The U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application to begin a global Phase 3 clinical trial for IBI363, as announced by Innovent Biologics. This novel PD-1/IL-2α-bias bispecific antibody fusion protein is a self-discovered asset by Innovent and is intended for the treatment of immunotherapy (IO)-resistant squamous non-small cell lung cancer (NSCLC). This trial, named MarsLight-11, is a significant milestone as it represents the first global Phase 3 study for IBI363. The drug has also received Fast Track Designation from the FDA and Breakthrough Therapy Designation from China’s National Medical Products Administration (NMPA) for this indication. The trial will be a multi-regional, randomized, controlled study, enrolling approximately 600 patients across various countries, including China, the U.S., Canada, EU, UK, and Japan. The primary endpoint will be overall survival, and the trial will compare the efficacy and safety of IBI363 monotherapy against docetaxel in patients whose disease has progressed after previous platinum-based chemotherapy and anti-PD-1/PD-L1 immunotherapy.

The clearance for this IND follows positive feedback from the U.S. FDA at the End-of-Phase 2 meeting, where alignment was reached on key aspects of the study design. Clinical research of IBI363 has already shown promising results, with Phase 1b/2 data presented at ASCO 2025 demonstrating meaningful and durable clinical activity in areas of high unmet need, such as IO-resistant lung cancer and other difficult-to-treat cancers.

The drug's mechanism involves simultaneously blocking the PD-1/PD-L1 pathway and activating the IL-2 pathway, while an engineered design minimizes toxicity. This dual-action approach aims to more precisely and effectively stimulate tumor-specific T cells.

Innovent is advancing IBI363 into registrational studies, with a pivotal program in melanoma already underway and a global Phase 3 trial in squamous NSCLC expected to begin soon. The company is also planning a registration strategy for colorectal cancer. Additionally, multiple Phase 1b/2 trials are ongoing to evaluate IBI363 as both a monotherapy and in combination with other drugs for various tumor types, including first-line NSCLC, first-line colorectal cancer, and platinum-resistant ovarian cancer. This comprehensive development strategy is part of Innovent’s broader global innovation strategy, which aims to bring transformative treatments to patients worldwide and expand its impact in oncology on a global scale.