Biopharmaceutical company Innovent Biologics Inc (HKEX: 01801) announced on Sunday that the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application to start 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-2-alpha-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.

The multi-regional, randomized, controlled Phase 3 trial will enrol approximately 600 patients globally including China, US, Canada, EU, UK and Japan. 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. The primary endpoint is overall survival.