Summit Therapeutics (US:SMMT) Benzinga·2025-10-20 14:05Core Insights - Summit Therapeutics Inc. reported progress on its lead drug candidate, ivonescimab, and its third-quarter financial results, with stock trading lower [1][7] Clinical Trial Results - The Phase 3 HARMONi-6 trial demonstrated that ivonescimab combined with chemotherapy reduced the risk of progression or death by 40% compared to BeOne Medicines' Tevimbra and chemotherapy for advanced squamous non-small cell lung cancer (NSCLC) [2] - The ivonescimab regimen extended the median time without tumor progression to 11.1 months, an increase of 4.2 months over the Tevimbra-based therapy [2] - The overall response rate (ORR) for ivonescimab plus chemotherapy was 75.9%, compared to 66.5% for tislelizumab plus chemotherapy, with a duration of response (DoR) of 11.20 months versus 8.38 months [3] Future Plans - Based on the HARMONi-6 results, the company plans to submit a Biologics License Application (BLA) for ivonescimab plus chemotherapy in Q4 2025 [4] - Summit is currently enrolling patients in the HARMONi-3 Phase 3 study to compare ivonescimab with Merck's Keytruda for first-line metastatic NSCLC, with expected completion of enrollment in the squamous cohort by H1 2026 [5] - A new Phase 3 HARMONi-GI3 study has been initiated for first-line unresectable metastatic colorectal cancer (CRC), with plans for further expansion of the ivonescimab clinical development program [6] Financial Position - As of September 30, 2025, the company reported cash and cash equivalents of $238.6 million [6]