Roche’s CINtec PLUS Cytology is the only FDA-approved and CE-marked dual-stain test to triage human papillomavirus (HPV)-positive cervical cancer screening test results
Dual-stain biomarkers aid in detection of cervical precancer and may reduce the number of women who undergo unnecessary colposcopy procedures while allowing earlier intervention for those who are at higher risk of developing cervical cancer
This recognition follows the American Society for Colposcopy and Cervical Pathology (ASCCP)’s recent inclusion of dual-stain testing in cervical cancer screening guidelines, as well as other WHO prequalifications of Roche’s cobas HPV test
Basel, 23 September 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the World Health Organization (WHO) has included dual-stain cytology testing in its cervical cancer prevention guideline.1 The Roche CINtec® PLUS Cytology test is the only FDA-approved and CE-marked dual-stain test that helps identify human papillomavirus (HPV)-positive individuals who are most at risk of developing cervical precancer and cancer.
The WHO joins the American Society for Colposcopy and Cervical Pathology (ASCCP), which in March also updated its cervical cancer screening guidelines2 to include dual-stain as a triage test for HPV-positive individuals. If the dual-stain test is positive, the patient is at higher risk of having or developing precancer or cancer, and clinicians should recommend immediate colposcopy. However, if the dual-stain test is negative, the risk of precancer is low and individuals may follow up by retesting at a later time to determine if their body has taken care of the infection and eliminated the risk on its own. This may result in fewer women unnecessarily undergoing colposcopy procedures.
“Adding dual-stain cytology to the WHO guidelines further reinforces the value of our biomarker-based CINtec PLUS Cytology test to identify patients with an elevated risk of cervical cancer,” said Matt Sause, CEO of Roche Diagnostics. “HPV infections can cause cervical cancer, a potentially deadly disease that is highly preventable. Consequently, it is critical to determine who is most at risk.”
The CINtec PLUS Cytology test can simultaneously detect when two biomarkers (p16 and Ki-67) are present within the same cell – a strong indicator that it is undergoing transformation and may turn cancerous. By identifying those individuals who are at higher risk of developing cervical disease, CINtec PLUS Cytology helps provide labs, clinicians and patients with important information to guide patient management. This could reduce the number and frequency of follow-up visits, saving worry, time and money. The test can be performed using the same liquid sample that is used for HPV or Pap cytology testing, eliminating the need for additional or repeat sample collection.
The revised WHO guidelines represent an important step forward in achieving the organisation’s three cervical cancer elimination goals3, and a catalyst for ensuring that 90% of those identified with cervical disease receive appropriate treatment. With the recent news that the WHO has awarded prequalification designation to the cobas® HPV test on the cobas 4800, Roche’s entire portfolio of HPV tests on the 4800, 5800, 6800 and 8800 systems is now WHO prequalification-approved for both clinician-collected and self-collected samples
HPV is the known cause of more than 95% of all cervical cancers.4 Roche’s cervical cancer portfolio includes the cobas HPV test, used for primary screening and co-testing. While Pap cytology can potentially detect abnormalities in the cervix, cobas HPV detects 14 types of high-risk HPV genotypes that put patients at higher risk of developing cervical cancer. It includes results for HPV 16, HPV 18 and 12 other high-risk pooled genotypes.3
The HPV self-collection solution is approved for use with Roche's cobas HPV test. The cobas HPV test runs on the cobas 4800 and the fully automated cobas 5800/6800/8800 Systems, which offer the fastest time to results, providing up to 96 results in about three hours, and 384 results for the cobas 6800 System and 1,056 results for the cobas 8800 System in an eight hour shift. The portfolio also includes CINtec PLUS Cytology, the only FDA-approved dual-stain cytology product and CINtec Histology, the only FDA-cleared p16 biomarker technology that can help pathologists confirm the presence of pre-cancerous cervical lesions. The CINtec PLUS Cytology test can run on the BenchMark ULTRA IHC/ISH system. In countries accepting the CE mark, the CINtec PLUS Cytology test can be used to triage HPV-positive results.
The IMPACT trial, used to validate the clinical performance of the Roche cervical cancer portfolio, had representation from diverse patient segments, including 21 percent Black, 24 percent Hispanic-Latino and 0.3 percent American Indian or Alaskan Native participants.5 This diversity was critical to accurately assess the performance of the cobas HPV test and dual stain cytology in patient populations with higher incident rates of HPV. Learn more now: http://diagnostics.roche.com.
Roche is piloting a disease management software called navify® Cervical Screening. It aims to support health systems to increase adherence to clinical guidelines, reduce under- and over-testing and optimise healthcare resources with an organised approach to screening.
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan
Roche’s CINtec PLUS Cytology is the only FDA-approved and CE-marked dual-stain test to triage human papillomavirus (HPV)-positive cervical cancer screening test results
Dual-stain biomarkers aid in detection of cervical precancer and may reduce the number of women who undergo unnecessary colposcopy procedures while allowing earlier intervention for those who are at higher risk of developing cervical cancer
This recognition follows the American Society for Colposcopy and Cervical Pathology (ASCCP)’s recent inclusion of dual-stain testing in cervical cancer screening guidelines, as well as other WHO prequalifications of Roche’s cobas HPV test
Basel, 23 September 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the World Health Organization (WHO) has included dual-stain cytology testing in its cervical cancer prevention guideline.1 The Roche CINtec® PLUS Cytology test is the only FDA-approved and CE-marked dual-stain test that helps identify human papillomavirus (HPV)-positive individuals who are most at risk of developing cervical precancer and cancer.
The WHO joins the American Society for Colposcopy and Cervical Pathology (ASCCP), which in March also updated its cervical cancer screening guidelines2 to include dual-stain as a triage test for HPV-positive individuals. If the dual-stain test is positive, the patient is at higher risk of having or developing precancer or cancer, and clinicians should recommend immediate colposcopy. However, if the dual-stain test is negative, the risk of precancer is low and individuals may follow up by retesting at a later time to determine if their body has taken care of the infection and eliminated the risk on its own. This may result in fewer women unnecessarily undergoing colposcopy procedures.
“Adding dual-stain cytology to the WHO guidelines further reinforces the value of our biomarker-based CINtec PLUS Cytology test to identify patients with an elevated risk of cervical cancer,” said Matt Sause, CEO of Roche Diagnostics. “HPV infections can cause cervical cancer, a potentially deadly disease that is highly preventable. Consequently, it is critical to determine who is most at risk.”
The CINtec PLUS Cytology test can simultaneously detect when two biomarkers (p16 and Ki-67) are present within the same cell – a strong indicator that it is undergoing transformation and may turn cancerous. By identifying those individuals who are at higher risk of developing cervical disease, CINtec PLUS Cytology helps provide labs, clinicians and patients with important information to guide patient management. This could reduce the number and frequency of follow-up visits, saving worry, time and money. The test can be performed using the same liquid sample that is used for HPV or Pap cytology testing, eliminating the need for additional or repeat sample collection.
