Polivy® (polatuzumab vedotin)
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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]