#China #Suzhou #Innovent Biologics #IBI363 #TAK-928

Innovent Expands Global Phase 3 Study of IBI363/TAK-928 in Immunotherapy-Resistant NSCLC

Innovent Biologics, Inc. has announced an exciting expansion to their global Phase 3 MarsLight-11 clinical trial. This important study, which is examining the efficacy of IBI363 (Takeda RD code TAK-928)—an innovative alpha-biased IL-2/PD-1 bispecific fusion protein—will now also include patients suffering from non-squamous non-small cell lung cancer (NSCLC). The original focus of the trial was primarily on patients with squamous NSCLC whose cancer had progressed after standard chemotherapy and immunotherapy treatments.

Expanding Horizons in Cancer Treatment

This development is a notable milestone in cancer research and immunotherapy. The global MarsLight-11 trial aims to investigate not only the potential effectiveness of IBI363/TAK-928 versus docetaxel in patients with unresectable, locally advanced or metastatic NSCLC who have not seen success with previous treatments, but now also aims to gather data from patients with the non-squamous form of NSCLC. The trial will operate as a multicenter, randomized, controlled study designed to provide a robust comparison between the monotherapy of IBI363 and standard docetaxel treatment.

Innovative Mechanism of IBI363/TAK-928

IBI363/TAK-928 stands out among cancer therapies with its unique mechanism of action. As a bispecific fusion protein, it operates by blocking the PD-1/PD-L1 signaling pathway, while also selectively activating the IL-2 pathway. This dual function is especially beneficial, as it maintains a strong affinity for IL-2Rα while limiting binding to IL-2Rβ and IL-2Rγ, thereby aiming to reduce toxicity often associated with immunotherapy. The intricate design enables the PD-1 binding section of the drug to fortify the immune response directly against tumors.

Ongoing Clinical Trials and Future Prospects

Currently, IBI363/TAK-928 is involved in various clinical trials around the globe. These include pivotal studies focusing on:

• - Immunotherapy-resistant squamous and non-squamous NSCLC.
• - Previously untreated acral and mucosal melanoma in China.
• - Advanced colorectal cancer (CRC) that is refractory or intolerant to standard therapies.

Additionally, multiple Phase Ib/II trials are in progress for NSCLC and CRC, assessing IBI363/TAK-928 in both first-line and subsequent treatment settings across different tumor types. The drug has already achieved significant regulatory milestones, receiving Fast Track Designations from the U.S. FDA and Breakthrough Therapy Designations from the China NMPA.

Collaborations and Future Collaborations

Innovent has established a collaborative partnership with Takeda in October 2025 for the co-development and commercialization of IBI363. This alliance aims to expedite the drug’s journey to the market and maximize its availability to cancer patients worldwide, including those outside the U.S. and greater China.

Innovent's Commitment to Quality

Founded in 2011, Innovent Biologics has dedicated itself to the development of affordable, high-quality biopharmaceuticals targeting critical diseases. With 20 approved products in the market and several others in various stages of clinical trials, Innovent continues to push the boundaries in cancer treatments and beyond. The company highlights the importance of integrity and action in delivering transformative therapies to improve patient outcomes.

For further details on this ongoing trial, clinical data, and innovations in cancer treatment, interested parties can visit Innovent’s official website or follow their updates on social media platforms.