Innovent Biologics announced IBI363 trial results on October 26, 2026, reporting activity across three Phase 1b studies in lung and gastric cancers at the European Society for Medical Oncology Congress. The clearest comparative finding came from immunotherapy-resistant lung adenocarcinoma, where IBI363 plus bevacizumab reduced the risk of disease progression or death versus docetaxel. The investigational medicine, also called TAK-928, is being developed with Takeda; the early findings do not yet establish an overall survival benefit.
Key Takeaways
- IBI363 plus bevacizumab reduced the risk of progression or death by 60% versus docetaxel in a randomized Phase 1b lung cancer study.
- Two first-line chemotherapy combination studies reported tumor responses in lung and gastric cancers, but survival findings remain immature.
- A global Phase 3 monotherapy study is underway, while a randomized first-line gastric cancer study is planned.
Table of Contents
- IBI363 trial results include a randomized lung cancer benefit
- First-line lung study explores dosing with chemotherapy
- Gastric cancer responses warrant controlled follow-up
- Takeda partnership supports broader development
- Conclusion
IBI363 trial results include a randomized lung cancer benefit
The randomized study enrolled patients with locally advanced, unresectable or metastatic lung adenocarcinoma whose cancer had progressed after immunotherapy and lacked actionable genomic alterations. It compared IBI363 plus bevacizumab with the chemotherapy docetaxel.
The progression-free survival hazard ratio was 0.40, corresponding to a 60% reduction in the risk of progression or death, with a p-value of 0.0006. Confirmed objective response rates—the proportion of patients with confirmed tumor shrinkage—were 20.0% with the combination and 7.1% with docetaxel.
Overall survival data remained immature. Although baseline characteristics were generally balanced, the docetaxel group included higher proportions of patients with a smoking history and PD-L1 expression of at least 1%. The Phase 1b finding supports further testing rather than establishing a definitive survival advantage.
Grade 3 or higher treatment-emergent adverse events occurred in 62.2% of patients receiving the combination and 78.0% receiving docetaxel. There were no treatment-related deaths in the combination group and one in the docetaxel group.
| Item | Details |
|---|---|
| First-line lung cancer | April 7, 2026 cutoff; median follow-up of 8.9 months. |
| First-line gastric or gastroesophageal junction cancer | July 9, 2026 cutoff; median follow-up of 9.2 months. |
| Immunotherapy-resistant lung adenocarcinoma | July 6, 2026 cutoff; median follow-up of 8.48 months for IBI363 plus bevacizumab and 7.59 months for docetaxel. |
First-line lung study explores dosing with chemotherapy
A separate study evaluated IBI363 with platinum-based doublet chemotherapy in 80 patients with previously untreated locally advanced or metastatic non-small cell lung cancer. Of these, 69 entered a dose-optimization phase restricted to patients with PD-L1 tumor proportion scores below 50%.
Confirmed response rates were 47.4%, 61.9% and 86.4% in the 1.5 mg/kg, 3 mg/kg and 3-to-1.5 mg/kg dose groups, respectively. These comparisons were between dosing strategies, not against a standard-treatment control arm, and progression-free survival data remained immature.
Innovent reported no new safety signals with longer follow-up. Common treatment-emergent adverse events included anemia in 82.5% of patients and decreased neutrophil counts in 76.3%. The randomized controlled phase of the study is progressing.
Gastric cancer responses warrant controlled follow-up
The investigator-initiated gastric cancer study enrolled 46 patients with HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma. It tested IBI363 with capecitabine and oxaliplatin, a chemotherapy combination known as XELOX, as initial treatment.
Among 42 patients with at least one post-baseline tumor assessment, the confirmed response rate was 78.6% and the disease control rate was 100.0%. In the 35-patient response-evaluable expansion cohort receiving 1.5 mg/kg, those rates were 80.0% and 100.0%, respectively.
The estimated 12-month progression-free and overall survival rates in the overall response-evaluable population were 52.8% and 84.5%. Survival data remained immature, and follow-up is ongoing.
Grade 3 or higher treatment-emergent adverse events occurred in 45.7% of the overall enrolled population. No treatment-related deaths were reported. Innovent plans a randomized controlled proof-of-concept study to further evaluate the combination.
Takeda partnership supports broader development
The companies’ October 2025 oncology partnership agreement established global co-development of IBI363, with Takeda bearing 60% of development costs and Innovent 40%. It also provides for U.S. co-commercialization and exclusive Takeda commercialization rights outside the U.S. and Greater China.
IBI363 is designed to block the PD-1/PD-L1 pathway while selectively activating the IL-2 pathway. The current updates test different combinations and treatment settings; their response rates should not be treated as directly comparable.
Innovent said the global Phase 3 MarsLight-11 study is already evaluating IBI363 monotherapy in immunotherapy-resistant non-small cell lung cancer. That trial is distinct from the Phase 1b bevacizumab combination study presented at ESMO.
Conclusion
The IBI363 trial results provide early evidence across several cancer settings, with the randomized resistant-lung-cancer study offering the strongest comparative signal. Ongoing survival follow-up, the progressing controlled first-line lung study and the Phase 3 monotherapy program are the next evidence milestones to watch; the gastric cancer controlled study remains planned.
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