Summit Therapeutics (SMMT.US) rose more than 50% before the market opened on progress in cancer drugs
Clinical data showed that Summit Therapeutics' (SMMT.US) bispecific antibody ivonescimab reduced the risk of disease progression or death by 49% compared to Merck's (MRK.US) key cancer drug Keytruda (pembrolizumab) in the first-line treatment of lung cancer patients. The company's stock once soared 50%, and as of writing, it rose 30.64% to $16.03.
The phase III HARMONi-2 trial was conducted in China by partner AKESF to evaluate the efficacy of ivonescimab (AK112) alone versus pembrolizumab alone in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with PD-L1 expression positive.
In the preliminary analysis, ivonescimab monotherapy showed statistically significant improvement in the primary endpoint of progression-free survival compared to pembrolizumab monotherapy, becoming the first drug to demonstrate a clinically meaningful benefit over pembrolizumab in a randomized late-stage clinical trial in NSCLC.
The median progression-free survival was 11.14 months for ivonescimab and 5.82 months for pembrolizumab. The observed rates of serious treatment-related adverse events and discontinuation were comparable, with 20.8% and 16.1% in the ivonescimab and pembrolizumab groups, respectively.
Based on the HARMONi-2 results, Summit announced plans to initiate HARMONi-7 in early 2025. HARMONi-7 is currently planned as a multi-regional phase III clinical trial to compare ivonescimab monotherapy versus pembrolizumab monotherapy in patients with metastatic NSCLC with high PD-L1 expression.