"Innovent's Lung Cancer Drug Trial Shows Positive Results, Shares Jump 14%

Innovent Biologics' Phase 1 trial for its lung cancer drug has shown manageable safety and long-term survival benefits. The trial results have led to a 14% surge in the company's shares. The drug, which is still under development, has the potential to become a significant addition to the company's product portfolio.

Innovent Biologics, Inc. (HKEX: 01801) has presented encouraging results from its Phase 1 trial of IBI363, a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein, at the 2025 American Society of Clinical Oncology (ASCO) meeting. The trial, conducted in advanced non-small cell lung cancer (NSCLC), demonstrated manageable safety and long-term survival benefits, leading to a 14% surge in the company's shares.

The Phase 1 trial, which included 136 patients with NSCLC, showed that IBI363 achieved a median overall survival (OS) of 15.3 months in the 1 mg/kg Q2W and 1.5 mg/kg Q3W dose groups, and a median OS not reached in the 3 mg/kg Q3W dose group. The trial also reported encouraging overall response rates (ORR) and disease control rates (DCR) across different dose groups, with the highest dose group showing a confirmed ORR of 36.7% and a DCR of 90.0%.

The drug demonstrated promising efficacy in both immunotherapy-resistant squamous NSCLC and wild-type lung adenocarcinoma. In squamous NSCLC, the 3 mg/kg dose group showed a median progression-free survival (PFS) of 9.3 months and a 12-month OS rate of 70.9%. In wild-type lung adenocarcinoma, the 3 mg/kg dose group showed a median PFS of 5.6 months and a 12-month OS rate of 71.6%. The trial also found that IBI363 showed potential advantages in patients with low expression of PD-L1 and those with a history of smoking.

Innovent Biologics has received Breakthrough Therapy (BTD) certification from China CDE and Fast Track Designation (FTD) from the US FDA for squamous NSCLC, indicating the potential of IBI363 as a significant addition to the company's product portfolio. The company plans to conduct a Phase 3 registration clinical study in locally advanced or metastatic squamous NSCLC that has failed platinum-based chemotherapy and anti-PD-1/PD-L1 immunotherapy.

The results of the Phase 1 trial have led to a 14% surge in Innovent Biologics' shares, reflecting the market's optimism about the drug's potential. The company's senior vice president, Dr. Hui Zhou, stated that the trial results suggest better trends in ORR, DCR, PFS, and OS at higher doses and that the drug may bring long-term survival benefits to patients.

References:

[1] https://www.biospace.com/press-releases/2025-asco-oral-presentation-innovent-biologics-announces-updated-data-of-ibi363-first-in-class-pd-1-il-2%CE%B1-bias-bispecific-antibody-fusion-protein-from-the-phase-1-poc-clinical-study-in-advanced-non-small-cell-lung-cancer