Akeso Reports Positive Overall Survival Results for Ivonescimab in NSCLC Study
News related to:Akeso, Inc · 2 min read
HONG KONG, Sept. 13, 2026 /CourierPR/ -- Akeso, Inc., a leading biopharmaceutical company, announced positive overall survival (OS) results from its Phase III HARMONi-2 study at the 2026 World Conference on Lung Cancer (WCLC). The study evaluated the company’s first-in-class next-generation immuno-oncology therapy, ivonescimab, against pembrolizumab as a first-line treatment for patients with PD-L1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).
The HARMONi-2 study, a randomized, double-blind, multicenter, registrational trial, showed that ivonescimab significantly prolonged OS compared to pembrolizumab. According to the data, the median OS for patients treated with ivonescimab was 30.8 months, a 27% reduction in the risk of death compared to the 22.6 months seen in the pembrolizumab group. This finding met the prespecified statistical significance threshold and demonstrated clear clinical benefit.
The results were particularly pronounced in the PD-L1-high population, with a 42% reduction in the risk of death. The study also showed consistent OS benefits regardless of the histology of the tumor, with a 35% reduction in the risk of death for squamous cell carcinoma patients and a 21% reduction for non-squamous patients.
Professor Caicun Zhou, the principal investigator of HARMONi-2 and the Director of the Department of Oncology at Shanghai East Hospital, will present the complete results at the WCLC on September 15, 2026.
Ivonescimab's favorable overall safety profile was also highlighted. The study did not observe a significant increase in bleeding risk among high-risk squamous patients, a population traditionally considered contraindicated or high-risk for anti-VEGF therapies. This finding is particularly significant as it opens up a broader range of treatment options for these patients.
The HARMONi-2 study is the first randomized, double-blind, controlled Phase III clinical trial to demonstrate statistically significant positive OS and progression-free survival (PFS) results against pembrolizumab. This achievement underscores Akeso's commitment to developing innovative biological medicines that provide better disease solutions for patients.
Akeso, founded in 2012, has built a comprehensive R&D innovation ecosystem anchored by its proprietary Tetrabody antibody technology platform, AI-powered drug R&D platform, Dual-Shield ADC technology platform, Dual-Lock T-cell engager (TCE) technology platform, Tissue-Smart siRNA/mRNA technology platform, and cell therapy technology platforms. The company's robust pipeline includes more than 50 innovative assets targeting cancer, autoimmune diseases, inflammation, metabolic disorders, and other major therapeutic areas.
The positive results from the HARMONi-2 study are expected to drive continued progress in oncology care and potentially expand the treatment options available for patients with NSCLC. Akeso's next steps include an international multicenter Phase III clinical study evaluating ivonescimab monotherapy versus pembrolizumab as first-line treatment for PD-L1-high NSCLC (HARMONi-7/AK112-3007).