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

Head-To-Head Study With Keytruda

 
• By Dexter Jie Yan

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.

The disclosures, which came from Akeso chairwoman and CEO Michelle Xia during an earnings call for the Chinese firm’s interim...

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