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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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