Innovent and Takeda expand the Phase 3 MarsLight-11 trial of IBI363/TAK-928 to non-squamous NSCLC after chemotherapy and immunotherapy.
Written By: Siddhi Bhadekar, M. Pharm (QA)
Reviewed By: Pharmacally Editorial Team
Innovent Biologics has expanded the global Phase 3 MarsLight-11 trial (NCT07217301) of IBI363, also known as TAK-928, to include patients with non-squamous non-small cell lung cancer (NSCLC). The investigational alpha-biased IL-2/PD-1 bispecific fusion protein is being evaluated in patients with unresectable, locally advanced or metastatic NSCLC whose disease has progressed during or after platinum-based chemotherapy and anti-PD-1/PD-L1 immunotherapy.
Phase 3 Program Expands Across NSCLC Subtypes
MarsLight-11 will now comprise two independent substudies, one enrolling patients with squamous NSCLC and the other enrolling patients with non-squamous NSCLC. Each substudy will compare IBI363 monotherapy with docetaxel as the chemotherapy control arm.
The trial targets a later-line population with limited treatment options after progression on chemotherapy and immune checkpoint blockade. In the existing squamous NSCLC study, patients are randomized 1:1 to IBI363 or docetaxel. The planned primary endpoint is overall survival, while secondary endpoints include progression-free survival, objective response rate, disease control rate, duration of response, time to response, safety, pharmacokinetics and immunogenicity.
Dual PD-1 and IL-2 Activity
IBI363/TAK-928 combines PD-1 blockade with selective IL-2 pathway activation in a single bispecific fusion protein.
Its PD-1-binding component blocks the PD-1/PD-L1 pathway and enables selective delivery of the IL-2 component to the tumor. The IL-2 arm retains affinity for IL-2 receptor alpha (IL-2Rα) while reducing binding to IL-2Rβ and IL-2Rγ. This alpha-biased configuration is intended to promote immune activation while limiting broader IL-2 receptor engagement and associated toxicity.
Broader Clinical Development
The expansion follows earlier clinical evaluation of IBI363 in both squamous and non-squamous NSCLC. The program also includes a pivotal Phase 2 study in previously untreated acral and mucosal melanoma and a pivotal Phase 3 study in China for advanced colorectal cancer refractory or intolerant to standard therapy. Additional Phase 1b/2 studies are evaluating the drug in NSCLC, colorectal cancer and other solid tumors.
IBI363 has received two Fast Track Designations from the U.S. Food and Drug Administration (FDA) and three Breakthrough Therapy Designations from China’s National Medical Products Administration (NMPA).
Innovent-Takeda Collaboration
The development program follows the October 2025 collaboration between Innovent and Takeda. Under the agreement, the companies will jointly develop IBI363/TAK-928 globally and co-commercialize it in the United States. Takeda holds exclusive commercialization rights outside the United States and greater China.
Next Clinical Milestones for IBI363 in NSCLC
The addition of non-squamous NSCLC broadens the pivotal development program to the two major histologic categories of NSCLC. The new substudy will now determine whether IBI363 can provide clinically meaningful benefit compared with docetaxel in patients whose disease has progressed after platinum-based chemotherapy and PD-1/PD-L1 immunotherapy.
No efficacy results from the newly added non-squamous Phase 3 substudy have been reported with the expansion announcement. Future data from MarsLight-11 will therefore be important in determining the regulatory path for IBI363/TAK-928 in immunotherapy-resistant NSCLC.
Reference
Innovent Announces Expansion of Global Phase 3 MarsLight-11 Study of IBI363/TAK-928 (Alpha-biased IL-2/PD-1 Bispecific Fusion Protein) in Immunotherapy-Resistant NSCLC to Include Patients with Non-Squamous NSCLC, Innovent, 28 September 2026
A Study Comparing TAK-928 With Docetaxel in Adults with Non-Small Cell Lung Cancer (MarsLight-11), ClinicalTrials.gov ID NCT07217301
About the Writer
Siddhi Rajendra Bhadekar (Linkedin) is an M.Pharm professional with expertise in medical and scientific writing, literature review, publication writing, and evidence synthesis, supported by four peer-reviewed publications.
She brings working knowledge of ICH-GCP, MedDRA, pharmacovigilance, ADR/AE reporting, clinical data management, and regulatory documentation.
With experience across pharmaceutical R&D, Quality Control, and Quality Assurance, she combines scientific research skills with strong attention to accuracy and detail.
Her background in manuscript development, publication planning, and scientific communication enables her to translate complex healthcare information into clear, reliable content.