Roche reports Phase 3 STARGLO study met primary endpoint

Roche announced statistically significant and clinically meaningful results from its Phase III STARGLO study of Columvi in combination with gemcitabine and oxaliplatin versus MabThera/Rituxan in combination with GemOx for people with relapsed or refractory diffuse large B-cell lymphoma, or DLBCL, who have received at least one prior line of therapy and are not candidates for autologous stem cell transplant, or who have received two or more prior lines of therapy. Data were featured in the congress Press Briefing and presented in the Plenary Abstracts Session at the European Hematology Association, or EHA, 2024 Congress as a late-breaking oral presentation. The primary analysis confirmed that the study met its primary endpoint of overall survival, or OS, demonstrating that patients treated with Columvi plus GemOx lived significantly longer, with a 41% reduction in the risk of death versus R-GemOx. Median OS was not reached with the Columvi regimen versus nine months for R-GemOx. Safety of the combination appeared consistent with the known safety profiles of the individual medicines. “The results from STARGLO are the first to show the potential of a CD20xCD3 bispecific antibody to make a difference in second or later-line DLBCL in people who are ineligible for transplant and have limited options. Glofitamab in combination with GemOx showed clinically significant improvement in overall survival, as well as key secondary endpoints, and the benefits were reinforced with an additional 11 months of follow-up,” said Jeremy Abramson, M.D., Director, Jon and Jo Ann Hagler Center for Lymphoma at the Massachusetts General Hospital Cancer Center, and principal investigator of the STARGLO study.