HR 'Significantly Better Than Expected' In Akeso's HARMONi-2 Trial in 1L NSCLC

Head-To-Head Study With Keytruda

Akeso's CEO has highlighted favorable hazard ratio results for the Chinese biotech's anti-PD-1/VEGF bispecific antibody ivonescimab in a head-to-head trial with Keytruda across Chinese NSCLC patients with positive PD-L1 expression in a first-line setting.

speculation
New disclosures heighten discussion of clinical meaningfulness of Akeso's head-to-head trial with Keytruda • Source: Shutterstock

Akeso Inc.’s ivonescimab achieved “significantly better than expected” hazard ratio (HR) results across all PD-L1-positive populations in the China-based HARMONi-2 Phase III trial, which is comparing monotherapy with the anti-PD-1/VEGF bispecific antibody with Merck & Co., Inc.’s Keytruda (pembrolizumab) for the first-line treatment of non-small cell lung cancer (NSCLC) with positive PD-L1 expression (PD-L1 TPS >1%).

Key Takeaways
  • Akeso confirmed on 29 August the hazard ratio was “significantly better than expected” in the ivonescimab group across patients with both PD-L1-low expression and PD-L1-high expression in the HARMONi-2 trial comparing the bispecific antibody with Keytruda.

  • However, baseline characteristics make a cross-trial comparison of PFS benefits challenging

The disclosures, which came from Akeso chairwoman and CEO Michelle Xia during an earnings call for the Chinese firm’s interim results on 29 August, heightened speculation about the clinical meaningfulness of the head-to-head comparison

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