Roche’s Columvi combination shows sustained survival benefit at three-year follow up of pivotal phase III STARGLO study

Core Insights - Roche announced three-year follow-up data from the pivotal phase III STARGLO study, demonstrating that Columvi® (glofitamab) in combination with gemcitabine and oxaliplatin (GemOx) significantly improves overall survival (OS) for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) compared to MabThera®/Rituxan® (rituximab) plus GemOx [1][6] Study Results - After a median follow-up of 35.1 months, the OS for patients treated with Columvi plus GemOx was 25.5 months, compared to 12.5 months for those receiving R-GemOx, resulting in a hazard ratio (HR) of 0.60 [1] - Subgroup analyses indicated that patients who had received one prior line of therapy (2L) had a median OS that was not reached with Columvi, while the R-GemOx arm had a median OS of 14.4 months (HR=0.58) [2] - The median progression-free survival (PFS) for Columvi plus GemOx was 20.4 months compared to 5.5 months for R-GemOx (HR=0.41) [2] Efficacy and Safety - The complete response rate in patients with early relapse (within 12 months) was 56.0%, with a 36-month OS rate of 46.1% [2] - The safety profile of the combination remained consistent with previous findings, with cytokine release syndrome (CRS) being the most common adverse event at 44.8% [4] Global Recognition and Approval - Columvi in combination with GemOx has been approved in over 50 countries, including the EU, UK, Canada, Australia, China, and Mexico, and is included in multiple international treatment guidelines [5][6] - The combination is recognized for its potential to provide long-term remission and improve the quality of life for patients with R/R DLBCL [3][6] Future Developments - Roche is exploring the potential of Columvi in other settings, including first-line DLBCL and mantle cell lymphoma (MCL), with ongoing studies such as the phase III SKYGLO study [8]