Summit Therapeutics' Lung Cancer Therapy Ivonescimab Shows Improved Progression-Free Survival Versus Merck's Multi-Billion Keytruda In China Study

On Friday, Summit Therapeutics Inc SMMT shares are trading lower after the company’s stock closed 272.1% higher at $10.92 on Thursday.

Thursday, Summit Therapeutics Inc SMMT announced that Phase 3 HARMONi-2, or AK112-303, met its primary endpoint of progression-free survival (PFS).

HARMONi-2 evaluated monotherapy ivonescimab against monotherapy pembrolizumab in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have positive PD-L1 expression (PD-L1 TPS >1%).

The HARMONi-2 is a single-region, multi-center, double-blinded Phase 3 study conducted in China sponsored by Akeso Inc. with data generated and analyzed by Akeso.

At a prespecified interim analysis conducted by an independent Data Monitoring Committee, ivonescimab demonstrated a statistically significant and clinically meaningful improvement in PFS by the blinded independent central radiology review committee (BICR) compared to Merck & Co Inc’s MRK Keytruda (pembrolizumab).

The progression-free survival (PFS) benefit was demonstrated across clinical subgroups, including those with PD-L1 low expression, PD-L1 high expression, squamous and non-squamous histologies, and other high-risk patients.

There are no known Phase 3 clinical trials in NSCLC that have shown a statistically significant improvement compared to pembrolizumab in a head-to-head setting.

Price Action: SMMT shares are down 28.60% at $7.80 at last check on Friday.