Ivonescimab Approval in China
Ivonescimab received approval from the NMPA in China as a frontline monotherapy treatment for NSCLC patients with positive PD-L1 expression. This approval was based on positive progression-free survival (PFS) results from Akeso's HARMONi-2 trial, marking a significant regulatory milestone.
Positive Interim Analysis Results
An interim analysis of overall survival (OS) from the HARMONi-2 trial showed a clinically meaningful and strongly positive trend favoring ivonescimab with a hazard ratio of 0.777, indicating a potential 22% reduction in the risk of death compared to pembrolizumab.
HARMONi-6 Phase III Trial Success
Akeso's HARMONi-6 Phase III trial met its primary endpoint of progression-free survival in patients with advanced squamous NSCLC. The trial showed statistically significant improvement with ivonescimab plus chemotherapy versus tislelizumab plus chemotherapy.
Financial Position
The company ended the first quarter of 2025 with a strong cash position of approximately $361 million and is debt-free after paying off all debt in the fourth quarter of 2024.