Innovent Biologics said it is expanding its global Phase 3 MarsLight-11 trial of IBI363, also known as TAK-928, to include patients with non-squamous non-small cell lung cancer. The study had been evaluating the treatment in patients with squamous NSCLC whose disease progressed on or after chemotherapy and immunotherapy, the company said in the release.
The non-squamous evaluation will run as a new substudy of MarsLight-11, a global, multicenter, randomized, controlled Phase 3 study. The trial will now consist of two independent substudies, one in squamous NSCLC and one in non-squamous NSCLC. Each will compare IBI363 monotherapy with docetaxel in patients with unresectable, locally advanced or metastatic NSCLC whose disease has progressed during or after platinum-based chemotherapy and anti-PD-1/PD-L1 immunotherapy.
Innovent described IBI363/TAK-928 as a potential first-in-class alpha-biased IL-2/PD-1 bispecific fusion protein that it is developing jointly with Takeda globally. The company said the molecule works by blocking the PD-1/PD-L1 pathway while selectively activating the IL-2 pathway, with the IL-2 arm designed to keep its affinity for IL-2Rα while reducing binding to IL-2Rβ and IL-2Rγ to limit toxicity, and the PD-1 binding arm delivering IL-2 to the tumor.
The company said the treatment is being studied in a series of trials worldwide, including a pivotal Phase II study in China in previously untreated acral and mucosal melanoma, the global Phase III trial in immunotherapy-resistant squamous and non-squamous NSCLC, and a pivotal Phase III study in China in advanced colorectal cancer refractory or intolerant to standard therapy. It added that multiple Phase Ib/II trials are evaluating the molecule in NSCLC and CRC, including first-line and later-line settings, and in other tumor types. The company also said IBI363/TAK-928 has received two Fast Track Designations from the U.S. FDA and three Breakthrough Therapy Designations from China's NMPA.
Innovent and Takeda entered a license and collaboration agreement in October 2025 covering global co-development of the molecule and co-commercialization in the U.S., with Takeda to exclusively commercialize it worldwide outside the U.S. and greater China, according to the announcement. Innovent said it does not recommend the use of any unapproved drug or indication.
