Innovent Biologics announced that the FDA has cleared the investigational new drug (IND) application to initiate a global Phase 3 clinical trial (MarsLight-11) of IBI363 in immunotherapy(IO)-resistant squamous non-small cell lung cancer (NSCLC). IBI363 is Innovent's self-discovered novel PD-1/IL-2α-bias bispecific antibody fusion protein. The upcoming study will be the first global Phase 3 trial of IBI363 and represents a significant milestone in advancing a first-in-class, dual-immune activation immunotherapy for this large patient population
This IND clearance follows recent positive feedback from the U.S. FDA at the End-of-Phase 2 (EOP2) meeting. Major alignments of the Phase 3 program were reached regarding the dose selection, study design, and other critical considerations. Innovent has also received IND approval from China's National Medical Products Administration (NMPA) for this program. In parallel, Innovent has initiated communications and submissions to other major Health authorities. IBI363 has also received Fast Track Designation (FTD) from the FDA and Breakthrough Therapy Designation (BTD) from the National Medical Products Administration (NMPA) in China for this indication.
The multi-regional, randomized, controlled Phase 3 trial will enroll approximately 600 patients globally including China, U.S., Canada, EU, UK, and Japan, etc. The study will evaluate the efficacy and safety of IBI363 3 mg/kg monotherapy compared with docetaxel in patients with unresectable, locally advanced or metastatic squamous NSCLC who have experienced disease progression following platinum-based chemotherapy and anti-PD-1/PD-L1 immunotherapy.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox!
Sign up now!