Akeso says ivonescimab met overall survival endpoint in final anlysis

Akeso (AKESF) announced in its first half results yesterday that ivonescimab met the overall survival endpoint in the HARMONi-A final analysis. The company said, “During the reporting period, an interim analysis of the first global multicenter Phase III trial (HARMONi) also demonstrated strongly positive PFS outcomes. Although statistical significance for OS was not yet reached at the time of the announcement, a promising trend toward OS benefit was observed. With 38% of the patients enrolled from regions such as Europe and North America, the intent-to-treat survival outcomes were highly consistent with those from the China-based HARMONi-A study, supporting ivonescimab’s cross-regional consistency in efficacy and safety and enhancing its global market potential. Furthermore, following positive results from HARMONi-2-a randomized, double-blind, head-to-head Phase III trial against pembrolizumab monotherapy that led to its approval in first-line PD-L1-positive NSCLC, ivonescimab plus chemotherapy has now also demonstrated significant positive outcomes in another head-to-head Phase III study against tislelizumab plus chemotherapy in first-line squamous NSCLC. This clinical outcome demonstrates that ivonescimab shows significant clinical breakthroughs, whether compared to PD-1 monotherapy, or compared to PD-1 in combination with chemotherapy, or compared to VEGF-related therapies in the area of anti-angiogenesis. This highlights the remarkable capability of ivonescimab to make leapfrog advancements in cancer treatment.” Shares of Summit Therapeutics (SMMT), Akeso’s U.S. partner on ivonescimab, are trading down 4% to $25.86 in the premarket.