancer (heredERA Breast Cancer) [Internet; cited 2025 October]. Available from: https://clinicaltrials.gov/study/NCT05296798.

[15] World Health Organisation. Breast Cancer [Internet; cited 2025 October]. Available from: https://www.who.int/news-room/fact-sheets/detail/breast-cancer.

[16] World Health Organization. Cancer Today [Internet; cited 2025 October]. Available from: https://gco.iarc.fr/today/en/dataviz/bars?mode=cancer&types=1&group_populations=1&sexes=2&key=asr&age_end=14.

[17] National Cancer Institute. Hormone Therapy for Breast Cancer [Internet; cited 2025 October]. Available from: https://www.cancer.gov/types/breast/breast-hormone-therapy-fact-sheet.

[18] Başaran G, et al. Ongoing unmet needs in treating estrogen receptor-positive/HER2-negative metastatic breast cancer. Cancer Treat Rev. 2018 Feb;63:144-55.

Roche Global Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

Hans Trees, PhD Phone: +41 79 407 72 58	Sileia Urech Phone: +41 79 935 81 48
Nathalie Altermatt Phone: +41 79 771 05 25	Lorena Corfas Phone: +41 79 568 24 95
Simon Goldsborough Phone: +44 797 32 72 915	Karsten Kleine Phone: +41 79 461 86 83
Kirti Pandey Phone: +49 172 6367262	Yvette Petillon Phone: +41 79 961 92 50
Dr Rebekka Schnell Phone: +41 79 205 27 03

Roche Investor Relations

Dr Bruno Eschli Phone: +41 61 68-75284 e-mail: bruno.eschli@roche.com	Dr Sabine Borngräber Phone: +41 61 68-88027 e-mail: sabine.borngraeber@roche.com
Dr Birgit Masjost Phone: +41 61 68-84814 e-mail: birgit.masjost@roche.com

Investor Relations North America

Loren Kalm
Phone: +1 650 225 3217
e-mail: kalm.loren@gene.com

Attachment

Media & Investor Release evERA ESMO

Vamikibart is the first non-steroid targeted therapy designed to address inflammation driving UME and may offer a potential new treatment option for patients
Vision improvements were seen in both pivotal studies, achieving statistical significance in MEERKAT and nominal significance in SANDCAT
The MEERKAT and SANDCAT trials are ongoing and the data will be discussed with health authorities globally

Basel, 17 October 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today results from two phase III studies evaluating the efficacy and safety of two doses of investigational vamikibart (0.25 and 1 mg) compared with a sham procedure that mimics intravitreal (IVT) injections in people with uveitic macular edema (UME).¹ UME is characterised by the buildup of fluid in the macula due to uveitis, an inflammatory condition of the eye, that can result in vision loss.² Across both studies, the primary and secondary endpoint data support the potential for rapid improvements in vision and reductions in macular thickness (swelling in the back of the eye due to retinal fluid) with vamikibart treatment.¹ The data were presented at the American Academy of Ophthalmology annual meeting (AAO 2025) in Orlando, Florida, United States.

“The totality of data from these pivotal vamikibart studies represent an important step towards addressing a clear unmet need for people with uveitic macular edema,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “UME is a major cause of vision loss and blindness in people of working age. We look forward to discussing the data for this potential first-in-class treatment with regulatory authorities.”

“UME is most commonly treated with steroids that, when injected in the eye, are associated with significant side effects such as increased pressure in the eye, which can lead to glaucoma and cataract formation,” said study investigator Eric Suhler MD, MPH, Professor of Ophthalmology at the Casey Eye Institute, Oregon Health & Science University, Portland, United States. “These data seen across multiple endpoints in both phase III studies, along with the overall low rate of treatment-related ocular adverse events, suggest that vamikibart could provide a clinically relevant, locally injectable non-steroid treatment option for people with UME.”