The revised WHO guidelines represent an important step forward in achieving the organisation’s three cervical cancer elimination goals3, and a catalyst for ensuring that 90% of those identified with cervical disease receive appropriate treatment. With the recent news that the WHO has awarded prequalification designation to the cobas® HPV test on the cobas 4800, Roche’s entire portfolio of HPV tests on the 4800, 5800, 6800 and 8800 systems is now WHO prequalification-approved for both clinician-collected and self-collected samples
HPV is the known cause of more than 95% of all cervical cancers.4 Roche’s cervical cancer portfolio includes the cobas HPV test, used for primary screening and co-testing. While Pap cytology can potentially detect abnormalities in the cervix, cobas HPV detects 14 types of high-risk HPV genotypes that put patients at higher risk of developing cervical cancer. It includes results for HPV 16, HPV 18 and 12 other high-risk pooled genotypes.3
The HPV self-collection solution is approved for use with Roche's cobas HPV test. The cobas HPV test runs on the cobas 4800 and the fully automated cobas 5800/6800/8800 Systems, which offer the fastest time to results, providing up to 96 results in about three hours, and 384 results for the cobas 6800 System and 1,056 results for the cobas 8800 System in an eight hour shift. The portfolio also includes CINtec PLUS Cytology, the only FDA-approved dual-stain cytology product and CINtec Histology, the only FDA-cleared p16 biomarker technology that can help pathologists confirm the presence of pre-cancerous cervical lesions. The CINtec PLUS Cytology test can run on the BenchMark ULTRA IHC/ISH system. In countries accepting the CE mark, the CINtec PLUS Cytology test can be used to triage HPV-positive results.
The IMPACT trial, used to validate the clinical performance of the Roche cervical cancer portfolio, had representation from diverse patient segments, including 21 percent Black, 24 percent Hispanic-Latino and 0.3 percent American Indian or Alaskan Native participants.5 This diversity was critical to accurately assess the performance of the cobas HPV test and dual stain cytology in patient populations with higher incident rates of HPV. Learn more now: http://diagnostics.roche.com.
Roche is piloting a disease management software called navify® Cervical Screening. It aims to support health systems to increase adherence to clinical guidelines, reduce under- and over-testing and optimise healthcare resources with an organised approach to screening.
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan
Roche’s CINtec PLUS Cytology is the only FDA-approved and CE-marked dual-stain test to triage human papillomavirus (HPV)-positive cervical cancer screening test results
Dual-stain biomarkers aid in detection of cervical precancer and may reduce the number of women who undergo unnecessary colposcopy procedures while allowing earlier intervention for those who are at higher risk of developing cervical cancer
This recognition follows the American Society for Colposcopy and Cervical Pathology (ASCCP)’s recent inclusion of dual-stain testing in cervical cancer screening guidelines, as well as other WHO prequalifications of Roche’s cobas HPV test
Basel, 23 September 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the World Health Organization (WHO) has included dual-stain cytology testing in its cervical cancer prevention guideline.1 The Roche CINtec® PLUS Cytology test is the only FDA-approved and CE-marked dual-stain test that helps identify human papillomavirus (HPV)-positive individuals who are most at risk of developing cervical precancer and cancer.
The WHO joins the American Society for Colposcopy and Cervical Pathology (ASCCP), which in March also updated its cervical cancer screening guidelines2 to include dual-stain as a triage test for HPV-positive individuals. If the dual-stain test is positive, the patient is at higher risk of having or developing precancer or cancer, and clinicians should recommend immediate colposcopy. However, if the dual-stain test is negative, the risk of precancer is low and individuals may follow up by retesting at a later time to determine if their body has taken care of the infection and eliminated the risk on its own. This may result in fewer women unnecessarily undergoing colposcopy procedures.
“Adding dual-stain cytology to the WHO guidelines further reinforces the value of our biomarker-based CINtec PLUS Cytology test to identify patients with an elevated risk of cervical cancer,” said Matt Sause, CEO of Roche Diagnostics. “HPV infections can cause cervical cancer, a potentially deadly disease that is highly preventable. Consequently, it is critical to determine who is most at risk.”
The CINtec PLUS Cytology test can simultaneously detect when two biomarkers (p16 and Ki-67) are present within the same cell – a strong indicator that it is undergoing transformation and may turn cancerous. By identifying those individuals who are at higher risk of developing cervical disease, CINtec PLUS Cytology helps provide labs, clinicians and patients with important information to guide patient management. This could reduce the number and frequency of follow-up visits, saving worry, time and money. The test can be performed using the same liquid sample that is used for HPV or Pap cytology testing, eliminating the need for additional or repeat sample collection.
The revised WHO guidelines represent an important step forward in achieving the organisation’s three cervical cancer elimination goals3, and a catalyst for ensuring that 90% of those identified with cervical disease receive appropriate treatment. With the recent news that the WHO has awarded prequalification designation to the cobas® HPV test on the cobas 4800, Roche’s entire portfolio of HPV tests on the 4800, 5800, 6800 and 8800 systems is now WHO prequalification-approved for both clinician-collected and self-collected samples
HPV is the known cause of more than 95% of all cervical cancers.4 Roche’s cervical cancer portfolio includes the cobas HPV test, used for primary screening and co-testing. While Pap cytology can potentially detect abnormalities in the cervix, cobas HPV detects 14 types of high-risk HPV genotypes that put patients at higher risk of developing cervical cancer. It includes results for HPV 16, HPV 18 and 12 other high-risk pooled genotypes.3
The HPV self-collection solution is approved for use with Roche's cobas HPV test. The cobas HPV test runs on the cobas 4800 and the fully automated cobas 5800/6800/8800 Systems, which offer the fastest time to results, providing up to 96 results in about three hours, and 384 results for the cobas 6800 System and 1,056 results for the cobas 8800 System in an eight hour shift. The portfolio also includes CINtec PLUS Cytology, the only FDA-approved dual-stain cytology product and CINtec Histology, the only FDA-cleared p16 biomarker technology that can help pathologists confirm the presence of pre-cancerous cervical lesions. The CINtec PLUS Cytology test can run on the BenchMark ULTRA IHC/ISH system. In countries accepting the CE mark, the CINtec PLUS Cytology test can be used to triage HPV-positive results.
The IMPACT trial, used to validate the clinical performance of the Roche cervical cancer portfolio, had representation from diverse patient segments, including 21 percent Black, 24 percent Hispanic-Latino and 0.3 percent American Indian or Alaskan Native participants.5 This diversity was critical to accurately assess the performance of the cobas HPV test and dual stain cytology in patient populations with higher incident rates of HPV. Learn more now: http://diagnostics.roche.com.
Roche is piloting a disease management software called navify® Cervical Screening. It aims to support health systems to increase adherence to clinical guidelines, reduce under- and over-testing and optimise healthcare resources with an organised approach to screening.
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan
With the option to self-administer, PiaSky® (crovalimab) has the potential to reduce treatment burden for people with paroxysmal nocturnal haemoglobinuria (PNH) in Europe and their caregivers
Approval is based on COMMODORE 2, where subcutaneous (SC) PiaSky once a month was equivalent to intravenous eculizumab every two weeks
PiaSky advances C5 inhibition through innovative recycling technology, which enables its monthly SC administration
Basel, 27 August 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission has approved PiaSky® (crovalimab), a novel recycling monoclonal antibody that inhibits the complement protein C5, for adults and adolescents (12 years of age or older with a weight of 40 kg and above) with paroxysmal nocturnal haemoglobinuria (PNH) who are either new to, or have been previously treated with C5 inhibitors. PNH is a rare and life-threatening blood condition where red blood cells are destroyed by the complement system – part of the innate immune system – causing symptoms such as anaemia, fatigue and blood clots, and potentially leading to kidney disease.
