Roche provides update on FDA Advisory Committee meeting on Columvi combination for people with relapsed or refractory diffuse large B-cell lymphoma

Core Viewpoint - Roche's Columvi® (glofitamab) in combination with gemcitabine and oxaliplatin (GemOx) shows significant potential for treating relapsed or refractory diffuse large B-cell lymphoma (DLBCL), with a 41% reduction in risk of death demonstrated in the phase III STARGLO trial, supporting its recent approval in Europe and inclusion in US treatment guidelines [2][5][7]. Group 1: Clinical Trial Results - The STARGLO study enrolled 274 patients across 62 sites in 13 countries, with a majority (52%) from outside Asia, and demonstrated a 41% reduction in risk of death (HR=0.59, p=0.011) for the Columvi-GemOx combination compared to MabThera®/Rituxan® plus GemOx [2][4][9]. - The combination also achieved a 63% reduction in risk of disease worsening or death (HR=0.37, p<0.0001), with median overall survival (OS) of 25.5 months for Columvi compared to 12.9 months for R-GemOx [4][5]. - Safety profiles were consistent with known profiles of individual medicines, although a higher rate of adverse events was observed with the Columvi regimen, particularly cytokine release syndrome [4][5]. Group 2: Regulatory and Market Implications - Columvi has been approved in over 30 countries for patients with R/R DLBCL who are ineligible for autologous stem cell transplant, and it has been added to the National Comprehensive Cancer Network (NCCN) guidelines as a category 1 preferred treatment [7][8]. - The FDA's evaluation of the Columvi combination is ongoing, with a decision expected by July 20, 2025 [8]. Group 3: Patient Population and Treatment Needs - Approximately 75% of patients with R/R DLBCL in the US are not candidates for or do not have access to the latest treatments, highlighting the urgent need for effective therapies [5][6]. - The STARGLO study population is representative of the current US patient demographic, indicating that the results are applicable to the broader patient population [3][5]. Group 4: Company Background and Development - Roche has a long-standing commitment to developing innovative treatments for blood cancers, with Columvi being part of a broader clinical development program that includes other bispecific antibodies [10][14]. - The company is also investigating Columvi in combination with other therapies for earlier stages of DLBCL to improve long-term outcomes [11].