In both trials, a numerically higher proportion of patients treated with vamikibart gained vision, with primary endpoint data demonstrating statistically significant superiority over sham in MEERKAT, though not in SANDCAT.¹ Consistently across both trials, key secondary endpoints showed rapid and clinically meaningful improvements in average change from baseline in best corrected visual acuity (BCVA), and average change from baseline in central subfield thickness (CST), a key measure of macular edema, supporting the overall efficacy profile of vamikibart.¹

The underlying variability of BCVA as an endpoint, along with variations in patient baseline characteristics and concomitant medications, may have influenced the differences in trial primary outcomes and further analyses are currently underway.¹

Vamikibart was generally well tolerated in both studies, with a low incidence of treatment-related ocular adverse events (AEs) and intraocular inflammation (IOI) events, and no events of retinal occlusive vasculitis.¹ The most common AEs (≥5%) in either trial in patients receiving vamikibart were conjunctival hemorrhage and raised intraocular pressure.¹

Key data from the pivotal vamikibart phase III MEERKAT and SANDCAT studies:¹

	MEERKAT (n=245)			SANDCAT (n=256)
	Sham (n=80)	0.25 mg vamikibart (n=74)	1 mg vamikibart (n=78)	Sham (n=82)	0.25 mg vamikibart (n=85)	1 mg vamikibart (n=86)
Primary endpoint: proportion of patients with a 15 letter or more improvement from baseline in best corrected visual acuity (BCVA) at week 16
Difference compared with sham IVT injections	-	19.9% (95% CI: 8.1, 31.4; P=0.0008)	36.9% (95% CI: 23.7, 48.5; P<0.0001)	-	20.7% (95% CI: 7.6, 32.8; P=NS*)	10.9% (95% CI: -1.4, 22.6; P=0.0699)
Secondary endpoint: average change from baseline in BCVA at week 16
Average BCVA change, letters	+3.5	+9.6 (P=0.0002)	+12.8 (P<0.0001)	+5.0	+11.9(P=NS)	+9.2(P=NS)
Secondary endpoint: average change from baseline in central subfield thickness (CST) at week 16
Average CST change, µm	−58.5	−187.5 (P<0.0001)	−196.1 (P<0.0001)	−43.5	−209.7 (P=NS)	−194.7(P=NS)
Tolerability: incidence of treatment-related ocular AEs and IOI events
Proportion of patients experiencing one or more treatment-related ocular AEs	0%	4.1%	1.3%	3.7%	4.7%	3.5%
Proportion of patients experiencing one or more IOI events	0%	4.1%	1.3%	1.2%	3.5%	1.2%

*NS = Nominally Significant

About the MEERKAT and SANDCAT studies
MEERKAT and SANDCAT are identical phase III, global, parallel, multicentre, randomised, double-masked, sham comparator-controlled trials of intravitreal (IVT) vamikibart in uveitic macular edema (UME).^1,3,4 In both trials, patients were randomised and received treatment every four weeks with either 0.25 mg vamikibart, 1 mg vamikibart or sham IVT injection, for up to 16 weeks.^1,3,4 The primary endpoint of both phase III trials was the proportion of participants with a 15 letter or more improvement from baseline in best corrected visual acuity (BCVA) at week 16.^1,3,4 Key secondary endpoints included the average change from baseline in BCVA and CST at week 16.^1,3,4 The safety of vamikibart was assessed through adverse events (AEs) such as treatment related ocular AEs, intraocular inflammation (IOI) and retinal occlusive vasculitis.^1,3,4 The studies included participants with and without prior IVT treatment history and included patients with history of raised IOP and glaucoma.^1,3,4

About uveitic macular edema (UME)
UME is characterised by the buildup of fluid in the macula due to uveitis, an inflammatory eye condition.² Although rare compared to other eye diseases, UME has a disproportionate impact on vision loss and blindness globally.^2,5-10 It is the leading cause of moderate and severe vision loss in people with uveitis, and the most frequent sight threatening complication in uveitis.^7-12 Uveitis accounts for 10% to 20% of blindness in the United States and Europe, and up to 25% of blindness in the developing world.¹³ UME has a significant negative impact on people's quality of life, including physical and mental health, social functioning, and visual function for day-to-day activities such as driving and reading.^12,14,15 Steroids, the current standard of care for UME, are associated with significant serious side effects such as increased pressure in the eye, glaucoma and cataracts, and have recognised efficacy limitations.^16-21

About vamikibart
Vamikibart is an investigational monoclonal antibody that has been specifically engineered for IVT administration.^1,22 It targets interleukin-6 (IL-6), a key cytokine in the inflammatory pathway in UME.^1,22 In the phase I DOVETAIL study, vamikibart provided rapid vision improvements and resolution of macular edema in people with UME.^1,22 Vamikibart was also well tolerated, with no treatment-related serious adverse events reported.²² Based on the promising phase I DOVETAIL data, Roche initiated the two identical phase III vamikibart studies MEERKAT and SANDCAT. Vamikibart is being investigated in retinal diseases with recognised inflammatory pathways, including in people with UME. Vamikibart has orphan drug designation in the United States and European Union.

