Akeso, Inc. (HKEX: 9926.HK) and its global partner, Summit Therapeutics Inc. (NASDAQ: SMMT), announced positive updated overall survival (OS) data for ivonescimab from the HARMONi Phase III clinical trial. The trial investigated ivonescimab, a PD-1/VEGF bispecific antibody, in combination with chemotherapy for lung cancer.
The updated analysis, presented at the 2025 World Conference on Lung Cancer (WCLC) Presidential Symposium, showed a statistically significant improvement in OS. Specifically, the hazard ratio (HR) was 0.78, with a p-value of 0.0332. This improvement was observed primarily in patients from Western countries, who were followed for an extended period.
This positive result follows earlier findings from HARMONi showing a statistically significant improvement in progression-free survival (PFS). The consistent benefit across both PFS and OS further supports the drug’s efficacy. Additionally, Akeso reported that the HARMONi-A trial, conducted in China, also demonstrated positive OS results.
Jonathan Goldman, MD, a professor of medicine at UCLA, presented the HARMONi data. He highlighted the consistent benefits across various patient subgroups, including those from North America and Europe. The North American subgroup showed a particularly strong HR of 0.70. The initial analysis of OS, while showing a positive trend, did not reach statistical significance due to shorter follow-up times, particularly among Western patients. The extended follow-up addressed this limitation.
The median OS remained consistent with the initial analysis, at 16.8 months for ivonescimab plus chemotherapy versus 14.0 months for the placebo group. However, the extended follow-up provided a more robust statistical assessment.
Ivonescimab‘s positive PFS results were also reinforced by a longer-term follow-up analysis. The analysis showed a consistent, clinically meaningful improvement in PFS across various patient subgroups. This included patients from both Western and Asian populations, regardless of PD-L1 expression levels.
The drug also demonstrated a favorable safety profile. No new safety signals were identified, and the safety data were consistent with those from the HARMONi-A trial.
Akeso is pursuing a dual strategy to maximize the value of ivonescimab globally. This includes accelerating commercialization and label expansion in China while also advancing global development in partnership with Summit Therapeutics. The company plans to submit the data from the HARMONi and HARMONi-A trials to regulatory agencies. Akeso is also conducting multiple additional Phase III trials for ivonescimab across various cancer types. These trials explore its use in various settings, including first-line treatment and treatment after progression on other therapies.
The company’s forward-looking statements include projections about regulatory approvals and commercial success. These are subject to risks and uncertainties.
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