Summit Therapeutics shares tumble following interim analysis

  • April 25, 2025

Investing.com -- Summit Therapeutics Inc. (NASDAQ: SMMT ) stock plummeted 37% after the company announced an interim analysis requested by Chinese health authorities showed a positive trend for its drug Ivonescimab compared to Pembrolizumab in PD-L1 positive advanced NSCLC, but failed to reassure investors.

The analysis, part of the HARMONi-2 Phase III trial conducted in China, revealed a hazard ratio of 0.777 at 39% data maturity, suggesting a potential 22% reduction in the risk of death compared to Pembrolizumab. Despite these results, the market responded negatively, reflecting concerns over the preliminary nature of the data and the uncertainty it brings.

Summit’s press release highlighted the approval of Ivonescimab by the NMPA in China for front-line PD-L1 positive advanced NSCLC and the company’s ongoing enrollment in the HARMONi-7 study. The global HARMONi-7 trial is evaluating Ivonescimab monotherapy against Pembrolizumab monotherapy with registration intent for the United States and other regions.

Ivonescimab is a novel bispecific antibody that targets PD-1 and VEGF, potentially offering improved efficacy and safety over existing treatments. It is currently involved in multiple Phase III trials and has been administered to over 2,300 patients worldwide. Summit has initiated clinical development of Ivonescimab in NSCLC, with several trials underway, including HARMONi and HARMONi-3, and is activating sites in the United States for HARMONi-7.

Despite the optimistic view from Summit’s leadership, the stock’s significant drop indicates that investors may be seeking more conclusive evidence of Ivonescimab’s efficacy and market potential. The company expects to announce top-line results from the HARMONi trial in the middle of this year, which may provide further clarity on the drug’s prospects and impact on the company’s financial performance.

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