Hong Kong – September 07, 2026 -- Akeso, Inc. (9926.HK) said its bispecific antibody ivonescimab produced a statistically significant and clinically meaningful overall survival benefit versus Merck's pembrolizumab in a pre-specified interim analysis of the Phase III HARMONi-2 trial, as assessed by an Independent Data Monitoring Committee.
Ivonescimab clears key secondary survival endpoint against Keytruda
The HARMONi-2 (AK112-303) study is a randomized, double-blind, multicenter registrational trial testing ivonescimab against pembrolizumab as first-line therapy in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 at a TPS of 1% or higher. Detailed interim overall survival data will be presented at an upcoming international medical conference and published in a peer-reviewed journal.
Drug already beat pembrolizumab on progression-free survival in May 2024
At an earlier interim analysis in May 2024, ivonescimab met the trial's primary endpoint of progression-free survival, posting a median PFS of 11.14 months versus 5.82 months for pembrolizumab. Akeso said HARMONi-2 is the first randomized, double-blind Phase III trial to record a significant positive outcome against pembrolizumab in this treatment setting.
China approval in 2025 lifted restrictions on VEGF-targeted agents
The NSCLC indication for ivonescimab received regulatory approval in China in 2025, removing prior restrictions on VEGF-targeted agents for patients with squamous histology and establishing a chemotherapy-free treatment option now in clinical use.
Dr. Yu Xia, Founder, Chairwoman, President and CEO of Akeso, said the HARMONi-2 result marks the fourth Phase III study of an ivonescimab-based regimen to show statistically significant benefit in both overall survival and progression-free survival. "This growing body of evidence strengthens our confidence in its potential across a broader range of solid tumors,