The expanded trial functions as a multicenter, randomized study comparing IBI363 monotherapy against docetaxel for patients with advanced or metastatic disease. By splitting the trial into two independent substudies, researchers aim to capture efficacy data across broader histological types of lung cancer. IBI363/TAK-928, a potential first-in-class bispecific fusion protein, is designed to block the PD-1/PD-L1 pathway while simultaneously and selectively activating the IL-2 pathway to promote tumor-killing activity while minimizing systemic toxicity.
Innovent and Takeda Expand MarsLight-11 Trial for Lung Cancer Drug
Innovent Biologics is widening its global Phase 3 MarsLight-11 trial to include patients with non-squamous non-small cell lung cancer. The study, which evaluates the investigational drug IBI363/TAK-928, now targets both squamous and non-squamous patient populations who have previously failed to respond to chemotherapy and standard immunotherapy treatments.
This development follows a collaborative agreement signed in October 2025 between Innovent and Takeda. Under the partnership, the companies are co-developing the drug globally, with specific commercialization rights divided between the United States, China, and international markets. The asset has already secured two Fast Track Designations from the U.S. FDA and three Breakthrough Therapy Designations from China's NMPA, reflecting its potential in treating resistant oncological conditions.
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