“People with PNH are often burdened with life-long, frequent intravenous infusions with time-consuming clinic visits, meaning that their lives, as well as their caregivers’ and families’ lives, may revolve around the demands of their treatment,” said Prof. Alexander Röth, M.D., Head of Classical Haematology and Haemostasis at the West German Cancer Centre, University Hospital Essen, Germany. “More flexible treatment options such as PiaSky, which are just as effective but less frequent and can be given more quickly at home, are essential to give people with PNH greater control over their treatment and more independence.”
PiaSky is the first monthly subcutaneous (SC) treatment for PNH in the European Union, with the option to self-administer following adequate training. It provides an alternative option to current C5 inhibitors that require regular intravenous infusions, which could help to reduce treatment burden and disruption to the lives of people with PNH and their caregivers.
“The PiaSky approval brings a new option to the PNH treatment landscape, combining the disease control achievable through C5 inhibition with a cutting-edge recycling technology that enables monthly subcutaneous administration,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We are pleased to bring this new treatment to people with PNH in Europe with the hope it may lessen the treatment burden faced by many living with this condition.”
C5 inhibitors – treatments that block part of the complement system cascade – have been shown to be effective in treating PNH.5 PiaSky has been developed to address the needs of people living with PNH and some of the challenges that accompany these existing treatment options. It advances complement inhibition through its innovative recycling technology, which enables monthly SC administration by allowing the medicine to bind and inhibit the C5 protein multiple times and to act longer in the body with a small volume of medicine.
This approval is based on the results from the Phase III COMMODORE 2 study in people with PNH who have not been previously treated with C5 inhibitors. The study demonstrated that PiaSky, administered as SC injections every four weeks, achieved disease control and was well-tolerated. PiaSky was non-inferior with comparable safety to eculizumab, an existing standard of care C5 inhibitor, given intravenously every two weeks. The rate of adverse events in people treated with PiaSky was similar to treatment with eculizumab.1,2 The application included supportive data from two additional Phase III studies, the COMMODORE 1 study, in people with PNH switching from currently approved C5 inhibitors, and the COMMODORE 3 study in people new to C5 inhibitor treatment in China.
PiaSky is the first monthly SC treatment for PNH, approved in multiple territories around the world, including the US and Japan, based on results of the COMMODORE studies. It is being investigated in a broad clinical development programme, including five Phase III studies and three earlier phase studies in complement-mediated diseases, including PNH, atypical haemolytic uremic syndrome and sickle cell disease.
PiaSky® (crovalimab) is a novel recycling monoclonal antibody that inhibits the complement protein C5 and is designed to block the complement system – a vital part of the innate immune system that acts as the body’s first line of defence against infection. PiaSky has been engineered by Chugai Pharmaceutical Co., Ltd, to address the needs of people living with complement-mediated diseases. It provides patients with a potential for subcutaneous (SC) self-administration following adequate training, an initial intravenous infusion and weekly SC loading doses in the first month of treatment.
PiaSky works by binding to C5, blocking the last step of the complement cascade and delivering rapid and sustained complement inhibition. It is also recycled within the bloodstream, enabling small volume SC administration every four weeks. In addition, PiaSky binds to a different C5 binding site from current treatments, which has the potential to provide a treatment option for people with specific C5 gene mutations who do not respond to current therapies.
The COMMODORE 2 study is a Phase III, randomised, open-label study evaluating the efficacy and safety of PiaSky® (crovalimab) versus eculizumab in people with paroxysmal nocturnal haemoglobinuria who have not been treated previously with C5 inhibitors. The study’s co-primary efficacy endpoints measure transfusion avoidance and control of haemolysis (the ongoing destruction of red blood cells measured by lactate dehydrogenase levels). The adults enrolled in the study were randomised in a 2:1 ratio to be treated with either subcutaneous (SC) PiaSky every four weeks or intravenous eculizumab every two weeks. The participants who were less than 18 years old were included in a non-randomised treatment arm and were treated with SC PiaSky every four weeks.
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan
Roche is committed to supporting all those working to overcome the mpox outbreak by providing access to high-quality Polymerase Chain Reaction (PCR) testing
Roche confirms that its cobas MPXV test, as well as the LightMix® research use only kits, detect the latest mpox virus variants
It is actively working to enhance laboratory testing capacity for mpox worldwide
Basel, 20 August 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it is supporting the international response to the mpox global health emergency with its diagnostic tests developed for mpox, formerly known as monkeypox. Mpox, a viral disease that can spread easily between people and from infected animals, was declared a Public Health Emergency of International Concern by the World Health Organization (WHO) (14 August 2024).
Globally, Roche is partnering with governments, healthcare providers and organisations dedicated to combating the mpox outbreak. More specifically, Roche is actively working with its partners to enhance mpox laboratory capacity worldwide. In addition, Roche provides training for laboratories across the African continent at the Roche Scientific Campus in South Africa, as well as locally.
“Our commitment to support the global response to mpox began in 2022 when we developed a suite of tests to enable global access to rapid and high-quality PCR testing,” said Matt Sause, CEO of Roche Diagnostics. “Diagnostics are essential in addressing emerging public health challenges like mpox, as they enable healthcare providers to identify infected patients, devise effective treatment strategies and take appropriate actions.”
To detect the mpox virus, Roche developed three unique LightMix® Modular Virus kits* for use on either a LightCycler®480 II Instrument*, LightCycler® PRO or cobas® z 480 Analyzer, as well as the cobas® MPXV test for use on the cobas® 6800/8800 Systems.
In May 2022, Roche and its subsidiary TIB Molbiol rapidly developed a new suite of tests that detect the virus that causes mpox and aid in following its epidemiologic spread. The LightMix Modular Orthopox / Monkeypox Virus Kits are assays that detect Orthopoxviruses, including the virus that causes mpox, using a technology called quantitative PCR (qPCR). To do this, the test is performed with a patient sample that is first extracted using an established nucleic acid (NA) extraction method. The assay is then performed on either a LightCycler®480 II Instrument*, LightCycler® PRO or cobas® z 480 Analyzer.
The LightMix Modular Orthopox / Monkeypox Virus kits are intended for use in confirmatory testing (evaluation and validation) in public health labs as Research Use Only, and are designed for research use in the majority of countries worldwide.
In November 2022, the FDA granted Roche Emergency Use authorization (EUA) for the cobas MPXV test for use on the high-throughput cobas 6800/8800 Systems. The cobas MPXV test is an automated, real-time PCR test for the qualitative detection of DNA from the virus (MPXV) that causes mpox in human lesion swabs collected from individuals suspected of mpox infection by their healthcare provider and uses a dual-target approach. This approach ensures that cobas MPXV will continue to detect the virus even if a mutation occurs in one target region.
