Welcome to our dedicated page for Summit Therapeutics news (Ticker: SMMT), a resource for investors and traders seeking the latest updates and insights on Summit Therapeutics stock.
Summit Therapeutics Inc. develops oncology medicines led by ivonescimab, an investigational PD-1 / VEGF bispecific antibody in-licensed from Akeso. The company reports clinical and operational updates for ivonescimab programs in non-small cell lung cancer and colorectal cancer, including multiregional Phase III studies and data presentations from HARMONi trials.
Recurring Summit Therapeutics news also covers financial results, regulatory updates tied to the accepted Biologics License Application for ivonescimab in EGFR-mutated non-squamous NSCLC after tyrosine kinase inhibitor therapy, clinical trial collaborations, and equity-compensation actions under Nasdaq rules. Summit holds development and commercialization rights for ivonescimab across North America, South America, Europe, the Middle East, Africa, and Japan.
Summit Therapeutics (SMMT)/b) reported updated overall survival (OS) data from the global Phase III HARMONi trial of ivonescimab plus platinum-doublet chemotherapy in EGFR-mutated NSCLC, presented at WCLC 2026.The June 2026 global intention-to-treat analysis showed an OS hazard ratio of 0.76 (95% CI: 0.61–0.95; nominal p=0.0151) versus placebo plus chemotherapy, with median OS of 16.8 vs 14.0 months, unchanged from earlier cuts. Western patients achieved an OS hazard ratio of 0.76 (95% CI: 0.52–1.10) and median OS of 17.5 vs 14.0 months at 23.2 months’ median follow-up, aligning with Asian results. No new safety signals were seen and the safety profile remained acceptable and manageable.
In Akeso’s China-only Phase III HARMONi-2, ivonescimab monotherapy improved OS versus pembrolizumab with a hazard ratio of 0.73 (95% CI: 0.57–0.95; p=0.009) and median OS of 30.8 vs 22.6 months. Summit’s BLA for ivonescimab in the HARMONi setting has a U.S. FDA PDUFA goal date of November 14, 2026.
Summit Therapeutics (SMMT) highlighted updated Phase III HARMONi-2 results showing ivonescimab reduced death risk by 27% versus pembrolizumab.
The China-based, randomized, double-blind study in PD-L1-positive advanced NSCLC (n=398) reported median overall survival of 30.8 months with ivonescimab versus 22.6 months with pembrolizumab, with a stratified OS hazard ratio of 0.73 (95% CI: 0.57–0.95; p=0.009) after 36 months median follow-up. In the PD-L1 ≥50% subgroup, the hazard ratio was 0.58 (95% CI: 0.38–0.89). Serious treatment-related adverse events occurred in 29.9% of ivonescimab patients versus 21.6% for pembrolizumab, while discontinuations due to treatment-related events were 4.1% and 5.0%, respectively.
Ivonescimab is approved and commercially available in China and remains investigational in Summit’s territories; a separate BLA based on the HARMONi study has been accepted by the FDA with a goal PDUFA date of November 14, 2026. Summit is also running the global Phase III HARMONi-7 trial in PD-L1 high-expressing metastatic NSCLC.
Summit Therapeutics (SMMT)/b) highlighted that partner Akeso’s Phase III HARMONi-2 trial showed ivonescimab monotherapy achieved a statistically significant overall survival benefit versus pembrolizumab monotherapy in PD-L1-positive advanced NSCLC.In this randomized, double-blind study conducted in China, ivonescimab had previously met the primary endpoint of progression-free survival (PFS) by independent radiologic review, with a hazard ratio of 0.51 (95% CI: 0.38–0.69; p<0.0001). Akeso obtained Chinese marketing authorization for ivonescimab in April 2025 based on HARMONi-2, and the drug has been commercially available in China since an initial approval in May 2024.
Ivonescimab (SMT112 in Summit territories) is a tetravalent, bispecific anti-PD-1/anti-VEGF antibody being studied in at least 16 Phase III trials worldwide, including five Summit-sponsored global studies. A separate Summit HARMONi Phase III NSCLC trial supported a BLA that the FDA accepted in January 2026, with a goal PDUFA decision date of November 14, 2026. Ivonescimab remains investigational and unapproved in Summit’s licensed regions, including the United States and Europe.
Summit Therapeutics (NASDAQ: SMMT) reported that partner Akeso announced positive topline results from the randomized Phase III HARMONi-GI1 trial in first-line advanced biliary tract cancer (BTC). In this single-region, multi-center study conducted in China, ivonescimab plus chemotherapy achieved statistically significant and clinically meaningful superiority in the primary endpoint of overall survival versus durvalumab plus chemotherapy, at a prespecified interim analysis.
The trial also met key secondary endpoints of progression-free survival and objective response rate. Detailed safety and efficacy data are expected at a future medical congress and in a peer-reviewed journal. Ivonescimab (SMT112 in Summit territories) is a bispecific PD-1/VEGF antibody engineered by Akeso, with over 4,000 patients treated in clinical studies and more than 70,000 in commercial use in China. Ivonescimab is approved in China for non-small cell lung cancer but remains investigational and unapproved in Summit’s territories, where a separate HARMONi-based BLA for NSCLC is under FDA review with a PDUFA date of November 14, 2026.
