Akeso Says Its Lung Cancer Drug Beat Pembrolizumab on Survival, but Released No Numbers
The Hong Kong-listed drug developer Akeso said on Sept. 2 that its lung-cancer antibody ivonescimab met the overall-survival endpoint of a Phase III trial that tested it against pembrolizumab, and released none of the survival figures behind that result.
Akeso (9926.HK) said the finding came from a pre-specified interim analysis in the HARMONi-2 trial, also identified as AK112-303, and was assessed by the study's Independent Data Monitoring Committee, a group that reviews trial data separately from the sponsor. Overall survival was a key secondary endpoint. The company called the outcome a "statistically significant and clinically meaningful improvement over pembrolizumab." That is Akeso's own characterization; the underlying data has not been published and no independent analysis of it exists.
The release carries no median survival figure for either group, no hazard ratio and no confidence interval. Akeso said detailed data from the interim analysis "will be presented at an upcoming international medical conference and published in a peer-reviewed journal." It named neither the conference nor a date.
HARMONi-2 is a randomized, double-blind, multicenter Phase III trial in patients with locally advanced or metastatic non-small cell lung cancer whose tumors test positive for the protein PD-L1, at a threshold of 1% or more, according to the release. Ivonescimab is a bispecific antibody, a single molecule built to hit two targets at once, in this case PD-1 and VEGF.
The trial has reported once before. Akeso said that in May 2024 the same committee found HARMONi-2 had met its primary endpoint, progression-free survival, with a median of 11.14 months for ivonescimab against 5.82 months for pembrolizumab.
Yu Xia, Akeso's founder and chief executive, said in the release that the results "further reinforce the clinical value of ivonescimab in the treatment of lung cancer."
Akeso said the same indication was approved by regulators in China in 2025, and that the approval provided a treatment option without chemotherapy.