About Roche in Ophthalmology
Roche is focused on saving people’s eyesight from the leading causes of vision loss through pioneering therapies. Through our innovation in the scientific discovery of new potential drug targets, personalised healthcare, molecular engineering, biomarkers and continuous drug delivery, we strive to design the right therapies for the right patients.

We have the broadest retina pipeline in ophthalmology, which is led by science and informed by insights from people with eye diseases. Our pipeline includes innovative treatments across different modalities, such as antibodies, and gene and cell therapies targeting multiple vision-threatening conditions, including retinal vascular and diabetic eye diseases, geographic atrophy, and autoimmune conditions, such as thyroid eye disease and uveitic macular edema.

Applying our extensive experience, we have already brought breakthrough ophthalmic treatments to people living with vision loss. Susvimo® (previously called Port Delivery System with ranibizumab) 100 mg/mL for intravitreal use via ocular implant is the first United States Food and Drug Administration-approved refillable eye implant for neovascular age-related macular degeneration (nAMD) that continuously delivers a customised formulation of ranibizumab over a period of months. Vabysmo® (faricimab) is the first bispecific antibody approved for the eye, which targets and inhibits two signalling pathways linked to a number of vision-threatening retinal conditions by neutralising angiopoietin-2 and vascular endothelial growth factor-A. Vabysmo is approved around the world for people living with nAMD, diabetic macular edema (DME) and macular edema following retinal vein occlusion (RVO). Lucentis® (ranibizumab injection) was the first treatment approved to improve vision in people with certain retinal conditions.

