Swiss pharmaceutical giant Roche (SWX: ROG) has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its bispecific antibody (BsAb), Lunsumio (mosunetuzumab). This therapy targets CD20 and CD3 and is designed to treat adult patients with recurrent or refractory follicular lymphoma (R/R FL) who have previously received at least two lines of systemic treatment.
Lunsumio: A Pioneering CD20/CD3 BsAb for Follicular Lymphoma
Lunsumio is the world’s first CD20/CD3 BsAb specifically for follicular lymphoma and follows the footsteps of Columvi (glofitamab), another CD20/CD3 BsAb from Roche that was approved in China in November of the previous year for the treatment of recurrent or refractory diffuse large B-cell lymphoma (DLBCL).
Positive Results from GO29781 Study Lead to NMPA Approval
The NMPA’s decision to grant approval was based on the positive results from the multi-center, open-label Phase I/II GO29781 study. This study assessed the safety and anti-tumor activity of mosunetuzumab in R/R FL patients who had received two or more prior treatments. Key findings from the study indicated an objective response rate (ORR) of 80%, a complete response rate (CR) of 60%, and a 3-year overall survival (OS) rate of 82.4%. Notably, the CR in the high-risk POD24 subgroup was 60%, aligning with the overall patient population. Mosunetuzumab demonstrated a favorable safety profile, with the most common adverse event being cytokine release syndrome (CRS), predominantly of low-grade (1-2 grades).-Fineline Info & Tech
