Innovent Biologics, Inc. (IVBXF,1801.HK), a biopharmaceutical company, announced a positive result and updated data from the Phase 1 proof-of-concept or PoC clinical study of IBI363 for the treatment of advanced immunotherapy (IO)-resistant non-small cell lung cancer (NSCLC).
IBI363 or PD-1/IL-2a bias bispecific fusion protein, which selectively activates the IL-2 pathway and blocks programmed cell death protein 1 or PD-1 and programmed death-ligand 1 or PD-L1 pathway. Innovent and Takeda are co-developing IBI363.
The drug has received two fast track designations or FTD from the U.S. FDA and three breakthrough therapy designations or BTD from the China National Medical Products Administration (NMPA).
Key Highlights
As of the cut-off date, November 20, 2025, a total of 136 subjects with NSCLC participated in the PoC study and received IBI363 monotherapy (2 µg/kg QW; 4mg/kg Q3W). Subgroup analyses included 67 patients with squamous NSCLC and 58 patients with EGFR wild-type adenocarcinoma NSCLC.
In 67 patients with squamous NSCLC, 28 patients received IBI363 at 1 mg/kg Q2W or 1.5 mg/kg Q3W, and 31 patients received 3 mg/kg Q3W.
Among patients who received the 3 mg/kg Q3W dose, the median progression-free survival (PFS) was 10.1 months, and the median Overall Survival or OS was 18.2 months, with a 24-month OS rate of 47.8%.
All 67 squamous NSCLC patients had no known EGFR mutations and IBI363 reported robust survival benefits with a long-term effect in IO-Resistant Squamous NSCLC.
And in IO-Resistant EGFR Wild-type AdenoNSCLC, the drug showed potential for long-term survival benefits. A total of 58 patients participated, among whom 30 received IBI363 at 0.6 mg/kg Q2W, 1 mg/kg Q2W, or 1.5 mg/kg Q3W, and 25 received 3 mg/kg Q3W.
The study showed that in the 3mg/kg dose group, the median PFS reached 4.2 months. The median OS was 15.2 months, with a 24-month OS rate of 42.7%.
Notably, adenoNSCLC patients with a smoking history reported better survival benefits; the median OS for smokers across all dose groups (N=31) reached 23.4 months.
IBI363 showed a manageable and generally favourable safety profile in its long-term follow-up of the overall population (n=136).
The updated data from the Phase 1 PoC of IBI363 were presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting on May 31, 2026.
IVBXF closed Monday's stock at HK$ 81.05, down 2.76% on the Hong Kong Stock Exchange
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