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

References
[1] Khurana RN, et al. Efficacy and Safety of Vamikibart in Patients With Uveitic Macular Edema: First Report of Phase 3 MEERKAT/SANDCAT Trials. Presented at: the American Academy of Ophthalmology annual meeting (AAO 2025); 2025 October 17; Orlando, Florida, United States.
[2] Massa H, Pipis SY, Adewoyin T, Vergados A, Patra S, Panos GD. Macular edema associated with non-infectious uveitis: pathophysiology, etiology, prevalence, impact and management challenges. OPTH. 2019;Volume 13:1761-1777. doi:10.2147/OPTH.S180580
[3] Hoffmann-La Roche. A Phase III, Multicenter, Randomized, Double-Masked, Sham-Controlled Study to Investigate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Vamikibart Administered Intravitreally in Patients With Uveitic Macular Edema. clinicaltrials.gov; 2025. Accessed October 9, 2025. https://clinicaltrials.gov/study/NCT05642312
[4] Hoffmann-La Roche. A Phase III, Multicenter, Randomized, Double-Masked, Sham-Controlled Study to Investigate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Vamikibart Administered Intravitreally in Patients With Uveitic Macular Edema. clinicaltrials.gov; 2025. Accessed October 9, 2025. https://clinicaltrials.gov/study/NCT05642325
[5] Teper SJ. Update on the Management of Uveitic Macular Edema. J Clin Med. 2021;10(18):4133. doi:10.3390/jcm10184133
[6] Fardeau C, Champion E, Massamba N, LeHoang P. Uveitic macular edema. Eye. 2016;30(10):1277-1292. doi:10.1038/eye.2016.115
[7] Smith JR, Thorne JE, Flaxel CJ, et al. Treatment of Noninfectious Uveitic Macular Edema with Periocular and Intraocular Corticosteroid Therapies: A Report by the American Academy of Ophthalmology. Ophthalmology. 2024;131(9):1107-1120. doi:10.1016/j.ophtha.2024.02.019
[8] Sood G, Patel BC. Uveitic Macular Edema. In: StatPearls. StatPearls Publishing; 2025. Accessed September 11, 2025. http://www.ncbi.nlm.nih.gov/books/NBK562158/
[9] Tomkins-Netzer O, Lightman SL, Burke AE, et al. Seven-Year Outcomes of Uveitic Macular Edema: The Multicenter Uveitis Steroid Treatment Trial and Follow-up Study Results. Ophthalmology. 2021;128(5):719-728. doi:10.1016/j.ophtha.2020.08.035
[10] Matas J, Llorenç V, Fonollosa A, et al. Systemic Regulatory T Cells and IL-6 as Prognostic Factors for Anatomical Improvement of Uveitic Macular Edema. Front Immunol. 2020;11. doi:10.3389/fimmu.2020.579005
[11] Tomkins-Netzer O, Talat L, Bar A, et al. Long-Term Clinical Outcome and Causes of Vision Loss in Patients with Uveitis. Ophthalmology. 2014;121(12):2387-2392. doi:10.1016/j.ophtha.2014.07.007
[12] Tallouzi MO, Moore DJ, Bucknall N, et al. Outcomes important to patients with non-infectious posterior segment-involving uveitis: a qualitative study. BMJ Open Ophth. 2020;5(1). doi:10.1136/bmjophth-2020-00048
[13] Cunningham ET, Zierhut M. Vision Loss in Uveitis. Ocular Immunology and Inflammation. 2021;29(6):1037-1039. doi:10.1080/09273948.2021.2017152
[14] Tomkins-Netzer O, Lightman S, Drye L, et al. Outcome of Treatment of Uveitic Macular Edema: The Multicenter Uveitis Steroid Treatment Trial 2-Year Results. Ophthalmology. 2015;122(11):2351-2359. doi:10.1016/j.ophtha.2015.07.036
[15] Frick KD, Drye LT, Kempen JH, et al. Associations among Visual Acuity and Vision- and Health-Related Quality of Life among Patients in the Multicenter Uveitis Steroid Treatment Trial. Invest Ophthalmol Vis Sci. 2012;53(3):1169. doi:10.1167/iovs.11-8259
[16] Rosenbaum JT, Bodaghi B, Couto C, et al. New observations and emerging ideas in diagnosis and management of non-infectious uveitis: A review. Semin Arthritis Rheum. 2019;49(3):438-445. doi:10.1016/j.semarthrit.2019.06.004
[17] Leandro L, Beare N, Bhan K, et al. Systemic corticosteroid use in UK Uveitis practice: results from the ocular inflammation steroid toxicity risk (OSTRICH) study. Eye. 2021;35(12):3342-3349. doi:10.1038/s41433-020-01336-6
[18] Nguyen QD, Hatef E, Kayen B, et al. A Cross-sectional Study of the Current Treatment Patterns in Noninfectious Uveitis among Specialists in the United States. Ophthalmology. 2011;118(1):184-190. doi:10.1016/j.ophtha.2010.03.029
[19] Fini ME, Schwartz SG, Gao X, et al. Steroid-induced ocular hypertension/glaucoma: Focus on pharmacogenomics and implications for precision medicine. Prog Retin Eye Res. 2017;56:58-83. doi:10.1016/j.preteyeres.2016.09.003
[20] Sen HN, Vitale S, Gangaputra SS, et al. Periocular Corticosteroid Injections in Uveitis: Effects and Complications. Ophthalmology. 2014;121(11):2275-2286. doi:10.1016/j.ophtha.2014.05.021
[21] Rice JB, White AG, Scarpati LM, Wan G, Nelson WW. Long-term Systemic Corticosteroid Exposure: A Systematic Literature Review. Clinical Therapeutics. 2017;39(11):2216-2229. doi:10.1016/j.clinthera.2017.09.011
[22] Sharma S, Suhler E, Lin P, et al. A novel intravitreal anti-IL-6 monoclonal antibody for uveitic macular edema (UME): preliminary results from the phase 1 DOVETAIL study. Invest Ophthalmol Vis Sci. 2023;64(8):5100.