MPXV was first detected in laboratory monkeys in 1958. The virus is, however, assumed to be transmitted from wild animals such as rodents to people — or from human to human. Symptoms of mpox include fever, chills, headaches, muscle aches, fatigue, swollen lymph nodes and a painful rash that characteristically appears as raised bumps on the skin and tends to be distributed on the face, extremities and genitals. As the disease progresses, these bumps fill with pus and fluid and become umbilicated. They will eventually ulcerate, scab and fall off.
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan
Two-year Phase III data presented at ASRS 2024 show Susvimo’s potential as an alternative to eye injections to treat diabetic macular edema (DME) and diabetic retinopathy (DR)
Safety data were consistent with the known safety profile for Susvimo in people with DME and DR
Additionally, the US FDA has accepted the filing application for Susvimo in DME and DR based on one-year Pagoda and Pavilion study data
Susvimo is a unique therapeutic approach that provides continuous delivery of medicine to the eye through a refillable implant
Basel, 18 July 2024 Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today two-year data from the Phase III Pagoda and Pavilion studies evaluating Susvimo® (Port Delivery System with ranibizumab) for the treatment of diabetic macular edema (DME) and diabetic retinopathy (DR), respectively, the two leading causes of vision loss in adults with diabetes.1-4 Susvimo is the first and only refillable eye implant that provides continuous delivery of a customised formulation of ranibizumab via the Port Delivery Platform.5 The results build on the primary one-year analyses of the Pagoda and Pavilion studies, with Susvimo demonstrating sustained efficacy over two years and safety consistent with the known safety profile for Susvimo in people with DME and DR.6-9 Detailed results were presented at the American Society of Retina Specialists (ASRS) 2024 Annual Meeting in Stockholm, Sweden.
Additionally, the United States (US) Food and Drug Administration (FDA) has accepted Roche’s supplemental Biologics License Application (sBLA) for Susvimo for the treatment of DME and DR. The filing acceptance is based on the one-year results from the Phase III Pagoda and Pavilion studies, which showed that both studies met their primary endpoint.6,7 To date, Susvimo is approved in the US for the treatment of neovascular or ‘wet’ age-related macular degeneration (nAMD).10
“These efficacy and safety results demonstrate that Susvimo can deliver robust vision outcomes over two years for people with diabetic eye diseases that can cause vision loss,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “If approved by the US FDA, Susvimo could bring a new treatment paradigm for diabetic eye diseases. We hope to bring this option to people with diabetic macular edema and diabetic retinopathy as soon as possible to help maintain their vision and potentially their independence.”
Treatment for DME typically involves regular eye injections every one to four months.11-13 In Pagoda, people with DME who received Susvimo refilled every six months achieved non-inferior visual acuity gains compared with those receiving monthly 0.5 mg ranibizumab intravitreal injections. Approximately 95% of patients treated with Susvimo did not need additional treatment with supplemental injections during the primary analyses study period (64 weeks). In Pavilion, people with DR who received Susvimo refilled every nine months achieved superior improvements on the Diabetic Retinopathy Severity Scale (DRSS) compared with participants under monthly clinical observation. No individuals treated with Susvimo needed additional treatment with supplemental injections during the primary analyses study period (52 weeks), compared to 60% in the control arm.
In Pagoda, people with DME receiving Susvimo refilled every six months through approximately two years (112 weeks) continued to maintain improvements in vision gains seen at one year (9.8 eye chart letters). A gain of 9.8 eye chart letters is similar to gaining two more lines on an eye chart. Approximately 95% of individuals did not need additional treatment with supplemental injections. Anatomically, Susvimo showed sustained improvements in central subfield thickness (CST) through week 112. Reduction in CST, a measure of retinal drying, is an indicator of swelling from fluid in the back of the eye caused by unstable, leaky blood vessels.14 The safety data were consistent with the known safety profile for Susvimo in people with DME, with no new safety signals observed. In people treated with Susvimo, no cases of endophthalmitis were reported up to one year and the rate of endophthalmitis through week 112 was 0.7%, compared to 0.8% in the control arm. Refills of Susvimo were resumed in affected participants after successful resolution of endophthalmitis.
In Pavilion, people with DR receiving Susvimo refilled every nine months through approximately two years (100 weeks) maintained DRSS improvements seen at one year. Specifically, at week 100, 80% of Susvimo participants achieved a two-step or greater improvement on the DRSS from pre-implant baseline, and participants who received Susvimo from week 64 either maintained or improved their DRSS score from pre-implant baseline. A two-step or greater improvement in the DRSS is a clinically relevant measure of the decrease in risk for developing vision-threatening complications secondary to diabetes.15,16 Approximately 98% of participants treated with Susvimo did not need additional treatment with supplemental injections. The safety data were consistent with the known safety profile for Susvimo in people with DR, with no new safety signals observed. In people treated with Susvimo, no cases of endophthalmitis were reported up to one year and the rate of endophthalmitis through week 100 was 0.8%. One participant with DR developed endophthalmitis and continued receiving treatment with Susvimo refills after successful resolution.
Roche is focused on saving people’s eyesight from the leading causes of vision loss through pioneering therapies and has the broadest retina pipeline in ophthalmology, which is led by science and informed by insights from people with eye diseases.
Affecting around 29 million people globally, diabetic macular edema (DME) is a vision-threatening retinal condition associated with blindness and decreased quality of life when left untreated.17,18 DME occurs when damaged blood vessels leak into and cause swelling in the macula – the central area of the retina responsible for the sharp vision needed for reading and driving.19,20 The number of people with DME is expected to grow as the prevalence of diabetes increases.
VAccounting for approximately 5% of all cases of visual impairment, diabetic retinopathy (DR) occurs when damage to the blood vessels and the formation of new blood vessels causes blood and/or fluid to leak into the retina – a part of the eye that sends information to the brain, enabling sight.22,23 This leads to swelling, as well as blockage of the blood supply to some areas of the retina. As the condition progresses, vision becomes impaired.22,23 DR affects approximately 103 million people globally, resulting in blindness in almost five million people.
Pagoda (NCT04108156) is a multicentre, randomised, active treatment-controlled, non-inferiority US-based Phase III study evaluating the efficacy, safety and pharmacokinetics of Susvimo® (Port Delivery System with ranibizumab) refilled every six months compared with monthly ranibizumab 0.5 mg intravitreal injections, in 634 people with diabetic macular edema. Participants were randomised 3:2 to receive either Susvimo refilled every six months or continued monthly intravitreal ranibizumab injections. In the Susvimo arm, participants received four loading doses of intravitreal ranibizumab, before Susvimo implantation at week 16. The primary endpoint of the study is a change in best-corrected visual acuity score (the best distance vision a person can achieve – including with correction such as glasses – when reading letters on an eye chart) from baseline at the average of week 60 and week 64. Following primary analyses, participants who were initially randomised to intravitreal injections received Susvimo, with refills every 24 weeks.
