Innovent Biologics, Inc. (HKEX Stock Code: 01801), a biopharmaceutical company dedicated to the research, development, manufacturing, and commercialization of innovative drugs for major diseases including oncology, autoimmune, metabolic, and ophthalmic diseases, announces expansion of the global Phase 3 MarsLight-11 (NCT07217301) trial, which is evaluating IBI363 (Takeda R&D code: TAK-928) in patients with squamous non-small cell lung cancer (NSCLC) whose disease has progressed on or after chemotherapy and immunotherapy, to include patients with non-squamous NSCLC. This expansion marks another important milestone in the development of this investigational innovative immunotherapy. IBI363/TAK-928 is a potential first-in-class alpha-biased IL-2/PD-1 bispecific fusion protein being jointly developed by Innovent and Takeda globally.

The evaluation of IBI363/TAK-928 in non-squamous NSCLC will be conducted as a new substudy of MarsLight-11, a global, multicenter, randomized, controlled Phase 3 study. MarsLight-11 will therefore be comprised of two independent substudies—one in squamous NSCLC and the other in non-squamous NSCLC. Each substudy will evaluate the efficacy and safety of IBI363 monotherapy versus docetaxel in patients with unresectable, locally advanced or metastatic NSCLC whose disease has progressed during or after treatment with platinum-based chemotherapy and anti-PD-1/PD-L1 immunotherapy.