Innovent Biologics expands Phase 3 lung cancer trial globally
Biopharmaceutical manufacturer Innovent Biologics expanded its global Phase 3 MarsLight 11 clinical trial of candidate IBI363 TAK 928 to evaluate patients with immunotherapy resistant non squamous non small cell lung cancer
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.
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