The BLA was based on the P-I/II (GO29781) trial evaluating mosunetuzumab. The US FDA decision for approval of the novel cancer immunotherapy is expected on Dec 29, 2022
The results showed high & durable CR rates, responders maintained responses for 18mos. & has manageable tolerability in patients with heavily pretreated FL. After a median follow-up of 18.3mos., the CR rate (60%), ORR (80%), m-DoR (22.8mos.) in those who responded, CRS (39%) with low grade (grade 1: 25.6%; grade 2: 14%; grade 3: 2.3%; grade 4: 0.5%),
The 2 P-III (CELESTIMO & SUNMO) studies are being conducted for mosunetuzumab as part of a comprehensive development program i.e., mosunetuzumab + lenalidomide as 2L+ FL & mosunetuzumab + Polivy (polatuzumab vedotin) in 2L+ DLBC
Ref: Bussinesswire | Image: Organon
