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From: Julius Wong	9/9/2024 8:08:29 AM
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Summit stock soars as lung cancer drug beats Merck’s Keytruda in late-stage trial Sep. 09, 2024 7:40 AM ET By: Preeti Singh, SA News Editor da-kuk Summit Therapeutics (NASDAQ: SMMT) shares soar 51% after its investigational bispecific antibody, ivonescimab, reduced the risk of disease progression or death by 49% compared to Merck’s (NYSE: MRK) blockbuster cancer therapy Keytruda (pembrolizumab) in the first-line treatment of lung cancer patients. Shares of Merck ( MRK) fell 5% premarket in response. Conducted in China and sponsored by collaboration partner Akeso, the Phase III HARMONi-2 trial evaluated monotherapy ivonescimab (AK112) against monotherapy pembrolizumab in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have positive PD-L1 expression. In a primary analysis, ivonescimab monotherapy showed a statistically significant improvement in the trial’s primary endpoint of progression-free survival when compared to monotherapy pembrolizumab, thus becoming the first drug to achieve clinically meaningful benefit over pembrolizumab in a randomized late-stage clinical trial in NSCLC. Median progression-free survival was 11.14 months vs. 5.82 months, respectively, for patients receiving ivonescimab vs. pembrolizumab. Comparable serious treatment-related adverse events and discontinuation rates were observed; serious treatment-related adverse events were 20.8% vs. 16.1%, respectively, in ivonescimab and pembrolizumab arms. Based on the results of HARMONi-2, Summit ( SMMT) announced plans to initiate HARMONi-7 in early 2025. HARMONi-7 is currently planned as a multi-regional Phase III clinical trial that will compare ivonescimab monotherapy to pembrolizumab monotherapy in patients with metastatic NSCLC whose tumors have high PD-L1 expression.

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