CHMP recommends EU approval of Roche’s subcutaneous formulation of Lunsumio for people with relapsed or refractory follicular lymphoma

Core Viewpoint - Roche announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of a subcutaneous formulation of Lunsumio® (mosunetuzumab) for adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy, with a final decision expected from the European Commission soon [1][2]. Summary by Sections Product Approval and Clinical Data - The CHMP's recommendation is based on the primary analysis of the phase II GO29781 study, which demonstrated pharmacokinetic non-inferiority of subcutaneous Lunsumio compared to intravenous administration, with no unexpected safety signals [2][6]. - The overall objective response rate (ORR) for patients treated with subcutaneous Lunsumio was 74.5% (95% CI: 64.4% - 82.9%), and the complete response (CR) rate was 58.5% (95% CI: 47.9% - 68.6%) [7]. - The median duration of complete response was 20.8 months (95% CI: 18.8-not evaluable) for patients receiving the subcutaneous formulation [7]. Treatment Administration and Patient Experience - Subcutaneous Lunsumio can significantly reduce treatment administration time to approximately one minute per injection, compared to 2-4 hours for intravenous infusion, while maintaining the same dosing schedule [3][8]. - The treatment is designed for a fixed duration of approximately 6-12 months, depending on patient response, allowing for a target end date and the possibility of a treatment-free period [3][8]. Safety Profile - The most common all-grade adverse events included injection-site reactions (60.6%; all Grade 1-2), fatigue (35.1%), and cytokine release syndrome (CRS; 29.8%) [7]. - The rate and severity of CRS were low, with events primarily being low grade (Grade 1-2, 27.7%; Grade 3, 2.1%), occurring during cycle 1 and resolving in a median of two days (range 1-15 days) [2][7]. Company Commitment and Future Directions - Lunsumio is part of Roche's leading CD20xCD3 bispecific antibody portfolio, which includes Columvi® (glofitamab), and the company is committed to exploring new formulations and combinations to enhance patient experience and treatment options [5][11]. - Roche has submitted data from the GO29781 study to other health authorities globally, including the US Food and Drug Administration, for approval consideration [4].