Roche Global Media Relations
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Roche Investor Relations

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Investor Relations North America

Loren Kalm
Phone: +1 650 225 3217
e-mail: kalm.loren@gene.com

Positive recommendation based on phase II NOBILITY and phase III REGENCY data showing Gazyva/Gazyvaro’s superiority over standard therapy alone^1,2

Gazyva/Gazyvaro is the only anti-CD20 antibody to demonstrate a complete renal response benefit in lupus nephritis in a randomised phase III study²
Lupus nephritis is a debilitating condition that severely impacts a person’s quality of life and affects more than 1.7 million people worldwide^3,4

Basel, 17 October, 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Gazyva®/Gazyvaro® (obinutuzumab) in combination with mycophenolate mofetil (MMF) for the treatment of adult patients with active Class III or IV, with or without concomitant Class V, lupus nephritis. These disease classifications describe the extent and nature of damage to the kidneys and renal function. A final decision from the European Commission is expected in the near future.

“As the only anti-CD20 to demonstrate a complete renal response benefit in a randomised phase III study of lupus nephritis, Gazyva/Gazyvaro has the potential to address an important unmet need for many people with this disease,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “Recognising the challenges faced by people with lupus nephritis and their caregivers, Gazyva/Gazyvaro may offer a new treatment option that can limit kidney damage and potentially prevent or delay end-stage kidney disease.”

The recommendation is based on positive results from the phase II NOBILITY and phase III REGENCY studies. In REGENCY, data showed that nearly half of the participants (46.4%) on Gazyva/Gazyvaro plus standard therapy (mycophenolate mofetil and glucocorticoids) achieved a complete renal response (CRR) compared to 33.1% on standard therapy alone. This was accompanied by a statistically significant and clinically meaningful reduction of corticosteroid use, and an improvement in proteinuric response, all signalling improved disease control. The safety profile of Gazyva/Gazyvaro was consistent with the well-characterised profile observed in its haematology-oncology indications.²

Earlier this year, data from the phase III REGENCY study were used to file a supplemental Biologics License Application with the US Food and Drug Administration (FDA). The FDA is expected to make a decision on approval this year.

Gazyva/Gazyvaro is being investigated in systemic lupus erythematosus, membranous nephropathy, idiopathic nephrotic syndrome, and in children and adolescents with lupus nephritis.^5-8 In addition to Gazyva/Gazyvaro, Roche has a broad pipeline dedicated to target the immune drivers of rare and common kidney and kidney-related diseases.

About Gazyva/Gazyvaro

Gazyva®/Gazyvaro® (obinutuzumab) is a Type II engineered humanised monoclonal antibody designed to attach to CD20, a protein found on certain types of B cells.⁹ In lupus nephritis, disease-causing B cells drive persistent inflammation that damages the kidneys and reduces their ability to function properly.¹⁰ Data suggests that Gazyva/Gazyvaro depletes disease-causing B cells, helping to limit further damage to the kidneys and potentially preventing or delaying progression to end-stage kidney disease.²

Gazyva/Gazyvaro is already approved in 100 countries for various types of haematological cancers. In the United States, Gazyva is part of a collaboration between Genentech and Biogen.

About the REGENCY study
REGENCY [NCT04221477] is a phase III, randomised, double-blind, placebo-controlled, multicentre study investigating the efficacy and safety of Gazyva/Gazyvaro® (obinutuzumab) plus standard therapy (mycophenolate mofetil and glucocorticoids) in people with active/chronic International Society of Nephrology/Renal Pathology Society 2003 proliferative Class III or IV lupus nephritis, with or without Class V. The study enrolled 271 people, who were randomised 1:1 to receive either Gazyva/Gazyvaro plus standard therapy or placebo plus standard therapy. REGENCY was designed based on robust phase II data and conducted during the COVID-19 pandemic. The study population was representative of the real-world population of people with lupus nephritis.

About lupus nephritis

Lupus nephritis is a potentially life-threatening manifestation of systemic lupus erythematosus, an autoimmune disease that commonly affects the kidneys.¹¹ Lupus nephritis is characterised by an irreversible loss of nephrons, the filtering structures of the kidneys. Periods of intense disease activity, known as flares, can speed up the loss of nephrons and, if left unchecked, may lead to a progressive loss of kidney function. Even with the latest treatments, up to a third of people will progress to end-stage kidney disease within 10 years, where dialysis or transplant are the only options and life expectancy and quality of life are substantially reduced.¹²

Lupus nephritis affects more than 1.7 million people worldwide - predominantly women, mostly of colour and usually of childbearing age.¹³ Currently, there is no cure for lupus nephritis.¹¹

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

References
[1] Furie RA, et al. B-cell depletion with obinutuzumab for the treatment of proliferative lupus nephritis: a randomised, double-blind, placebo-controlled trial. Ann Rheum Dis. 2022 Jan;81(1):100-07.

