FDA approves Roche’s Lunsumio VELO™ for subcutaneous use in relapsed or refractory follicular lymphoma

Core Viewpoint - Roche's Lunsumio VELO™ (mosunetuzumab) has received FDA approval as a subcutaneous treatment for adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy, based on the phase I/II GO29781 study results [1][3][4] Group 1: FDA Approval and Treatment Benefits - The FDA approval is based on the results from the GO29781 study, which demonstrated an objective response rate of 75% and a complete response rate of 59% in patients treated with Lunsumio VELO [3][7] - Lunsumio VELO significantly reduces treatment administration time to approximately one minute, compared to the previous 2-4 hour intravenous infusion, thus aligning treatment with patient needs [2][7] - The treatment can be administered in outpatient settings and is designed for a fixed duration, potentially as short as six months, contrasting with indefinite treatment options [2][3] Group 2: Clinical Study Insights - The GO29781 study evaluated the safety, efficacy, and pharmacokinetics of mosunetuzumab in patients with relapsed or refractory B-cell non-Hodgkin lymphoma, establishing efficacy based on objective response rate and duration of response [6] - The median duration of response for Lunsumio VELO was reported as 22.4 months [3] - The most common adverse reactions (≥20%) included injection site reactions, fatigue, rash, and cytokine release syndrome (CRS), with a CRS rate of 30% primarily occurring during Cycle 1 [3][4] Group 3: Ongoing Research and Development - Roche is advancing its bispecific antibody program in lymphoma, with ongoing phase III studies evaluating Lunsumio and Lunsumio VELO in earlier lines of treatment [5] - The SUNMO study is investigating Lunsumio VELO in combination with Polivy® for second-line or later large B-cell lymphoma, while the MorningLyte study is exploring its use with lenalidomide in previously untreated follicular lymphoma [5] Group 4: Follicular Lymphoma Overview - Follicular lymphoma (FL) is the most common slow-growing form of non-Hodgkin lymphoma, accounting for about 20% of cases, and is characterized by periods of remission and relapse [8] - More than 110,000 people are diagnosed with FL each year worldwide, and the disease typically becomes harder to treat with each relapse [8]