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Roche presents Lunsumio data showing potential across earlier treatment lines in indolent and aggressive lymphomas
Globenewswire· 2025-12-08 21:30
Core Insights - Roche announced new data on Lunsumio® (mosunetuzumab) showcasing its potential in earlier treatment lines for lymphoma patients, presented at the 67th American Society of Hematology Annual Meeting [1] Group 1: Efficacy and Clinical Data - Lunsumio shows promise in combination with lenalidomide for relapsed or refractory follicular lymphoma (FL), with a complete response (CR) rate of 87.0% in a study of 54 patients [2] - In the phase Ib/II GO40516 study, Lunsumio combined with Polivy® demonstrated an overall response rate (ORR) of 77.5% for relapsed or refractory large B-cell lymphoma (LBCL), compared to 50.0% for the control group [3] - Five-year follow-up data from the phase II GO29781 study indicated a 5-year overall survival rate of 78.5% for Lunsumio IV in third-line or later FL [5] Group 2: Safety and Tolerability - Cytokine release syndrome (CRS) events were reported in 27.8% of patients receiving Lunsumio plus lenalidomide, with most being low grade [2] - Adverse events (AEs) in the GO40516 study included neutropenia (40%), infections (45%), and peripheral neuropathy (10%), with no new safety signals identified [3] Group 3: Regulatory and Market Position - Lunsumio is approved in over 60 countries for FL patients who have undergone at least two prior systemic therapies, with ongoing discussions for further approvals [6] - The European Commission recently approved Lunsumio for FL after two or more lines of systemic therapy, with a decision from the US FDA expected soon [7] Group 4: Strategic Development - Roche is committed to exploring new formulations and combinations of Lunsumio and other medicines to enhance patient outcomes and provide diverse treatment options [8] - The company has a robust clinical development program for Lunsumio, targeting various B-cell non-Hodgkin lymphomas and other blood cancers [9]
New two-year follow-up of Roche's Columvi extends overall survival in relapsed or refractory diffuse large B-cell lymphoma patients
GlobeNewswire News Room· 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][4] 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% confidence interval: 0.29–0.58) [2] - Among patients achieving complete remission (CR) at the end of treatment, 89% were alive and 82% maintained remission one year post-treatment [2][4] 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 [3] - The combination of Columvi and GemOx has been added to the National Comprehensive Cancer Network Clinical Practice Guidelines as a category 1 preferred recommendation for second-line DLBCL treatment [3] - There is an urgent need for rapidly available treatments for DLBCL, as many patients do not have access to the latest therapies [2][9] Group 3: Safety and Efficacy - The safety profile of the Columvi combination remained consistent with previous analyses, with a higher rate of adverse events observed, including cytokine release syndrome, which was generally low grade [2][4] - Patients receiving the Columvi combination had a higher median number of treatment cycles (11 versus 4) due to disease progression in the R-GemOx arm [2] Group 4: Company Strategy - Roche is focused on developing tailored treatment options for blood cancers, including the CD20xCD3 bispecific antibody program, which includes Columvi and Lunsumio® [5][7] - The company is also investigating Columvi in combination with other therapies for previously untreated DLBCL in ongoing studies [8]