Pavilion (NCT04503551) is a multicentre, randomised, US-based Phase III study evaluating the efficacy, safety and pharmacokinetics of Susvimo® (Port Delivery System with ranibizumab) 100 mg/mL refilled every nine months compared with people under monthly clinical observation, in 174 people with diabetic retinopathy without centre-involved diabetic macular edema. Participants were randomised 5:3 to receive either Susvimo with refills every nine months or monthly clinical observation, respectively. In the Susvimo arm, participants received two loading doses of intravitreal ranibizumab, before Susvimo implantation at week 4. The primary endpoint was the proportion of participants with at least a two-step improvement from baseline on the Early Treatment Diabetic Retinopathy Study-Diabetic Retinopathy Severity Scale at week 52. Following the primary analyses, participants initially in the clinical observation arm received two ranibizumab loading doses before Susvimo implantation at week 64.
Susvimo is a refillable eye implant surgically inserted into the eye during a one-time, outpatient procedure. Susvimo continuously delivers a customised formulation of ranibizumab over time.5 Ranibizumab is a vascular endothelial growth factor (VEGF) inhibitor designed to bind to and inhibit VEGF-A, a protein that has been shown to play a critical role in the formation of new blood vessels and the leakiness of the vessels.
The customised formulation of ranibizumab delivered by Susvimo is different from the ranibizumab intravitreal injection, a medicine marketed as Lucentis® (ranibizumab injection)*, which is approved to treat neovascular or ‘wet’ age-related macular degeneration (nAMD) and other retinal diseases. Lucentis* was first approved for nAMD by the United States Food and Drug Administration in 2006.
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 an innovative cell therapy and treatments across multiple vision-threatening conditions, including 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 (US) Food and Drug Administration-approved refillable eye implant for neovascular or ‘wet’ age-related macular degeneration (nAMD) that continuously delivers a customised formulation of ranibizumab over a period of months.5,10 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.11,26,27 Vabysmo is approved around the world for people living with nAMD and diabetic macular edema, and in several countries, including the US and Japan, for macular edema following retinal vein occlusion.27-32 Lucentis® (ranibizumab injection)* was the first treatment approved to improve vision in people with certain retinal conditions.
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan
More than 90% of patients had absence of DME after four years in a pre-specified exploratory endpoint
People treated with Vabysmo sustained vision gains and anatomical improvements, with almost 80% receiving treatment at intervals of three or four months, in an exploratory analysis
The study met all primary endpoints, showing safety data were consistent with Vabysmo’s known safety profile
This is the largest long-term extension dataset in DME to-date, demonstrating consistent positive results in a highly prevalent eye condition
Basel, 17 July 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today new, four-year data from the RHONE-X extension study.1 The study met all primary endpoints, showing that Vabysmo® (faricimab) was well tolerated in people with diabetic macular edema (DME) who received treatment for up to four years.2 Exploratory results from the long-term study showed that Vabysmo continued to preserve vision, dry retinal fluid that can impair sight, and allow extended time between treatments in people with DME.2 These data were presented in a late-breaking oral presentation at The American Society of Retina Specialists (ASRS) 2024 Annual Meeting in Stockholm, Sweden.
“These four-year data build on our pivotal studies and reinforce Vabysmo’s potential to become standard of care treatment for diabetic macular edema (DME), which affects 29 million people worldwide,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We are especially pleased to see that 9 out of 10 patients showed no sign of DME after four years of treatment with Vabysmo, which is an incredible long-term outcome for people living with this condition.”
The RHONE-X study is the largest long-term extension dataset in DME, a leading cause of vision loss in people with diabetes.
“I have been using Vabysmo as a first-line treatment for all the approved indications, including diabetic macular edema, and the positive long-term safety and efficacy results from the RHONE-X study are consistent with my clinical experience for over two years,” said study investigator Arshad M. Khanani, M.D., Director of Clinical Research at Sierra Eye Associates and Clinical Professor at the University of Nevada, Reno, who presented the data at the ASRS.
During RHONE-X, all participants were treated with Vabysmo on a personalised treat-and-extend regimen, where the time between Vabysmo treatments could be increased based on retinal fluid levels and visual acuity. Results of the exploratory analysis showed that at the end of four years, nearly 80% of participants treated with Vabysmo had extended their treatment intervals to every three or four months. Additionally, people treated with Vabysmo maintained the vision improvements and sustained the drying of retinal fluid they achieved during the initial Phase III studies (YOSEMITE and RHINE). In a pre-specified exploratory endpoint, more than 90% of people treated with Vabysmo achieved absence of DME, defined as central subfield thickness (CST) less than 325 microns.2 CST is a measure of swelling from fluid in the back of the eye caused by unstable, leaky blood vessels; reducing CST indicates retinal drying.
To date, Vabysmo is approved in nearly 100 countries for DME and neovascular or ‘wet’ age-related macular degeneration (nAMD).3,5-8 It is also approved in several countries, including the United States and Japan, for the treatment of macular edema following retinal vein occlusion.3,5,9 More than four million doses of Vabysmo have been distributed worldwide since its initial US approval in 2022
RHONE-X is a multicentre two-year extension study designed to evaluate the long-term safety and tolerability of Vabysmo® (faricimab) in 1,474 patients with diabetic macular edema who completed one of the two Phase III studies, YOSEMITE (NCT03622580) or RHINE (NCT03622593).10,11 Patients in YOSEMITE and RHINE were treated with either Vabysmo or 2 mg aflibercept. Patients in RHONE-X were all treated with Vabysmo according to a personalised treatment interval.
The primary objectives were to evaluate the long-term safety and tolerability of Vabysmo, including ocular adverse events (AEs), non-ocular AEs and presence of anti-drug antibodies. The study also had an exploratory objective to assess the long-term efficacy of Vabysmo.
Affecting around 29 million people globally, diabetic macular edema (DME) is a vision-threatening retinal condition associated with blindness and decreased quality of life when left untreated.12,13 DME occurs when damaged blood vessels leak into and cause swelling in the macula – the central area of the retina responsible for the sharp vision needed for reading and driving.14,15 The number of people with DME is expected to grow as the prevalence of diabetes increases.
Roche has a robust Phase III clinical development programme for Vabysmo. The programme includes AVONELLE-X (NCT04777201), an extension study of TENAYA (NCT03823287) and LUCERNE (NCT03823300), evaluating the long-term safety and tolerability of Vabysmo in neovascular or ‘wet’ age-related macular degeneration (nAMD).17 Roche has also initiated several Phase IV studies, including the ELEVATUM (NCT05224102) study of Vabysmo in underrepresented patient populations with diabetic macular edema, the SALWEEN study of Vabysmo in a subpopulation of nAMD highly prevalent in Asia, and the POYANG (NCT06176352) study of Vabysmo in adult treatment-naive patients with choroidal neovascularisation secondary to pathologic myopia.18-20 Roche has also initiated the VOYAGER (NCT05476926) study, a global real-world data collection platform, and supports several other independent studies to further understand retinal conditions with a high unmet need.
