Akeso Reports Positive Phase III Results for Ivonescimab in Lung Cancer

Akeso announced positive results from its Phase III HARMONi-6 clinical trial evaluating ivonescimab in combination with chemotherapy for advanced squamous non-small cell lung cancer (sq-NSCLC), according to a press release. The data were presented at the 2025 Presidential Symposium of the ESMO Congress and published in The Lancet.

The study met its primary endpoint of progression-free survival (PFS), with ivonescimab plus chemotherapy achieving a median PFS of 11.14 months compared to 6.90 months for tislelizumab plus chemotherapy. The hazard ratio for PFS was 0.60 (p < 0.0001), representing an improvement of 4.24 months.

Clinical benefits were consistent across patient subgroups, including those with varying PD-L1 expression levels and with or without liver or brain metastases. Among patients with liver metastases, the PFS hazard ratio was 0.53, while those without liver metastases had a hazard ratio of 0.64.

The safety profile of the ivonescimab combination was favorable, with no new safety signals identified and a comparable incidence of serious adverse reactions to the tislelizumab regimen. Overall survival data were not yet mature at the time of analysis. Akeso has submitted a supplemental New Drug Application in China for the regimen as a first-line treatment for advanced sq-NSCLC, while global enrollment continues for the HARMONi-3 trial in both squamous and non-squamous NSCLC.