European Commission approves Roche’s Lunsumio subcutaneous for relapsed or refractory follicular lymphoma

Core Viewpoint - Roche has received conditional marketing authorization from the European Commission for Lunsumio® (mosunetuzumab) subcutaneous (SC) for treating adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy, based on the phase I/II GO29781 study results [1][3]. Group 1: Product Details - Lunsumio SC can be administered via a one-minute subcutaneous injection, significantly reducing treatment administration time compared to the 2-4 hour intravenous (IV) infusion [2]. - The treatment is designed to provide flexibility and improve the patient experience, aligning with individual clinical requirements and lifestyle preferences [2][8]. - The drug has shown a favorable benefit-risk profile with high rates of deep and durable remissions in patients with third-line or later FL [3][8]. Group 2: Clinical Study Insights - The GO29781 study demonstrated pharmacokinetic non-inferiority of Lunsumio SC compared to IV administration, with an overall response rate (ORR) of 74.5% and a complete response (CR) rate of 58.5% in patients treated with the SC formulation [7]. - The median duration of CR for patients receiving Lunsumio SC was 20.8 months [7]. - Common adverse events included injection-site reactions (60.6%), fatigue (35.1%), and cytokine release syndrome (CRS) [9]. Group 3: Ongoing Research and Development - Phase III studies involving Lunsumio SC are ongoing, including the MorningLyte trial, which investigates its use in combination with lenalidomide in previously untreated FL [5]. - Roche continues to explore new formulations and combinations of Lunsumio and other bispecific antibodies to enhance treatment options for patients [5]. Group 4: Market Context - Follicular lymphoma is the most common slow-growing form of non-Hodgkin lymphoma, with over 110,000 new cases diagnosed annually worldwide [10]. - The disease typically becomes harder to treat with each relapse, highlighting the need for effective treatment options like Lunsumio [10].