Genentech, part of the Roche Group, announced significant results from its Phase III STARGLO study of Columvi® (glofitamab-gxbm) with gemcitabine and oxaliplatin (GemOx) versus Rituxan® (rituximab) with GemOx (R-GemOx) in patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL). These patients had received at least one prior therapy and were not candidates for autologous stem cell transplant or had received two or more prior therapies. Results were presented at the European Hematology Association (EHA) 2024 Congress.
Dr. Jeremy Abramson of Massachusetts General Hospital Cancer Center, the principal investigator, highlighted the significance of these findings as the first to show the potential of a CD20xCD3 bispecific antibody in second or later-line DLBCL treatment for patients ineligible for transplant.
The study’s primary analysis (median follow-up of 11.3 months) showed that Columvi plus GemOx significantly improved overall survival (OS), with a 41% reduction in the risk of death (HR=0.59, p=0.011) compared to R-GemOx. Median OS was not reached with Columvi versus nine months with R-GemOx. Safety profiles were consistent with known profiles of the individual drugs.
Exploratory analyses confirmed the benefits across various subgroups, despite some regional inconsistencies. Dr. Levi Garraway of Genentech emphasized the importance of advancing Columvi combinations for the 40% of patients who relapse or have refractory disease and need alternative treatment options.
Key secondary endpoints were also met, showing a 63% reduction in the risk of disease worsening or death (HR=0.37, p<0.0001). A follow-up analysis (median follow-up of 20.7 months) continued to show benefits, with a median OS of 25.5 months for the Columvi combination versus 12.9 months for R-GemOx, and a higher complete response rate (58.5% vs. 25.3%).
Adverse event rates were higher with the Columvi combination, with the most common being cytokine release syndrome, generally of low grade and primarily occurring in Cycle 1.
Columvi is the first CD20xCD3 bispecific antibody to show a survival benefit in DLBCL in a randomized Phase III trial, offering a potential new treatment option for patients. Results from the STARGLO study will be submitted to global health authorities, including the FDA and the European Medicines Agency. Columvi is also being investigated for other hard-to-treat lymphomas and recently received Breakthrough Therapy Designation from the FDA for relapsed or refractory mantle cell Lymphoma
