Akeso's Ivonescimab Shows Consistent Clinical Efficacy in Phase III Trials, Demonstrates Survival Benefits to Cancer Patients

Strategic Insights -

Akeso's global partner, Summit Therapeutics, has announced updated overall survival (OS) results from the global Phase III HARMONi clinical trial of ivonescimab, a novel PD-1/VEGF bispecific antibody. The results demonstrate a consistent and robust clinical efficacy in both progression-free survival (PFS) and OS across diverse global populations. Ivonescimab, in combination with chemotherapy, has shown a statistically significant and clinically meaningful improvement in PFS, with a hazard ratio of 0.52 (95% CI: 0.41 -- 0.66; p=0.001) in a prespecified primary data analysis. The trial results were presented by Jonathan Goldman, MD, Professor of Medicine at UCLA in the Hematology/Oncology Division, UCLA Director of Clinical Trials in Thoracic Oncology, Associate Director of Early Drug Development, and Chair of University of California Lung Cancer Consortium.

Key Takeaways:

  • Ivonescimab in combination with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in PFS with a hazard ratio of 0.52 (95% CI: 0.41 -- 0.66; p=0.001) in the primary analysis.
  • The OS hazard ratio in the HARMONi trial was 0.78, with a nominal p-value of 0.0332, indicating a consistent and robust clinical efficacy in both PFS and OS across diverse global populations.
  • Ivonescimab has shown positive results in the HARMONi-2 trial, a randomized, double-blind, head-to-head Phase III study against pembrolizumab monotherapy, which led to its approval for first-line treatment of PD-L1-positive NSCLC.
  • Recently, Akeso announced that the HARMONi-A study conducted in China has also reached the OS clinical endpoint, achieving clinically meaningful and statistically significant OS benefit.
  • The results from the first international multi-center Phase III HARMONi study of ivonescimab, along with those from the Phase III HARMONi-A study conducted in China, demonstrated consistent and robust clinical efficacy in both progression-free survival (PFS) and OS.
  • Approximately 38% of patients were recruited from western countries.

Statistics:

  • Hazard Ratio: 0.78 (95% CI: 0.62 -- 0.98; nominal p=0.0332)
  • Median OS for western patients: 17.0 months
  • Median OS in North American patients: 14.0 months (HR=0.70)
  • Hazard Ratio for western patients: 0.84
  • Overall response rates: 45% in the ivonescimab arm vs. 34% in the placebo arm
  • Median duration of response: 7.6 months in the ivonescimab arm vs. 4.2 months in the placebo arm

Sources:

  • Akeso, Inc.
  • Summit Therapeutics Inc.
  • World Conference on Lung Cancer (WCLC)
  • University of California Lung Cancer Consortium
  • Akeso website
  • Contify.com