Saturday, July 13, 2024

New Phase III Data Shows Columvi’s Potential in DLBCL

Similar articles

Roche’s Phase III STARGLO study has shown promising results for Columvi (glofitamab) in combination with chemotherapy for treating relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The study met its primary endpoint of overall survival, demonstrating a 41% reduction in the risk of death for patients treated with Columvi plus GemOx (gemcitabine and oxaliplatin) compared to those treated with R-GemOx (rituximab plus GemOx). These findings suggest Columvi could provide a much-needed off-the-shelf treatment option for people with transplant-ineligible R/R DLBCL.

The study results, presented at the European Hematology Association (EHA) 2024 Congress, were featured in a Press Briefing and the Plenary Abstracts Session. Dr. Jeremy Abramson, the study’s principal investigator, highlighted that this is the first evidence showing the potential of a CD20xCD3 bispecific antibody in improving second or later-line DLBCL treatment for patients ineligible for transplants. Columvi combined with GemOx showed significant improvement in overall survival and other key secondary endpoints, with benefits sustained over an additional 11 months of follow-up.

The primary analysis (median follow-up of 11.3 months) confirmed the study’s primary endpoint, showing a 41% reduction in the risk of death (hazard ratio [HR]=0.59, 95% CI: 0.40-0.89, p=0.011) for patients treated with Columvi plus GemOx compared to those treated with R-GemOx. Median overall survival (OS) was not reached with the Columvi regimen versus nine months for R-GemOx. The safety of the combination was consistent with the known profiles of the individual medicines, making it a viable option for patients needing alternative treatments.

Pre-specified exploratory subgroup analyses showed comparable results, including consistency across clinically relevant stratification factors like line of therapy (second-line versus third-line+) and outcome of last therapy (relapsed versus refractory). Despite regional inconsistencies due to the exploratory nature and small subgroups with wide confidence intervals, the overall findings support Columvi’s potential benefits.

“This is a significant step in advancing Columvi combinations in earlier treatment settings,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer. “Patients do not have to wait to start treatment with Columvi, which is crucial for those with aggressive disease at risk of rapid progression.”

The Columvi combination also met key secondary endpoints, showing a 63% reduction in the risk of disease worsening or death (progression-free survival, PFS) compared to R-GemOx (HR=0.37; 95% CI: 0.25–0.55, p<0.0001). A follow-up analysis (median follow-up of 20.7 months) indicated continued benefit, with median OS of 25.5 months for the Columvi combination versus 12.9 months for R-GemOx, and more patients experiencing complete responses (58.5% versus 25.3%, respectively).

Adverse event (AE) rates were higher with the Columvi combination, partly due to a higher median number of treatment cycles (11 versus 4). Cytokine release syndrome was a common AE but was generally low grade, occurring primarily in the first cycle. The safety profile remains consistent with the known safety profiles of the individual drugs, supporting its continued evaluation.

phase

olumvi Shows Promise in Treating DLBCL

Columvi is the first CD20xCD3 bispecific antibody to demonstrate a survival benefit in DLBCL in a randomized Phase III trial. This success highlights the potential of such therapeutic combinations to improve survival outcomes in earlier treatment lines. Traditional second-line therapy for R/R DLBCL has been high-dose chemotherapy followed by stem-cell transplant, but not all patients are eligible due to age or other medical conditions. Columvi offers an alternative, fixed-duration treatment that allows patients a treatment-free period, unlike continuous treatments.

The STARGLO study results will be submitted to global health authorities, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency. Columvi is also being investigated in other aggressive lymphomas and was recently granted Breakthrough Therapy Designation by the FDA for relapsed or refractory mantle cell lymphoma based on Phase I/II NP30179 study results.

You can follow our news on our Telegram and LinkedIn accounts.

The STARGLO study (NCT04408638) is a Phase III, multicenter, open-label, randomized study evaluating Columvi in combination with GemOx versus R-GemOx in patients with R/R DLBCL. Outcomes include overall survival, progression-free survival, complete response rate, and safety. This study aims to confirm Columvi’s accelerated approval in the US and conditional marketing authorization in the EU for R/R DLBCL after two or more lines of therapy.

Columvi is a CD20xCD3 T-cell engaging bispecific antibody designed to target CD3 on T-cells and CD20 on B-cells. This dual-targeting activates T-cells to kill cancer cells. Columvi is part of Roche’s extensive CD20xCD3 T-cell-engaging bispecific antibody development program, which includes Lunsumio® (mosunetuzumab). Roche is exploring Columvi as a monotherapy and in combination with other drugs for treating DLBCL and other blood cancers.

DLBCL is the most common form of non-Hodgkin lymphoma (NHL), accounting for about one-third of NHL cases. It is an aggressive type of NHL, with up to 40% of patients relapsing or having refractory disease. Improving treatments earlier in the disease course and providing alternative options could significantly improve long-term outcomes. Around 160,000 people are diagnosed with DLBCL annually worldwide.

Roche has been developing treatments for malignant and non-malignant blood diseases for over 25 years. Today, Roche invests heavily in innovative treatments for a wide range of hematologic diseases. Roche’s approved medicines include MabThera®, Gazyva®, Polivy®, Venclexta®, Hemlibra®, Lunsumio®, and Columvi®. Investigational medicines include cevostamab, Tecentriq®, and crovalimab.

 

Resource: Roche, June 15, 2024

Subscribe to our newsletter

To be updated with all the latest news, offers and special announcements.

Latest article