Vabysmo is the first bispecific antibody approved for the eye.5,22 It targets and inhibits two signalling pathways linked to a number of vision-threatening retinal conditions by neutralising angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). Ang-2 and VEGF-A contribute to vision loss by destabilising blood vessels, causing new leaky blood vessels to form and increasing inflammation. By blocking pathways involving Ang-2 and VEGF-A, Vabysmo is designed to stabilise blood vessels.22,23 Vabysmo is approved in nearly 100 countries around the world, including the United States (US), Japan, the United Kingdom and the European Union, for people living with neovascular or ‘wet’ age-related macular degeneration and diabetic macular edema, and in several countries, including the US and Japan, for the treatment of macular edema following retinal vein occlusion.3,5,9 Review by other health authorities is ongoing.
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 gene therapies and treatments across multiple vision-threatening conditions, including 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 (US) Food and Drug Administration-approved refillable eye implant for neovascular or ‘wet’ age-related macular degeneration (nAMD) that continuously delivers a customised formulation of ranibizumab over a period of months.24,25 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.5,22,23 Vabysmo is approved around the world for people living with nAMD and diabetic macular edema, and in several countries, including the US and Japan, for macular edema following retinal vein occlusion.3,5-9 Lucentis® (ranibizumab injection)* was the first treatment approved to improve vision in people with certain retinal conditions
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan
After four weeks of treatment, CT-996 demonstrated clinically meaningful weight loss of -7.3% (weight loss in placebo -1.2%; p < 0.001)
Pharmacokinetic data supports a once-daily oral dosing regimen for CT-996
The safety and tolerability profile was consistent with other oral GLP-1 receptor agonists and no unexpected safety signals were observed
Basel, 17 July 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today positive topline results from two arms of an ongoing multi-part Phase I clinical trial for CT-996, an investigational, once-daily, oral small molecule GLP-1 receptor agonist being developed for the treatment of both type 2 diabetes and obesity.1 The data showed that treatment with CT-996 in participants with obesity and without type 2 diabetes resulted in a clinically meaningful placebo-adjusted mean weight loss of -6.1% within four weeks (p <0.001). The full study data will be presented at an upcoming medical meeting.
Obesity is one of the most urgent health challenges in the world with extensive comorbidities, such as type 2 diabetes, cardiovascular disease, liver disease, and chronic kidney disease.2 More than four billion people - about 50% of the world’s population - are estimated to be impacted by obesity or will be overweight by 2035.
"We are pleased to see the clinically meaningful weight loss in people treated with our oral GLP-1 therapy CT-996, which could eventually help patients address both chronic weight management and glycaemic control indications,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Following our data for CT-388, this is the second positive readout in less than three months from our growing metabolic pipeline, which includes both oral and injectable options to address patients' needs across a spectrum of related diseases."
CT-996 was well tolerated, with mostly mild or moderate gastrointestinal-related adverse events, consistent with the safety profile of the incretin drug class. There were no treatment discontinuations related to the study drug.1 The study results also showed that blood levels of CT-996 were largely unaffected either during fasting or after a standardised high-fat meal. Thus, CT-996 could potentially be dosed without regard to meal timing, thereby affording greater dosing flexibility for patients.1 Based on the study data, CT-996 is anticipated to be used not only as a therapy for achieving glycaemic control and inducing weight loss, but also potentially for oral weight maintenance therapy following weight loss induced by injectables.
Despite numerous approved treatments, the trajectory for people with obesity or its comorbidities has not changed significantly; these conditions remain underdiagnosed and undertreated so their impact on society continues to grow.5 Oral and injectable incretin modalities are critical to address the high unmet need. They may not only offer broader access to patients living with obesity, but together, they could also support the prevention of obesity-related comorbidities or complications such as type 2 diabetes and heart disease among many others.
The CT-996-201 trial (NCT05814107) is a multi-part, multi-cohort Phase I randomised, double-blind, placebo-controlled, single- and multiple- ascending dose study designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of CT-996 in otherwise-healthy adults who are overweight or obese, with and without type 2 diabetes. Part 1 was a single ascending dose in 40 participants with overweight or obesity (completed); part 2 was a multiple ascending dose in three sequential cohorts of a total of 25 participants with obesity without type 2 diabetes (completed); part 3 is a multiple ascending dose study in two sequential cohorts of 30 participants with obesity and type 2 diabetes (planned to be initiated in Q4 2024). The primary endpoint of the trial is safety and tolerability of CT-996; secondary endpoints include the assessment of the pharmacokinetics of CT-996, along with its effect on body weight and glucose homeostasis. Based on the current Phase I results, CT-996 will advance into Phase II clinical development.
Affecting around 29 million people globally, diabetic macular edema (DME) is a vision- CT-996 is an investigational, once-daily, oral small molecule GLP-1 receptor agonist being developed for the treatment of both type 2 diabetes and obesity.7 Unlike the endogenous GLP-1 hormone, CT-996 is specifically designed to be a biased GLP-1 receptor agonist that activates cAMP signalling with minimal-to-no beta-arrestin recruitment. These finely-tuned signalling properties are expected to lead to strong glycaemic control, significant weight loss and good tolerability.
Obesity is a heterogeneous disease and our R&D portfolio of incretin-based clinical and preclinical assets has great potential to address patients’ needs by providing treatments as mono and combination therapy for obesity, diabetes and various other cardiometabolic indications. We are developing a broad portfolio of foundational assets that range from orals to injectables, as well as molecules with new modes of action to address the multiple needs of patients living with obesity. Our differentiated incretin portfolio includes:
CT-388, an investigational dual GLP-1/GIP receptor agonist for the treatment of obesity in patients with and without type 2 diabetes, currently in Phase II.
Injected subcutaneously once a week, it is being developed both as a standalone and possibly also in combination, and has the potential to be a best in class therapy for chronic weight management, type 2 diabetes, and could be expanded to other indications.
CT-996, an investigational, once-daily, oral small molecule GLP-1 receptor agonist being developed for the treatment of both type 2 diabetes and obesity, currently in Phase I, with the potential to be a best-in-class oral treatment for type 2 diabetes and chronic weight management.
CT-868, an investigational, once-daily, subcutaneously injected dual GLP-1/GIP receptor agonist currently in Phase II with the potential to be a first in class treatment for glycaemic control as an adjunct to insulin in patients living with type 1 diabetes.
Incretins are gut hormones secreted after food intake that play a role in modulating blood glucose by stimulating insulin secretion and suppress appetite. Emerging scientific data show a wider biologic effect of incretins in multiple organs including the liver, heart and brain, suggesting they may have a broader role in the body beyond glucose modulation. Over the past few years, incretins have been clinically validated as targets and are now the emerging standard of care therapies in obesity, but could also be effective in other metabolic indications, as well as in cardiovascular and chronic kidney disease.
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan
Columvi is the first CD20xCD3 T-cell-engaging bispecific antibody available in Europe to treat the most common and aggressive form of lymphoma
Approval is based on results from the phase I/II NP30179 study, where Columvi given as a fixed course induced early and long-lasting complete responses in people with heavily pre-treated or refractory diffuse large B-cell lymphoma
Columvi is given for a fixed period of time and made to be readily available, providing patients with a treatment end date and treatment-free period
Basel, 11 July 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission (EC) has granted conditional marketing authorisation for Columvi® (glofitamab) for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. With this approval, Columvi is the first CD20xCD3 T-cell-engaging bispecific antibody available to treat people in Europe with the most common and aggressive form of lymphoma following multiple lines of therapy. Columvi has the potential to change the current standard of care in DLBCL. As well as inducing early and long-lasting responses in people with heavily pre-treated or refractory DLBCL, Columvi is designed to be given for a fixed period of time meaning that people have a target end date for their course of treatment and the possibility of a treatment-free period. It is also a chemotherapy-free treatment option that is off-the-shelf, meaning that people do not have to wait for cell collection and genetic engineering - a multistep process that can take several weeks - before starting treatment. This could be particularly important for patients who are at a high-risk of their disease progressing.
