Innovent Biologics, Inc. has announced the 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 a 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, randomised, controlled phase 3 study.

MarsLight-11 will therefore be comprised of 2 independent substudies—1 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.

IBI363/TAK-928 is a potential first-in-class alpha-biased IL-2/PD-1 bispecific fusion protein being co-developed by Innovent and Takeda. It functions by both blocking the PD-1/PD-L1 pathway and selectively activating the IL-2 pathway. The IL-2 arm of IBI363/TAK-928 is designed to maintain its affinity for IL-2Rα while reducing binding to IL-2Rβ and IL-2Rγ, with the aim of minimising toxicity. The PD-1 binding arm not only blocks PD-1 but also selectively delivers IL-2 to the tumor.

IBI363/TAK-928 is being evaluated in a series of clinical trials globally, including a pivotal phase 2 study in China in previously untreated acral and mucosal melanoma, a global multi-center phase 3 trial in immunotherapy-resistant squamous and non-squamous NSCLC; a pivotal phase 3 study in China in advanced CRC refractory or intolerant to standard therapy.

In parallel, multiple phase 1b/2 trials are evaluating IBI363/TAK-928 in NSCLC and CRC including the first-line and later line settings, and in additional tumor types.

IBI363/TAK-928 has received 2 Fast Track Designations (FTDs) from the US Food and Drug Administration (FDA) and 3 Breakthrough Therapy Designations (BTD) from China National Medical Products Administration (NMPA), so far.

In October 2025, Innovent entered into a license and collaboration agreement with Takeda, under which Innovent and Takeda will co-develop IBI363 (Takeda R&D code: TAK-928) globally and co-commercialise IBI363/TAK-928 in the US, and Takeda will exclusively commercialise IBI363/TAK-928 worldwide other than the US and greater China.