Summit Therapeutics (NASDAQ: SMMT) reported that primary analysis results from the global Phase III HARMONi trial of ivonescimab plus platinum-doublet chemotherapy in EGFR-mutated, locally advanced or metastatic non-squamous NSCLC after third-generation EGFR TKI progression were published in The Lancet Oncology.
According to Summit, ivonescimab plus chemotherapy achieved median progression-free survival of 6.8 months versus 4.4 months with placebo plus chemotherapy, with a hazard ratio of 0.52 (95% CI: 0.41–0.66; p<0.0001). Overall survival showed a positive trend but was not statistically significant at primary analysis. Treatment-related grade 3–5 hemorrhage occurred in <1% of ivonescimab-treated patients. An updated analysis showed a continued positive OS trend, including a hazard ratio of 0.76 in western patients. Ivonescimab is under FDA review via a BLA for this indication with a PDUFA target date of November 14, 2026.
Summit Therapeutics (NASDAQ:SMMT) reported that partner Akeso received NMPA marketing authorization in China for ivonescimab plus chemotherapy as first-line treatment for patients with advanced squamous non-small cell lung cancer (NSCLC). This is the third NMPA-approved indication for an ivonescimab-containing regimen in China since its initial approval in May 2024.
The decision is based on the Phase III HARMONi-6 trial, which showed statistically significant and clinically meaningful superiority in both progression-free survival and overall survival versus tislelizumab plus chemotherapy, with an acceptable, manageable safety profile. Ivonescimab remains investigational outside China, including in Summit’s territories, where multiple Phase III trials and a US BLA review (PDUFA date November 14, 2026) are ongoing.
Summit Therapeutics (NASDAQ: SMMT) is expanding its ivonescimab program into urothelial carcinoma with the global, multi‑regional Phase II/III HARMONi‑GU1 trial. The randomized study will test ivonescimab plus enfortumab vedotin (EV) versus pembrolizumab plus EV, a widely used standard of care, as first‑line therapy for previously untreated locally advanced or metastatic urothelial carcinoma.
HARMONi‑GU1 plans to enroll about 800 patients through Phase III. Phase II will select the Phase III dose; Phase III primary endpoints are progression‑free survival and overall survival. According to Summit, global site activations are expected to begin by Q4 2026, bringing ivonescimab’s Phase III program to 16 trials across multiple tumor types, including NSCLC and CRC. Four NSCLC Phase III studies, including Summit’s HARMONi trial and three Akeso studies in China, have reported positive results. Summit’s HARMONi BLA has been accepted by the FDA with a PDUFA goal date of November 14, 2026, while ivonescimab remains investigational in Summit’s territories but was approved in China in May 2024.
Summit Therapeutics (NASDAQ: SMMT) reported second quarter 2026 results and detailed progress for its bispecific PD‑1/VEGF antibody ivonescimab. According to Summit Therapeutics, the FDA accepted its BLA for ivonescimab plus chemotherapy in EGFR‑mutated NSCLC, with a PDUFA date of November 14, 2026. An updated Phase III HARMONi OS analysis showed a hazard ratio of 0.76 for the ITT population, with the same 0.76 HR in both Asian and western subgroups.
In China’s Phase III HARMONi‑6 trial, ivonescimab plus chemotherapy achieved a statistically significant OS benefit versus a tislelizumab regimen, with an OS hazard ratio of 0.66. Enrollment in both cohorts of global Phase III HARMONi‑3 is complete. Summit ended the quarter with $690.7 million in cash and investments; Q2 2026 GAAP net loss was $215.7 million, and non‑GAAP net loss was $147.0 million.
Arcus Biosciences (NYSE: RCUS) and Summit Therapeutics (Nasdaq: SMMT) entered a clinical trial collaboration to evaluate Arcus’s HIF-2α inhibitor casdatifan (AB521) combined with Summit’s PD‑1/VEGF bispecific antibody ivonescimab in clear cell renal cell carcinoma, including first-line metastatic disease.
Arcus will sponsor and conduct a new combination cohort within its ARC‑20 platform study; Summit will supply ivonescimab. Both companies will share study costs and retain development and commercialization rights to their respective molecules. Initial data from this combination are expected by mid‑2027, adding to Arcus’s broader casdatifan program and Summit’s growing ivonescimab franchise.
Summit Therapeutics (Nasdaq: SMMT) reported updated overall survival (OS) results from the global Phase III HARMONi trial of ivonescimab plus platinum-doublet chemotherapy in EGFR‑mutated, locally advanced or metastatic non-squamous NSCLC previously treated with a third‑generation EGFR TKI. The April 2025 primary OS analysis showed a hazard ratio (HR) of 0.79 (95% CI: 0.62–1.01; p=0.057) and median OS of 16.8 vs 14.0 months for ivonescimab versus placebo, respectively. Subsequent analyses with longer follow-up, including a June 2026 data cut, yielded OS HRs of 0.78 and then 0.76 in both the intention‑to‑treat and western subgroups, aligning western outcomes with Asian patients. According to Summit, safety remained acceptable with no new signals. These data support a Biologics License Application for ivonescimab, accepted by the FDA with a PDUFA goal action date of November 14, 2026.