Summit Therapeutics announced that its partner, Akeso Inc., reported positive overall survival (OS) results from the Phase III HARMONi-2 study. The trial demonstrated that ivonescimab monotherapy achieved a statistically significant improvement in OS compared to pembrolizumab monotherapy in patients with PD-L1 positive, locally advanced or metastatic non-small cell lung cancer (NSCLC).
Key Details
- Trial: The HARMONi-2 study is a randomized, double-blind Phase III trial conducted in China and sponsored by Akeso.
- Endpoint: The positive result was for the secondary endpoint of Overall Survival (OS). The study's primary endpoint, progression-free survival (PFS), had previously met statistical significance, leading to marketing approval in China.
- Regulatory Status: Ivonescimab (known as SMT112 in Summit's territories) remains investigational and is not approved by any regulatory authority in the United States or Europe. Full results are scheduled to be presented at an upcoming medical conference.