Phathom Pharmaceuticals begins Phase 3 trial for VOQUEZNA in non-erosive GERD

Innovent Biologics has announced the expansion of its Phase 3 lung cancer trial, MarsLight-11, to include non-squamous non-small cell lung cancer (NSCLC) patients. The trial is assessing the investigational immunotherapy IBI363/TAK-928, a unique alpha-biased IL-2/PD-1 bispecific fusion protein co-developed by Innovent and Takeda.

MarsLight-11 will now consist of two independent substudies, one focusing on squamous NSCLC and the other on non-squamous NSCLC. Each substudy will compare the efficacy and safety of IBI363 monotherapy against docetaxel in unresectable, locally advanced, or metastatic NSCLC patients who have progressed after platinum-based chemotherapy and anti-PD-1/PD-L1 immunotherapy.

IBI363/TAK-928 functions by simultaneously blocking the PD-1/PD-L1 pathway and selectively activating the IL-2 pathway, with the goal of reducing toxicity. The drug has received multiple designations, including Fast Track Designations from the U.S. FDA and Breakthrough Therapy Designations from China NMPA.