Innovent Biologics (HKEX: 01801) announced updated data from its Phase 1 study of IBI363, showing the drug achieved a median overall survival of 18.2 months in patients with advanced immunotherapy-resistant squamous non-small cell lung cancer (NSCLC). The results, presented at the 2026 ASCO Annual Meeting, suggest a significant survival advantage over the current standard of care.
"With longer follow-up, we are encouraged to see outstanding survival outcomes with IBI363 in IO-resistant NSCLC across both squamous and adenoNSCLC," Dr. Hui Zhou, Chief R&D Officer of Innovent, said. "We hope it will offer a new treatment option for this large patient population and ultimately deliver long-term survival benefits."
The updated proof-of-concept data comes from a study of 136 NSCLC patients who had failed prior immunotherapy. In the 3 mg/kg dose group for squamous NSCLC, the median overall survival of 18.2 months and 24-month OS rate of 47.8% compares favorably to historical data for the standard-of-care chemotherapy docetaxel, which showed a 9.4-month median OS and a 14.8% 24-month OS rate in a similar patient population in the TROPION-Lung01 study.
The results position IBI363 as a highly competitive potential therapy in a setting with limited options, where survival is typically less than one year. Based on the data, Innovent has initiated a global Phase 3 trial, MarsLight-11, for IO-resistant squamous NSCLC and plans another for non-squamous NSCLC.
Robust Survival in Squamous NSCLC
The study enrolled 67 patients with squamous NSCLC with no known EGFR mutations. Within this group, 31 patients received what is now the focus dose of 3 mg/kg every three weeks. This cohort saw a median progression-free survival (PFS) of 10.1 months and the median overall survival of 18.2 months. The survival benefit showed a durable "tailing effect," with nearly half of the patients still alive at the two-year mark.
Promise in AdenoNSCLC, Especially Smokers
In the 58 patients with EGFR wild-type adenocarcinoma NSCLC, the 3 mg/kg dose group (25 patients) achieved a median OS of 15.2 months and a 24-month OS rate of 42.7%. This again represents a substantial improvement over the 12.3-month median OS and 21.7% 24-month OS rate seen with docetaxel in non-squamous patients in the TROPION-Lung01 trial.
Notably, smoking history appeared to be a positive predictor of response. Across all dose groups, the 31 adenoNSCLC patients with a history of smoking experienced a median overall survival of 23.4 months.
Favorable Long-Term Safety
IBI363, a first-in-class PD-1/IL-2α-bias bispecific fusion protein, continued to demonstrate a manageable safety profile with extended follow-up. Treatment-emergent adverse events (TEAEs) of grade 3 or higher occurred in 48.5% of the 136 total patients. The most common side effects were arthralgia, anemia, and rash, which were mostly mild-to-moderate and controllable. No new safety concerns were identified.
The drug is co-developed with Takeda, which holds rights outside the U.S. and greater China. The positive data adds to a busy news cycle for Innovent, which also recently gained approval in China for the combination of its PD-1 inhibitor sintilimab (TYVYT) with fruquintinib for advanced renal cell carcinoma, a drug co-developed with HUTCHMED. The lung cancer space is also seeing rapid development from competitors like Kelun-Biotech, which presented positive Phase 3 data for its TROP2 ADC combined with pembrolizumab in first-line NSCLC at the same ASCO meeting.
This article is for informational purposes only and does not constitute investment advice.
