Suzhou, China, and San Francisco, California, USA, October 26, 2026
Innovent Biologics has announced new clinical data for IBI363 (TAK-928), an investigational PD-1/IL-2α-biased bispecific fusion protein being jointly developed with Takeda. Presented at the 2026 European Society for Medical Oncology (ESMO) Congress in Madrid, Spain, the findings cover three Phase 1b studies evaluating the therapy in first-line non-small cell lung cancer (NSCLC), first-line gastric or gastroesophageal junction adenocarcinoma (G/GEJA), and lung adenocarcinoma that progressed following immunotherapy. The results highlight the potential of IBI363 to combine immune checkpoint inhibition with selective interleukin-2 signaling to stimulate antitumor activity across different cancer settings. In a study of previously treated, immunotherapy-resistant lung adenocarcinoma, IBI363 plus bevacizumab reduced the risk of disease progression or death by 60% compared with docetaxel, while the first-line gastric cancer study reported an objective response rate of 78.6% among evaluable patients. These early findings support continued investigation of the treatment, although larger controlled trials and longer follow-up are needed to establish its clinical benefit.
IBI363 Shows Activity in First-Line Gastric Cancer
The investigator-initiated Phase 1b study evaluated IBI363 combined with XELOX chemotherapy, consisting of capecitabine and oxaliplatin, as first-line treatment for patients with HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma. As of July 9, 2026, 46 patients had enrolled, including 39 in the dose-expansion phase. Among 42 patients who had undergone at least one post-baseline tumor assessment, the confirmed objective response rate was 78.6%, and the disease control rate reached 100%. In the dose-expansion group receiving IBI363 at 1.5 mg/kg, the objective response rate was 80.0% among 35 patients. Response rates were 90.0% in patients with a PD-L1 combined positive score (CPS) of at least five and 76.9% in those with a CPS below five. The reported 12-month progression-free survival and overall survival rates in the overall evaluable population were 52.8% and 84.5%, respectively, although survival data remain immature. Grade 3 or higher treatment-emergent adverse events occurred in 45.7% of the overall population, with no treatment-related deaths reported. The results provide an encouraging early signal across different PD-L1 expression levels, and a randomized proof-of-concept study is planned to evaluate the combination further.
Combination Therapy Evaluated in Lung Cancer
In a separate Phase 1b study, researchers evaluated IBI363 with platinum-based doublet chemotherapy in patients receiving first-line treatment for advanced NSCLC with PD-L1 tumor proportion scores below 50%. The updated findings showed continued antitumor activity, with disease control rates of 94.7% in the first-line NSCLC study. The data also showed a manageable safety profile, with no new safety signals identified during longer follow-up. The most frequently reported treatment-emergent adverse events included anemia, decreased neutrophil counts, decreased white blood cell counts and decreased platelet counts, consistent with the known toxicities of the treatment components. A randomized controlled study comparing IBI363 plus chemotherapy with pembrolizumab plus chemotherapy is ongoing to better establish its potential role in first-line treatment. In another Phase 1b study, investigators compared IBI363 plus bevacizumab with docetaxel in patients with locally advanced or metastatic lung adenocarcinoma without actionable genomic alterations whose disease had progressed following immunotherapy. The combination achieved a confirmed objective response rate of 20.0%, compared with 7.1% for docetaxel. Median progression-free survival was significantly improved, with a hazard ratio of 0.40, corresponding to a 60% reduction in the risk of progression or death. Overall survival data remain immature, and additional follow-up is ongoing.
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Dual Mechanism Supports Further Clinical Development
IBI363 is designed to combine PD-1 immune checkpoint blockade with alpha-biased IL-2 receptor signaling. Its PD-1-targeting component blocks inhibitory signaling that can limit immune responses against tumors, while its engineered IL-2 component is intended to stimulate antitumor immune cells while reducing unwanted activation associated with broader IL-2 signaling. This approach aims to improve the balance between immune activity and treatment tolerability. Innovent and Takeda are advancing IBI363 through clinical programs spanning multiple tumor types, including lung cancer and colorectal cancer, with additional studies investigating other treatment settings. The companies are also evaluating whether the therapy can provide benefit for patients whose cancers have become resistant to existing immunotherapies. IBI363 remains investigational and is not an approved medicine. The Phase 1b findings are encouraging but cannot establish superiority over standard treatment across all patient populations. Ongoing randomized studies will be essential to confirm efficacy, characterize long-term safety and identify patients most likely to benefit. The latest ESMO results nevertheless reinforce interest in next-generation immunotherapies designed to activate complementary immune pathways and expand treatment options for people with advanced cancers.
Source: Innovent Biologics press release
