SAN FRANCISCO and SUZHOU, China, May 21, 2026
Innovent Biologics, Inc. announced updated long-term clinical data from the Phase I proof-of-concept (PoC) study of IBI363, its first-in-class PD-1/IL-2α-bias bispecific fusion protein, demonstrating significant survival benefits in patients with advanced immunotherapy-resistant non-small cell lung cancer (NSCLC). The updated results will be presented during the ASCO Annual Meeting 2026 in Chicago and further strengthen the company’s position in next-generation cancer immunotherapy. The findings showed that IBI363 delivered durable overall survival benefits, prolonged progression-free survival, and a manageable long-term safety profile in heavily pretreated NSCLC patients who had previously failed immunotherapy.
IBI363 Demonstrates Durable Survival in Resistant NSCLC
The updated analysis included 136 patients with advanced NSCLC treated with IBI363 monotherapy across multiple dose cohorts. The study focused on patients with immunotherapy-resistant squamous and adenocarcinoma NSCLC, a population with extremely limited treatment options and historically poor survival outcomes after progression on checkpoint inhibitors.
Among patients with squamous NSCLC, the most promising results were observed in the 3 mg/kg Q3W dose group, where the median progression-free survival (PFS) reached 10.1 months and the median overall survival (OS) achieved 18.2 months. The study also reported a 24-month overall survival rate of 47.8%, highlighting what investigators described as a strong “long-tail survival effect.” These outcomes compare favorably with historical standard-of-care docetaxel data from the TROPION-Lung01 study, where median overall survival was approximately 9.4 months.
In patients with EGFR wild-type adenocarcinoma NSCLC, IBI363 also showed meaningful long-term benefits. The 3 mg/kg cohort achieved a median OS of 15.2 months with a 24-month survival rate of 42.7%. Notably, patients with a smoking history experienced even greater survival improvements, with median overall survival extending to 23.4 months across all dose groups. Investigators believe smoking history may influence responsiveness to the drug’s immune-activating mechanism.
Dual Mechanism Drives Competitive Clinical Activity
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IBI363 is designed as a bispecific fusion protein combining PD-1 immune checkpoint blockade with selective IL-2 pathway activation. Unlike traditional IL-2 therapies associated with severe toxicity, IBI363 uses an IL-2α-bias design that maintains affinity for IL-2Rα while reducing interaction with IL-2Rβ and IL-2Rγ receptors, potentially minimizing systemic side effects.
The therapy simultaneously blocks the PD-1/PD-L1 pathway while selectively delivering IL-2 stimulation within the tumor microenvironment. Innovent believes this dual mechanism enhances anti-tumor immune activity and contributes to the durable responses and prolonged survival observed in long-term follow-up.
Safety data from the study remained favorable and manageable. Grade 3 or higher treatment-emergent adverse events occurred in 48.5% of patients. The most common side effects included arthralgia, anemia, and rash, most of which were mild to moderate and manageable with supportive care. Importantly, no new long-term safety signals were identified during extended follow-up.
Global Phase III Development Expands After Positive Results
Based on the encouraging data, Innovent has already initiated the global Phase III MarsLight-11 study evaluating IBI363 in immunotherapy-resistant squamous NSCLC. The company also plans to launch a separate global Phase III study for non-squamous NSCLC pending regulatory discussions.
IBI363 has received multiple regulatory recognitions, including two Fast Track Designations from the U.S. FDA and three Breakthrough Therapy Designations from China’s NMPA. In 2025, Innovent entered a major global collaboration agreement with Takeda Pharmaceutical Company for co-development and commercialization of the therapy.
The ASCO 2026 presentation positions IBI363 as one of the most closely watched emerging immunotherapy candidates for patients with resistant lung cancer, an area with substantial unmet medical need and limited effective treatment options.
Source: Innovent Biologics press release
