Ivonescimab Plus Chemotherapy Demonstrates Consistent Global Benefit: HARMONi Data Update Shows OS HR=0.78, Nominal P=0.0332

Core Insights - Akeso, Inc. announced positive overall survival (OS) results from the Phase III HARMONi clinical trial of ivonescimab, a PD-1/VEGF bispecific antibody, presented at the World Conference on Lung Cancer [1][2] - The trial demonstrated consistent clinical efficacy in both progression-free survival (PFS) and OS across diverse populations, reinforcing ivonescimab's potential as a significant cancer treatment [3][7] Overall Survival Results - The updated OS results showed a hazard ratio (HR) of 0.78 with a nominal p-value of 0.0332, indicating a favorable trend in OS for western patients [2][6] - Median OS for patients receiving ivonescimab was 17.0 months compared to 14.0 months for those on placebo, with North American patients showing an HR of 0.70 [6][7] Progression-Free Survival Results - Ivonescimab demonstrated a statistically significant improvement in PFS with an HR of 0.52 in the primary analysis, and a longer-term follow-up showed an HR of 0.57 [8][9] - Median PFS was reported as 6.8 months for ivonescimab versus 4.4 months for placebo in the primary analysis [8] Clinical Efficacy and Safety - The overall response rate was higher in the ivonescimab arm at 45% compared to 34% in the placebo arm, with a median duration of response of 7.6 months versus 4.2 months [10] - Ivonescimab exhibited a favorable safety profile with no new safety signals identified, consistent with previous trials [10] Strategic Development and Future Trials - Akeso is pursuing a dual-path strategy to enhance ivonescimab's value through domestic commercialization in China and global development in partnership with Summit Therapeutics [15] - The company has an extensive development program with multiple Phase III trials targeting various cancer types, including first-line treatments for NSCLC and other indications [12][19] Mechanism of Action - Ivonescimab uniquely targets both PD-1 and VEGF, providing a synergistic anti-tumor effect that overcomes limitations of each target alone, establishing it as a leader in immunotherapy [14]