On August 26, AKESO rose 6.64% in regular trading, trading at HK$93.7 per share, with turnover of HK$152 million.
The move was driven by the company's announcement that its pivotal Phase III clinical trial HARMONi-GI1 (AK112-309) achieved its primary endpoint of overall survival (OS) with statistically significant and clinically meaningful benefit. The study evaluated ivonescimab, the company's first-in-class PD-1/VEGF bispecific antibody, combined with chemotherapy versus durvalumab plus chemotherapy as first-line treatment for advanced biliary tract cancer. The trial enrolled 682 subjects and also met all key secondary endpoints including progression-free survival and objective response rate. This represents the first Phase III study to demonstrate significant OS superiority over the current global standard of care in biliary tract cancer.
This milestone adds to recent momentum including the approval of ivonescimab's third indication for first-line squamous NSCLC on August 12, with the company's interim results scheduled for release on August 27.
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