Workflow
Columvi (glofitamab)
icon
Search documents
New two-year follow-up of Roche’s Columvi extends overall survival in relapsed or refractory diffuse large B-cell lymphoma patients
Globenewswire· 2025-05-23 05:00
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]
Roche provides update on FDA Advisory Committee meeting on Columvi combination for people with relapsed or refractory diffuse large B-cell lymphoma
Globenewswire· 2025-05-20 18:40
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].
Roche Gets Nod for Expanded Use of Columvi in Lymphoma in Europe
ZACKS· 2025-04-14 14:55
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]