Summit Therapeutics Inc. (NASDAQ:SMMT) stock is trading lower on Monday. The company shared progress on its lead drug candidate and third-quarter financial results.
On Sunday, Summit Therapeutics shared results from the Phase 3 HARMONi-6 trial, conducted in China by its partner, Akeso Inc.
The data were presented at the European Society for Medical Oncology 2025 Congress.
The trial showed that Ivonescimab and chemo reduced the risk of progression or death by 40% compared with BeOne Medicines Inc.’s (NASDAQ:ONC) Tevimbra (tislelizumab) and chemo for locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) irrespective of PD-L1 expression.
The ivonescimab combo regimen extended the time patients lived without tumor progression by a median of 4.2 months versus the Tevimbra-based therapy, reaching 11.1 months.
The overall response rate (ORR) and duration of response (DoR) were higher in patients treated with ivonescimab plus chemotherapy than in those treated with tislelizumab plus chemotherapy (75.9% vs. 66.5% and 11.20 months vs. 8.38 months, respectively).
The median follow-up was 10.28 months, and the overall survival endpoint remained immature at the data cutoff.
Summit announces that, based on the results of the HARMONi clinical trial, it plans to submit a Biologics License Application (BLA) to seek approval for ivonescimab plus chemotherapy in the fourth quarter of 2025.
Summit is currently enrolling patients in the HARMONi-3 Phase 3 study to evaluate ivonescimab combined with chemotherapy compared to Merck & Co. Inc.’s (NYSE:MRK) Keytruda (pembrolizumab) combined with chemotherapy for first-line metastatic, squamous and non-squamous NSCLC.
Summit expects to complete enrollment in the squamous cohort of HARMONi-3 in the first half of 2026 and to reach the prespecified number of events for the PFS primary endpoint analysis for this cohort in the second half of 2026. It also expects to complete enrollment in the non-squamous cohort of HARMONi-3 in the second half of 2026 and to reach the prespecified number of events for the PFS primary endpoint analysis for this cohort in the first half of 2027.
Additionally, Summit initiated a new Phase 3 HARMONi-GI3 study in first-line unresectable metastatic colorectal cancer (CRC). The company intends to expand its ivonescimab clinical development program with additional Phase 3 clinical studies. The company will provide additional color with respect to these Phase 3 studies in the first quarter of 2026.
Cash and cash equivalents and short-term investments were $238.6 million at September 30, 2025.
Price Action: SMMT stock is down 8.96% at $19.11 during the premarket session at the last check on Monday.
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