Akeso says ivonescimab improves overall survival versus pembrolizumab in Phase III trial

  • Akeso reported that ivonescimab met HARMONi-2’s interim overall-survival endpoint against pembrolizumab.
  • 0.51 was ivonescimab’s progression-free-survival hazard ratio, with a 95% confidence interval of 0.38 to 0.69.
  • China approved ivonescimab for NSCLC in April 2025, while Summit’s territories remain investigational.

Akeso said a prespecified interim analysis of overall survival in the China-only HARMONi-2 Phase III trial showed ivonescimab delivered a statistically significant improvement over pembrolizumab in patients with locally advanced or metastatic PD-L1-positive non-small cell lung cancer. Summit Therapeutics shares rose more than 12% after the announcement because Summit holds rights to develop ivonescimab, known as SMT112 in its territories and AK112 elsewhere. The trial had already met its primary progression-free survival endpoint, with a hazard ratio of 0.51 and a 95% confidence interval of 0.38 to 0.69. Ivonescimab is a bispecific antibody targeting PD-1 and VEGF. China approved the drug for NSCLC in April 2025, while it remains investigational in Summit's licensed territories. Full survival results are due at an upcoming medical conference, with Summit's global Phase 3 program and a November 14, 2026, FDA decision on the HARMONi application among the key developments for investors.

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