DLBCL is an aggressive (fast-growing) type of lymphoma and is one of the most prevalent types of blood cancer among adults.2 Each year in Europe, an estimated 36,000 people are diagnosed with DLBCL.3 While many patients with DLBCL are responsive to initial treatment, four out of ten are not cured with the current standard of care, frontline treatment, and the majority of patients who require subsequent lines of therapy have poor outcomes.4,5
“As pioneers in the development of innovative T-cell-engaging bispecific antibodies, we are delighted that we can now offer Columvi as the first approved treatment of its kind to people in Europe,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We are confident that thanks to its off-the-shelf availability, fixed-duration regimen and durability, Columvi will positively transform the treatment experience for relapsed or refractory diffuse large B-cell lymphoma.”
“As the lead investigator for the NP30179 study, I have seen first-hand the early and long-lasting responses that Columvi can induce, when given to patients for a fixed period of time,” said Michael Dickinson, M.D., Ph.D., principal study investigator and Associate Professor, Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Australia. “It is exciting that with this approval, patients in Europe with heavily pre-treated or refractory diffuse large B-cell lymphoma will now have a new, potentially practice-changing treatment option that will allow them time off of therapy to resume their routine activities, helping to alleviate some of the physical and emotional burdens caused by cancer treatment.”
The approval is based on positive results from a pivotal cohort in the phase I/II NP30179 study, where Columvi given as a fixed course induced early and long-lasting responses in people with R/R DLBCL. Overall, 83.3% of patients were refractory to their most recent therapy, 90% were refractory to any previous line of therapy, and about one-third (35.2%) had received prior CAR T-cell therapy. Results showed that Columvi given as a fixed course, induced a complete response (CR; a disappearance of all signs of cancer) in 35.2% (n =38/108) of people, and 50% (n=54/108) achieved an overall response (OR; the combination of CR and partial response, a decrease in the amount of cancer in their body). Among those who achieved a CR, 74.6% (95% CI: 59.19-89.93) continued to experience a response at 12 months, while the median duration of CR was not reached. The median follow-up for duration of response (DOR) was 12.8 months. Median time to first CR was 42 days (95% CI: 41-47). The most common adverse events (AEs) were cytokine release syndrome (CRS; 64.3%), neutropenia (a reduction in white blood cells [37.7%]), anaemia (30.5%) and thrombocytopenia (low blood platelet count [24.7%]). CRS was generally low grade (Grade 1: 48.1%; Grade 2: 12.3%). One patient discontinued treatment due to CRS.1
Additional data from a larger cohort in the NP30179 study, published in the New England Journal of Medicine reinforce the durability of Columvi. Fixed-duration Columvi resulted in early and long-lasting responses in people with heavily pre-treated or refractory DLBCL, with 39.4% of patients (n=61/155) achieving a CR and a median DOR of 18.4 months. Median time to CR was 42 days (95% CI: 42-44), with the majority of responses reported at the first scheduled response assessment (approximately 1.4 months after the start of treatment). Half of patients (51.6%; n=80/155) achieved an OR. The most common AE was CRS, which was generally low grade (Grade 1: 47.4%; Grade 2: 11.7%) and occurred at initial doses. Columvi-related AEs leading to treatment discontinuation occurred in 3.2% of patients.6
The U.S. Food and Drug Administration (FDA) recently approved Columvi for the treatment of adult patients with R/R DLBCL not otherwise specified or large B-cell lymphoma (LBCL) arising from FL, after two or more lines of systemic therapy for the treatment of people with R/R large B cell lymphoma. Columvi is also approved in Canada for the treatment of adult patients with R/R DLBCL not otherwise specified, DLBCL arising from follicular lymphoma (FL), or primary mediastinal B-cell lymphoma, who have received two or more lines of systemic therapy and are ineligible to receive or cannot receive CAR T-cell therapy or have previously received CAR T-cell therapy. Submissions to additional health authorities worldwide are ongoing.
Roche is continually building on its long-standing expertise in haematology by investigating innovative solutions that redefine treatment standards for patients and improve on existing standards of care. In a broad and industry-leading CD20xCD3 T-cell-engaging bispecific antibody clinical development programme, Roche is exploring the potential of both Columvi and Lunsumio® (mosunetuzumab) in earlier lines of treatment and in combination with other novel and chemotherapy-free agents, such as Polivy® (polatuzumab vedotin), with the goal of providing patients with long-lasting outcomes.
Roche continues to expand Columvi’s clinical development programme, which includes the phase III STARGLO trial, evaluating Columvi in combination with gemcitabine and oxaliplatin (GemOx) versus rituximab in combination with GemOx in patients with second-line plus DLBCL who are ineligible for autologous stem cell transplant. Additional phase III studies are also planned, including in first-line DLBCL.
Columvi is a CD20xCD3 T-cell-engaging bispecific antibody designed to target CD3 on the surface of T-cells and CD20 on the surface of B-cells. Columvi was designed with a novel 2:1 structural format. This T-cell-engaging bispecific antibody is engineered to have one region that binds to CD3, a protein on T-cells, a type of immune cell, and two regions that bind to CD20, a protein on B-cells, which can be healthy or malignant. This dual-targeting brings the T-cell in close proximity to the B-cell, activating the release of cancer cell-killing proteins from the T-cell. A clinical development programme for Columvi is ongoing, investigating the molecule as a monotherapy and in combination with other medicines for the treatment of people with B-cell non-Hodgkin lymphomas, including diffuse large B-cell lymphoma and other blood cancers.
The NP30179 study [NCT03075696] is a phase I/II, multicentre, open-label, dose-escalation and expansion study evaluating the safety, efficacy and pharmacokinetics of Columvi® (glofitamab) in people with relapsed or refractory diffuse large B-cell lymphoma. Outcome measures include complete response rate by an independent review committee (primary endpoint), overall response rate, duration of response, progression-free survival, safety, and tolerability (secondary endpoints).
DLBCL is the most common form of non-Hodgkin lymphoma (NHL), accounting for about one in three cases of NHL.2 DLBCL is an aggressive (fast-growing) type of NHL.2 While it is generally responsive to treatment in the frontline, as many as 40% of people will relapse or have refractory disease, at which time salvage therapy options are limited and survival is short.4,5 Improving treatments earlier in the course of the disease and providing needed alternative options could help to improve long-term outcomes. Each year in Europe, it is estimated that 36,000 people are diagnosed with DLBCL.