[2] Furie RA, et al. Efficacy and safety of obinutuzumab in active lupus nephritis. N Engl J Med. 2025 Feb;392:1471-83.

[3] Tian J, et al. Global epidemiology of systemic lupus erythematosus: a comprehensive systematic analysis and modelling study. Ann Rheum Dis. 2023 Mar;82:351-56.

[4] Bastian HM, et al. Systemic lupus erythematosus in three ethnic groups. XII. Risk factors for lupus nephritis after diagnosis. Lupus. 2002;11(3):152-60.

[5] Clinicaltrials.gov. A study to evaluate the efficacy and safety of obinutuzumab in participants with systemic lupus erythematosus (ALLEGORY). [Internet; cited 2025 October 9]. Available from: https://clinicaltrials.gov/study/NCT0496329 6.

[6] Clinicaltrials.gov. A study evaluating the efficacy and safety of obinutuzumab in participants with primary membranous nephropathy (MAJESTY). [Internet; cited 2025 October 9]. Available from: https://clinicaltrials.gov/study/NCT04629248.
[7] Clinical trials.gov. A study to evaluate the efficacy and safety of obinutuzumab versus MMF in participants with childhood onset idiopathic nephrotic syndrome (INShore). [Internet; cited 2025 October 9]. Available from: https://clinicaltrials.gov/study/NCT05627557.
[8] Clinicaltrials.gov. A study to evaluate the efficacy, safety, and pharmacokinetics of obinutuzumab in adolescents with active class III or IV lupus nephritis and the safety and PK of obinutuzumab in pediatric participants (POSTERITY). [Internet; cited 2025 October 9]. Available from: https://clinicaltrials.gov/study/NCT05039619.

[9] Herter S, et al. Preclinical activity of the type II CD20 antibody GA101 (obinutuzumab) compared with rituximab and ofatumumab in vitro and in xenograft models. Mol Cancer Ther. 2013 Oct;12(10):2031-42.

[10] Atisha-Fregoso Y, et al. Meant to B: B cells as a therapeutic target in systemic lupus erythematosus. J Clin Investig. 2021 Jun 15;131(12):e149095.

[11] Hocaoglu M, et al. Incidence, prevalence, and mortality of lupus nephritis: a population-based study over four decades using the Lupus Midwest Network. Arthritis & Rheumatol 2023 Apr;75(4):567-73.

[12] Mok C, et al. Treatment of lupus nephritis: consensus evidence and perspectives. Nat Rev Rheumatol 2023 Apr;19(4):227-38.

[13] Anders HJ, et al. Lupus nephritis. Nat Rev Dis Primers. 2020 Jan 23;6(1):7.

Roche Global Media Relations
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Media & Investor Release Gazyva Gazyvaro CHMP

Significant progress in bulk RNA sequencing, methylation mapping, multiomics integration, and spatial analyses unlocks research previously out of reach for traditional short read platforms.
Leveraging Roche’s SBX technology, Broad Clinical Labs achieved the new GUINNESS WORLD RECORD™ for fastest DNA sequencing technique in under four hours, in collaboration with Roche Sequencing Solutions and Boston Children’s Hospital.
Wellcome Sanger Institute joins a growing network of early collaborators using SBX technology, driving new insights in genomics research.

Basel, 16 October 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) presented major updates on its innovative sequencing by expansion (SBX) technology at the American Society of Human Genetics (ASHG) 2025 Annual Meeting in Boston, USA. Following its recent unveiling, SBX is already being recognized by early evaluators in the sequencing community for its combination of speed, flexibility, and longer reads, which significantly expands research possibilities.

“These advances reflect the strong momentum behind our innovative sequencing technology and its potential to transform genomic research and clinical applications,” said Matt Sause, CEO of Roche Diagnostics. “By combining high throughput, speed and longer read lengths, the SBX technology has the potential to enable research and applications that were previously not feasible. Our collaborations with Broad Institute, the Wellcome Sanger Institute, and others, demonstrate the immense potential of the SBX technology to tackle some of biology’s biggest challenges.”

