India Pharma Outlook Team | Thursday, 11 December 2025
Roche today released new three-year data showing that Columvi in combination with GemOx continues to deliver major survival gains for people with relapsed or refractory DLBCL who are not candidates for transplant.
After a median 35.1-month follow-up in the phase III STARGLO study, overall survival remained twice as long with the Columvi regimen compared with R-GemOx, reaching 25.5 months versus 12.5 months.
The benefit held across key subgroups, with the strongest results seen in patients treated in the second-line setting. Among those who had received one prior therapy, 54.6% were still alive at 36 months, and median overall survival with Columvi plus GemOx was not reached.
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Median progression-free survival rose to 20.4 months, far above the 5.5 months seen with R-GemOx. Patients with early relapse, often the hardest to treat, achieved a 56% complete response rate and a 36-month overall survival rate of 46.1%.
“At three years, we see flattening of the overall survival curve, suggesting the possibility of cure for relapsed/refractory DLBCL patients treated with glofitamab-GemOx,” said Jeremy Abramson, MD, Director, Jon and Jo Ann Hagler Center for Lymphoma at the Mass General Brigham Cancer Institute, US, and principal investigator of the STARGLO study.
“By prolonging survival, this Columvi combination could offer people with relapsed or refractory DLBCL long-term remission… therapy,” said Levi Garraway, MD, PhD, Roche’s chief medical officer and head of global product development.
Safety remained consistent with earlier findings, with cytokine release syndrome as the most common event and no new signals identified. Immune recovery appeared 18–24 months after treatment completion.
Backed by STARGLO, the regimen is now approved in more than 50 countries and included in major global guidelines. Roche is also advancing Columvi across first-line DLBCL and mantle cell lymphoma through ongoing phase III studies.
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