Roche has been developing medicines for people with malignant and non-malignant blood diseases for more than 20 years; our experience and knowledge in this therapeutic area runs deep. Today, we are investing more than ever in our effort to bring innovative treatment options to patients across a wide range of haematologic diseases. Our approved medicines include MabThera®/Rituxan® (rituximab), Gazyva®/Gazyvaro® (obinutuzumab), Polivy® (polatuzumab vedotin), Venclexta®/Venclyxto® (venetoclax) in collaboration with AbbVie, Hemlibra® (emicizumab), Lunsumio® (mosunetuzumab) and Columvi® (glofitamab). Our pipeline of investigational haematology medicines includes a T-cell-engaging bispecific antibody cevostamab, targeting both FcRH5 and CD3; Tecentriq® (atezolizumab), a monoclonal antibody designed to bind with PD-L1 and crovalimab, an anti-C5 antibody engineered to optimise complement inhibition. Our scientific expertise, combined with the breadth of our portfolio and pipeline, also provides a unique opportunity to develop combination regimens that aim to improve the lives of patients even further.
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan
OCREVUS subcutaneous (SC) injection offers a new, 10-minute administration of OCREVUS with comparable efficacy and safety to intravenous infusion (IV)
OCREVUS SC provides an additional treatment option without the need for IV facilities, expanding accessibility for patients
Roche is working closely with national health systems in Europe to ensure people with multiple sclerosis can access OCREVUS SC as quickly as possible
Basel, 25 June 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission has granted marketing authorisation for OCREVUS® (ocrelizumab) subcutaneous (SC) for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). OCREVUS SC is a 10-minute injection that maintains the same twice-yearly schedule as the previously approved intravenous (IV) infusion. More than 350,000 people with multiple sclerosis have been treated with OCREVUS IV globally.
“OCREVUS transformed the way multiple sclerosis is treated as the first anti-CD20 therapy approved in this disease. Now, people in the EU with multiple sclerosis can have their medicine administered in just 10 minutes twice per year without needing an IV facility,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “This makes it easier for more people with multiple sclerosis to access their treatment, while also saving time for providers.”
The approval is based on pivotal data from the Phase III OCARINA II trial, which showed non-inferior levels of OCREVUS in the blood, when administered subcutaneously, and a safety and efficacy profile comparable to the IV formulation in patients with RMS and PPMS. OCREVUS SC was well tolerated and no new safety concerns were identified. More than 92% of patients who were surveyed as part of the study reported being satisfied or very satisfied with the SC administration of OCREVUS.
OCREVUS SC was developed to provide an alternative twice-a-year treatment option, in addition to IV, so that the administration of OCREVUS can be matched to the individual needs of patients and healthcare professionals (HCPs). The SC injection was designed to be HCP administered, with the flexibility to administer either in the clinic or in settings outside the clinic. Roche is committed to advancing innovative clinical research programmes to broaden the scientific understanding of multiple sclerosis, further reduce disability progression in RMS and PPMS and improve the treatment experiences for those living with multiple sclerosis.
OCREVUS SC combines OCREVUS with Halozyme Therapeutics’ ENHANZE® drug delivery technology.
OCREVUS is a humanised monoclonal antibody designed to target CD20-positive B cells, a specific type of immune cell thought to be a key contributor to myelin (nerve cell insulation and support) and axonal (nerve cell) damage. This nerve cell damage can lead to disability in people with multiple sclerosis. Based on preclinical studies, OCREVUS binds to CD20 cell surface proteins expressed on certain B cells, but not on stem cells or plasma cells, suggesting that important functions of the immune system may be preserved.
The ENHANZE® drug delivery technology is based on a proprietary recombinant human hyaluronidase PH20 (rHuPH20), an enzyme that locally and temporarily degrades hyaluronan – a glycosaminoglycan or chain of natural sugars in the body – in the subcutaneous space. This increases the permeability of the tissue under the skin, allowing space for OCREVUS to enter, and enabling it to be rapidly dispersed and absorbed into the bloodstream.
OCREVUS is the first and only therapy approved for both RMS (including relapsing-remitting multiple sclerosis [RRMS] and active, or relapsing secondary progressive multiple sclerosis [SPMS], as well as clinically isolated syndrome [CIS] in the U.S.) and PPMS.
OCARINA II (NCT05232825) was a Phase III, global, multicentre, randomised study that evaluated the pharmacokinetics, safety and clinical and radiological efficacy of the subcutaneous (SC) formulation of OCREVUS compared with OCREVUS intravenous (IV) infusion in 236 patients with relapsing multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS).
The trial met its primary and secondary endpoints, demonstrating SC injection was non-inferior to IV infusion based on OCREVUS levels in the blood, and comparable control of clinical (relapses) and radiological (MRI lesions) disease activity. The safety profile of OCREVUS SC was also consistent with the well-established safety profile of OCREVUS IV.
Multiple sclerosis is a chronic disease that affects more than 2.9 million people worldwide. Multiple sclerosis occurs when the immune system abnormally attacks the insulation and support around nerve cells (myelin sheath) in the central nervous system (brain, spinal cord and optic nerves), causing inflammation and consequent damage. This damage can cause a wide range of symptoms, including weakness, fatigue and difficulty seeing, and may eventually lead to disability. Most people with multiple sclerosis experience their first symptom between 20 and 40 years of age, making the disease the leading cause of non-traumatic disability in younger adults.
People with all forms of multiple sclerosis experience disease progression – permanent loss of nerve cells in the central nervous system – from the beginning of their disease even if their symptoms aren’t apparent or don’t appear to be getting worse. Delays in diagnosis and treatment can negatively impact people with multiple sclerosis, in terms of their physical and mental health, and contribute to the negative financial impact on the individual and society. An important goal of treating multiple sclerosis is to slow, stop and ideally prevent progression as early as possible.
Relapsing-remitting multiple sclerosis (RRMS) is the most common form of the disease and is characterised by episodes of new or worsening signs or symptoms (relapses) followed by periods of recovery. Approximately 85% of people with multiple sclerosis are initially diagnosed with RRMS. The majority of people who are diagnosed with RRMS will eventually transition to secondary progressive multiple sclerosis (SPMS), in which they experience steadily worsening disability over time. Relapsing forms of multiple sclerosis (RMS) include people with RRMS and people with SPMS who continue to experience relapses. Primary progressive multiple sclerosis (PPMS) is a debilitating form of the disease marked by steadily worsening symptoms but typically without distinct relapses or periods of remission. Approximately 15% of people with multiple sclerosis are diagnosed with the primary progressive form of the disease. Until the FDA approval of OCREVUS, there had been no FDA-approved treatments for PPMS and OCREVUS is still the only approved treatment for PPMS.
Neuroscience is a major focus of research and development at Roche. Our goal is to pursue groundbreaking science to develop new treatments that help improve the lives of people with chronic and potentially devastating diseases.
Roche is investigating more than a dozen medicines for neurological disorders, including neuromuscular diseases: Duchenne muscular dystrophy, facioscapulohumeral muscular dystrophy and spinal muscular atrophy; neuro immune diseases: multiple sclerosis and neuromyelitis optica spectrum disorder; and neurodegenerative diseases: Alzheimer’s disease, Huntington’s disease and Parkinson’s disease. Together with our partners, we are committed to pushing the boundaries of scientific understanding to solve some of the most difficult challenges in neuroscience today.
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan