Innovent Expands Phase 3 MarsLight-11 Trial of IBI363/TAK-928 to Non-Squamous NSCLC
核心洞察
Innovent Biologics (搜索) has expanded the global Phase 3 MarsLight-11 trial of IBI363/TAK-928 (搜索) to add a second substudy enrolling patients with non-squamous NSCLC.
Each substudy compares IBI363 monotherapy against docetaxel in unresectable, locally advanced or metastatic NSCLC that progressed on platinum chemotherapy and anti-PD-1 (搜索)/PD-L1 therapy.
IBI363/TAK-928 (搜索) is a potential first-in-class alpha-biased IL-2/PD-1 (搜索) bispecific fusion protein co-developed globally by Innovent and Takeda under an October 2025 agreement.
Innovent Biologics (搜索) has expanded the global Phase 3 MarsLight-11 (NCT07217301) trial of IBI363 (Takeda R&D code: TAK-928 (搜索)) to include patients with non-squamous non-small cell lung cancer (搜索) (NSCLC), adding a second substudy to a study that previously enrolled only patients with squamous disease.
The evaluation in non-squamous NSCLC will run as a new substudy of MarsLight-11, a global, multicenter, randomized, controlled Phase 3 study. MarsLight-11 will now comprise two independent substudies, one in squamous NSCLC and one in non-squamous NSCLC. Each substudy will assess 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 (搜索)/PD-L1 immunotherapy.
A bispecific designed to bias IL-2 signaling
IBI363/TAK-928 (搜索) is a potential first-in-class alpha-biased IL-2/PD-1 (搜索) bispecific fusion protein being co-developed by Innovent and Takeda. It acts by both blocking the PD-1/PD-L1 pathway and selectively activating the IL-2 pathway.
The IL-2 arm of the molecule is designed to maintain its affinity for IL-2R alpha (搜索) while reducing binding to IL-2R beta and IL-2R gamma, with the aim of minimizing toxicity. The PD-1 (搜索) binding arm blocks PD-1 and selectively delivers IL-2 to the tumor.
Development program spans several tumor types
Beyond MarsLight-11, IBI363/TAK-928 (搜索) is being evaluated in a series of clinical trials globally. These include a pivotal Phase II study in China in previously untreated acral and mucosal melanoma (搜索), a global multicenter Phase III trial in immunotherapy-resistant squamous and non-squamous NSCLC, and a pivotal Phase III study in China in advanced colorectal cancer (搜索) (CRC) refractory or intolerant to standard therapy.
In parallel, multiple Phase Ib/II trials are evaluating the candidate in NSCLC and CRC, including first-line and later-line settings, and in additional tumor types.
The program has received two Fast Track Designations from the U.S. Food and Drug Administration (搜索) and three Breakthrough Therapy Designations from China's National Medical Products Administration (搜索).
Collaboration and company profile
In October 2025, Innovent entered into a license and collaboration agreement with Takeda under which the two companies will co-develop IBI363 globally and co-commercialize it in the U.S., while Takeda will exclusively commercialize the asset worldwide outside the U.S. and greater China.
Innovent, founded in 2011, discovers, develops, manufactures and commercializes medicines for cancer, cardiovascular and metabolic, autoimmune and eye diseases. The company states it has launched 20 products, with one asset under NMPA review, five assets in Phase 3 or pivotal clinical trials, and 20 more molecules in early clinical stage. It has entered into more than 30 strategic partnerships with global organizations including Eli Lilly, Roche, Takeda, Pfizer, Sanofi, Incyte, and MD Anderson Cancer Center.
Innovent notes that it does not recommend the use of any unapproved drug or indication.