Core Insights - Roche announced two-year follow-up data from the phase III STARGLO study, showing a 40% improvement in overall survival for patients treated with Columvi® (glofitamab) in combination with gemcitabine and oxaliplatin (GemOx) compared to MabThera®/Rituxan® (rituximab) plus GemOx [1][5] Group 1: Study Results - The median follow-up was 24.7 months, with overall survival not reached for the Columvi combination, while it was 13.5 months for the R-GemOx group [1] - The Columvi combination demonstrated a 59% reduction in the risk of disease progression or death (hazard ratio = 0.41, 95% CI: 0.29–0.58) [2] - Among patients achieving complete remission (CR), 89% were alive and 82% maintained remission one year post-treatment [2][5] Group 2: Treatment Implications - Columvi is approved in over 30 countries for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not candidates for autologous stem cell transplant [4] - The combination therapy has been added to the National Comprehensive Cancer Network Clinical Practice Guidelines as a category 1 preferred recommendation for second-line DLBCL treatment [4] - There is an urgent need for rapidly available treatments for DLBCL, as many patients do not have access to the latest therapies [3] Group 3: Safety and Efficacy - The safety profile of the Columvi combination remained consistent with previous analyses, with a higher median number of treatment cycles (11 vs. 4) due to disease progression in the R-GemOx arm [2] - Common adverse events included cytokine release syndrome, generally of low grade [2] Group 4: Company Strategy - Roche aims to provide tailored treatment options through its CD20xCD3 bispecific antibody program, which includes Columvi and other therapies [6][8] - The company is also investigating Columvi in combination with other treatments for previously untreated DLBCL in ongoing studies [9]

Columvi is the first bispecific antibody to show a statistically significant and clinically meaningful 41% survival benefit in R/R DLBCL in the phase III STARGLO study1,2There is an urgent need for effective, immediately available therapies that are broadly accessible to people with transplant-ineligible R/R DLBCLThis first-of-its-kind Columvi combination could provide a much-needed, off-the-shelf and fixed-duration treatment option for patients who face poor prognosisThe clinical and disease characteristic ...

Core Viewpoint - Roche's lymphoma drug Columvi has received European Commission approval for second-line treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) [1][2] Regulatory Approval - The approval was anticipated following a recommendation from the Committee for Medicinal Products for Human Use in February [2] - Columvi is also under review in the United States, with a decision expected on July 20, 2025 [2] Clinical Data - The approval is based on the pivotal phase III STARGLO study, which demonstrated a statistically significant improvement in overall survival when Columvi was used in combination with GemOx compared to MabThera/Rituxan with GemOx [5][6] - The combination treatment showed a 41% reduction in the risk of death versus R-GemOx [6] Safety Profile - The Columvi/GemOx combination exhibited a safety profile consistent with the individual medicines [7] Market Context - DLBCL is the most common form of non-Hodgkin's lymphoma, accounting for approximately one-third of all NHL cases, with an estimated 160,000 new diagnoses globally each year [9] Ongoing Research - Roche is also evaluating Columvi in combination with other treatments in the phase III SKYGLO study for previously untreated DLBCL patients [10] Stock Performance - Year to date, Roche's shares have increased by 9.3%, contrasting with a 6.7% decline in the industry [3]