Columvi, in combination with chemotherapy, demonstrated a statistically significant improvement in overall survival for people with relapsed or refractory diffuse large B-cell lymphoma
Data from the STARGLO study will be submitted to health authorities and presented at an upcoming medical meeting
Basel, 15 April 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the Phase III STARGLO study met its primary endpoint of overall survival. The study demonstrated that people with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), who have received at least one prior line of therapy and are not candidates for autologous stem cell transplant, lived longer when treated with Columvi® (glofitamab) in combination with gemcitabine and oxaliplatin (GemOx) versus MabThera®/Rituxan® (rituximab) in combination with GemOx. Safety of the combination appeared consistent with the known safety profiles of the individual medicines. The data will be submitted to health authorities and shared at an upcoming medical meeting.
“People with this aggressive lymphoma facing relapse or progression after initial treatment have limited options – particularly those who are ineligible for stem cell transplant,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Building on Columvi’s established benefits, these data demonstrate the potential of this combination regimen to improve survival outcomes in earlier lines of treatment.”
Columvi was the first fixed-duration bispecific antibody to receive accelerated approval by the U.S. Food and Drug Administration and conditional marketing authorisation from the European Commission to treat people with R/R DLBCL after two or more lines of systemic therapy. These approvals were based on positive results of Columvi as a monotherapy from the pivotal Phase I/II NP30179 study in patients with R/R DLBCL who had previously received two or more prior treatments.
Columvi is a CD20xCD3 T-cell engaging bispecific antibody designed to be off-the-shelf and ready for infusion, so patients can start treatment soon after diagnosis. This is particularly important for patients with highly aggressive disease who are at risk of rapid disease progression. Columvi is given as a fixed-duration treatment, offering people with R/R DLBCL who have failed two or more lines of therapy a treatment end date and the possibility of a treatment-free period, unlike continuous treatments.
About the STARGLO study
The STARGLO study [GO41944; NCT04408638] is a Phase III, multicentre, open-label, randomised study evaluating the efficacy and safety of Columvi® (glofitamab) in combination with gemcitabine plus oxaliplatin (GemOx) versus MabThera®/Rituxan® (rituximab) in combination with GemOx in patients with diffuse large B-cell lymphoma who have received at least one prior line of therapy and who are not candidates for autologous stem cell transplant.1 Outcome measures include overall survival (primary endpoint), progression-free survival, complete response rate, objective response rate, duration of objective response (secondary endpoints), and safety and tolerability.
About Columvi® (glofitamab)
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. Columvi is part of Roche’s broad and industry-leading CD20xCD3 T-cell-engaging bispecific antibody clinical development programme that also includes Lunsumio® (mosunetuzumab), which aims to provide tailored treatment options that suit the diverse needs, preferences, and experiences of people with blood cancers and healthcare systems. Roche is investigating Columvi as a monotherapy and in combination with other medicines, including Polivy® (polatuzumab vedotin), in earlier lines of treatment for people with B-cell non-Hodgkin lymphomas, including diffuse large B-cell lymphoma and other blood cancers.
About diffuse large B-cell lymphoma (DLBCL)
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.3 Improving treatments earlier in the course of the disease and providing much needed alternative options could help to improve long-term outcomes. Approximately 160,000 people worldwide are diagnosed with DLBCL each year.
About Roche in haematology
Roche has been developing medicines for people with malignant and non-malignant blood diseases for more than 25 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 T-cell engaging bispecific antibody cevostamab, targeting both FcRH5 and CD3, Tecentriq® (atezolizumab), 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.
About Roche
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