Ivonescimab Approval in China
Ivonescimab received approval from NMPA, the health authority in China, as frontline monotherapy treatment for patients with NSCLC whose tumors have positive PD-L1 expression. This approval is based on positive PFS results from Akeso's HARMONi-2 trial.
Positive Interim Analysis Results
An early interim analysis requested by the NMPA showed a clinically meaningful and strongly positive trend favoring ivonescimab with a hazard ratio of 0.777, implying a potential 22% reduction in the risk of death compared to pembrolizumab.
HARMONi-6 Phase III Trial Success
HARMONi-6 Phase III trial met its primary endpoint of progression-free survival, showing statistically significant and clinically meaningful improvement in PFS for ivonescimab plus chemotherapy against tislelizumab plus chemotherapy in advanced squamous NSCLC.
Expansion of Clinical Trials
Summit has initiated multiple global Phase III studies, including HARMONi-3 and HARMONi-7, evaluating ivonescimab in different settings of NSCLC. Additionally, collaborations with institutions like MD Anderson and Pfizer are expanding research into other cancer types.
Strong Financial Position
Summit ended Q1 2025 with a cash position of approximately $361 million and remains debt-free.