Breaking a GUINNESS WORLD RECORD™
The impact of the SBX technology was recognised when Broad Clinical Labs broke the GUINNESS WORLD RECORD™ for the fastest DNA sequencing technique to date, using a human genome processed from a DNA sample to a final variant call file (VCF) in less than four hours. This milestone, achieved in collaboration with Roche Sequencing Solutions and Boston Children’s Hospital, surpasses the previous benchmark of five hours and two minutes.

“Breaking the GUINNESS WORLD RECORD is a remarkable achievement,” said Mark Kokoris, inventor of the SBX chemistry and Head of SBX Technology at Roche. “The true impact lies in what this speed and accuracy mean for the scientific community and for deciphering complex diseases like cancer and neurodegenerative conditions.”

Growing collaborations
At ASHG 2025, Roche also announced a new collaboration with the Wellcome Sanger Institute, marking the start of a multi-project evaluation of SBX’s capabilities across a range of research applications. The Wellcome Sanger Institute is evaluating potential benefits from longer reads and very high throughput from the SBX technology for instance in Bulk RNA sequencing to explore previously undetectable features such as certain spliced Isoforms.

The Wellcome Sanger Institute partnership adds to existing collaborations that includes Hartwig Medical Foundation, Genentech, The University of Tokyo and others, as well as the Broad Institute where we previously announced a strategic collaboration to develop and pilot groundbreaking research applications.

Methylation mapping with SBX-Duplex
Roche has also made significant progress in methylation mapping – the process of identifying and analysing chemical modifications called methyl groups that are added to DNA. These modifications act like switches or dimmers, controlling whether genes are turned on, off, or somewhere in between. The research workflow combines SBX-Duplex, a methodology in which both strands of the target DNA are linked in a single read, with a high-fidelity methylation mapping method, TET-assisted pyridine borane sequencing (TAPS), a technology in development by Watchmaker Genomics.

This high efficiency intra-molecular consensus workflow can have significant advantages in research applications, including liquid biopsy-based cancer detection and identification of novel epigenetic biomarkers.

Spatial sequencing
At the University of Tokyo, researchers working in collaboration with Roche leveraged the speed and workflow adaptability of SBX in spatial sequencing analyses of banked lung cancer tissue with about 15 billion reads in just one hour. This approach allowed them to rapidly and accurately map gene expression within tissue samples at high resolution, providing critical insights into the dynamics of cells within a tumor microenvironment.

Target enrichment
Roche also demonstrated a target enrichment method using SBX-Simplex workflow that leverages Unique Molecular Identifiers (UMIs) to produce high throughput and high accuracy reads with very low inputs. This can potentially benefit Oncology research where high depth is typically required.

The above examples highlight SBX’s potential to support multiomics research at scale, by combining the power of rapid sequencing with the ability to analyse multiple layers of biological information. Such breakthroughs are redefining how researchers approach disease biology and interpret the interplay between genetics, transcriptional activity, and epigenomic changes.

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

References
[1] The SBX technology and analysis tools are in development and not commercially available. The content of this material reflects current study results or design goals.

Roche Global Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

Hans Trees, PhD Phone: +41 79 407 72 58	Sileia Urech Phone: +41 79 935 81 48
Nathalie Altermatt Phone: +41 79 771 05 25	Lorena Corfas Phone: +41 79 568 24 95
Simon Goldsborough Phone: +44 797 32 72 915	Karsten Kleine Phone: +41 79 461 86 83
Kirti Pandey Phone: +49 172 6367262	Yvette Petillon Phone: +41 79 961 92 50
Dr Rebekka Schnell Phone: +41 79 205 27 03

Roche Investor Relations

Dr Bruno Eschli Phone: +41 61 68-75284 e-mail: bruno.eschli@roche.com	Dr Sabine Borngräber Phone: +41 61 68-88027 e-mail: sabine.borngraeber@roche.com
Dr Birgit Masjost Phone: +41 61 68-84814 e-mail: birgit.masjost@roche.com

Investor Relations North America

Loren Kalm
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