Summit Updates Ivonescimab OS Data and US FDA Review Timing

Summit said the overall survival hazard ratio for ivonescimab plus chemotherapy in the HARMONi study fell to 0.76 in the all-treated population and in the Western subgroup, based on data through June 2026. The company said it has submitted the result to the US FDA. Jiemian News reported that the update extends the follow-up period and brings the Western subgroup result in line with the benefit seen in China’s phase 3 study.

HARMONi is a global phase 3 trial of ivonescimab plus chemotherapy as second-line treatment for EGFR-mutated non-small cell lung cancer. In China, Akeso’s HARMONi-A phase 3 trial previously reported statistically positive results on both progression-free survival and overall survival, with PFS HR at 0.46 and OS HR at 0.74. Ivonescimab was first approved in mainland China in May 2024. Summit had previously reported OS HR of 0.79 for the all-treated population and 0.98 for the Western subgroup in an earlier readout, before the latest update lowered both figures to 0.76.

Summit filed the US marketing application for this indication in the fourth quarter of 2025, and the FDA target action date is November 14, 2026. Akeso said 2025 revenue was 3.056 billion yuan, including about 3.033 billion yuan in commercial sales, up 51% year on year, driven mainly by cadonilimab and ivonescimab. The company said ivonescimab has also been approved in mainland China for first-line PD-L1-positive non-small cell lung cancer, while its application for first-line advanced squamous non-small cell lung cancer has been accepted.