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 (NASDAQ: SMMT) reported Q3 2025 operational progress and plans to submit a BLA for ivonescimab in Q4 2025 based on positive HARMONi Phase III results. The multiregional HARMONi trial showed a PFS HR 0.52 (95% CI 0.41–0.66; p<0.00001) with median PFS 6.8 vs 4.4 months. HARMONi longer-term western follow-up showed consistent PFS benefit and OS trends (primary OS HR 0.79; p=0.057). Summit announced initiation of HARMONi-GI3 in first-line metastatic CRC (planned 600-patient enrollment) and will expand further Phase III plans with details in Q1 2026.
Summit Therapeutics (NASDAQ: SMMT) announced on October 19, 2025 Phase III HARMONi-6 results from Akeso showing ivonescimab plus chemotherapy reduced risk of progression or death by 40% versus tislelizumab plus chemotherapy (HR 0.60; 95% CI: 0.46–0.78; p<0.0001).
Key efficacy metrics: median PFS 11.14 months vs 6.90 months; ORR 75.9% vs 66.5%; DoR 11.20 months vs 8.38 months. Safety was described as manageable with similar serious TRAE rates (32.3% vs 30.2%); higher Grade 3+ possibly VEGF-related events with ivonescimab (7.5% vs 2.3%).
The HARMONi-6 manuscript was published in The Lancet. Summit’s HARMONi-3 registrational trial will analyze squamous and non-squamous cohorts separately, with squamous enrollment expected complete in H1 2026 and a PFS readout expected in H2 2026.
Summit Therapeutics (NASDAQ: SMMT) announced the launch of the global Phase III HARMONi-GI3 trial evaluating ivonescimab + chemotherapy versus bevacizumab + chemotherapy as first-line treatment for unresectable metastatic microsatellite-stable colorectal cancer (MSS/pMMR CRC).
The multiregional study intends to enroll ~600 patients, with progression-free survival as the primary endpoint and U.S. site activations planned before year-end; a conference call is scheduled for Oct 20, 2025, 8:00am ET. Earlier Phase II data presented at ESMO 2024 (AK112-206) reported an ORR 81.8% (95% CI 59.7%–94.8%) and DCR 100% in 22 patients; no treatment-emergent adverse events led to permanent discontinuation of ivonescimab as of the data cutoff.
Summit Therapeutics (NASDAQ: SMMT) will host a Third Quarter 2025 earnings call and an ESMO data update on Monday, October 20, 2025, at 8:00am ET before the market opens.
The data update covers planned disclosure of Phase III HARMONi-6 trial results for investigational bispecific antibody ivonescimab, sponsored and fully managed by partner Akeso and presented at the ESMO 2025 Presidential Symposium on October 19, 2025 (4:30pm–6:30pm CEST / 10:30am–12:30pm EDT). HARMONi-6 compares ivonescimab plus platinum chemo versus tislelizumab plus platinum chemo in locally advanced or metastatic squamous NSCLC, irrespective of PD-L1.
The company will provide a live webcast of the October 20 call and an archived edition via its investor website www.smmttx.com.
Summit Therapeutics (NASDAQ: SMMT) has granted inducement stock options to eight new employees totaling 65,750 shares of common stock. The options were awarded on September 18, 2025, with an exercise price of $19.23 per share, matching the closing price on the grant date.
The options have a 10-year term and will vest in equal annual installments over four years. These grants were made as inducement awards under Nasdaq Listing Rule 5635(c)(4) and were approved by Summit's Compensation Committee from an equity incentive pool established on January 22, 2025.
Summit Therapeutics (NASDAQ:SMMT) announced that data from the Phase III HARMONi-6 trial of ivonescimab will be featured at the ESMO 2025 Presidential Symposium on October 19, 2025. The trial, conducted in China by Akeso, demonstrated a statistically significant improvement in progression-free survival (PFS) when combining ivonescimab with chemotherapy versus tislelizumab plus chemotherapy in first-line treatment of squamous non-small cell lung cancer (NSCLC).
This marks the first known Phase III trial showing superiority over a PD-(L)1 inhibitor combined with chemotherapy in NSCLC. The PFS benefit was observed in both PD-L1-positive and negative tumors, with no new safety concerns. Summit is currently conducting the global HARMONi-3 trial with registrational intent for the US and other regions.
Summit Therapeutics (NASDAQ:SMMT) announced updated results from the global Phase III HARMONi trial for ivonescimab, a novel PD-1/VEGF bispecific antibody. The trial demonstrated an improved overall survival (OS) hazard ratio of 0.78 with a nominal p-value of 0.0332. The median OS was 16.8 months for ivonescimab plus chemotherapy versus 14.0 months for placebo plus chemotherapy.
Key findings include statistically significant progression-free survival (PFS) with a hazard ratio of 0.52 (p0.00001), and higher overall response rates in the ivonescimab arm (45%) compared to placebo (34%). North American patients showed particularly strong results with an OS hazard ratio of 0.70. The drug demonstrated consistent benefits across Western and Asian populations, with a favorable safety profile.
Summit Therapeutics (NASDAQ:SMMT) announced updated data from its Phase III HARMONi trial for ivonescimab plus chemotherapy in EGFR-mutated NSCLC patients. In the longer-term follow-up analysis of Western patients, the treatment showed an improved overall survival (OS) trend with a nominal p-value of 0.0332 versus chemotherapy alone.
Key findings include median OS of 16.8 months for ivonescimab plus chemotherapy vs. 14.0 months for placebo plus chemotherapy. North American patients showed particularly promising results with OS hazard ratio of 0.70. The treatment demonstrated statistically significant progression-free survival (PFS) improvement with hazard ratio of 0.52 (p0.00001)45% vs. 34% for placebo.
The safety profile remained manageable with 7.3% discontinuation rate due to treatment-related adverse events.
Summit Therapeutics (NASDAQ: SMMT) has announced a conference call on September 8, 2025, at 8:00 AM ET to discuss data from their Phase III clinical trial, HARMONi. The presentation will be featured in the Presidential Symposium at the 2025 World Conference on Lung Cancer (WCLC) in Barcelona.
The HARMONi trial is evaluating ivonescimab plus platinum-doublet chemotherapy versus placebo in patients with EGFR-mutated non-small cell lung cancer (NSCLC) who have progressed after treatment with 3rd generation EGFR TKI. The presentation will be accessible through Summit's website, with an archived version available afterward.
Summit Therapeutics (NASDAQ: SMMT) announced that data from their Phase III HARMONi trial of ivonescimab will be presented at the WCLC 2025 Presidential Symposium on September 7, 2025. The trial evaluated ivonescimab plus chemotherapy versus placebo in EGFR-mutated non-small cell lung cancer (NSCLC) patients.
The study demonstrated statistically significant improvement in progression-free survival with a hazard ratio of 0.52 (p<0.00001). While overall survival showed a positive trend with a hazard ratio of 0.79, it did not reach statistical significance (p=0.057). The presentation will be delivered by Dr. Jonathan Goldman from UCLA, marking ivonescimab's second consecutive year at the WCLC Presidential Symposium.