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Summit Therapeutics Inc (NASDAQ: SMMT) delivers innovative therapies for high-need medical conditions through focused research in genetic disorders and infectious diseases. This dedicated news hub provides investors and industry observers with essential updates on clinical progress, regulatory milestones, and strategic collaborations.
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Summit (NASDAQ: SMMT) highlighted Phase III HARMONi-A results for partner Akeso showing ivonescimab plus chemotherapy improved overall survival vs chemotherapy alone in EGFR‑mutated NSCLC after EGFR‑TKI.
Key metrics: OS HR 0.74 (95% CI 0.58–0.95, p=0.019); median OS 16.8 months vs 14.1 months. Data cut-off April 2025; median follow‑up 32.5 months. Safety: treatment‑related discontinuations 11.2% vs 6.2%; TRAE deaths 0.6% in each arm. HARMONi global readouts previously showed PFS HR 0.52 and earlier OS analyses with HRs ~0.78–0.79.
Summit Therapeutics (NASDAQ: SMMT) will present at four investor conferences in November–December 2025. Summit leadership will host fireside chats and meet investors at: UBS Global Healthcare Conference in Palm Beach on Nov 10, 2025 at 3:30pm ET; Jefferies Global Healthcare Conference in London on Nov 18, 2025 at 3:30pm GMT (10:30am ET); Citi 2025 Global Healthcare Conference in Miami on Dec 2, 2025 at 10:30am ET; and Evercore Healthcare Conference in Miami on Dec 3, 2025 at 2:10pm ET. The fireside chats will be streamed live and archived on the company website www.smmttx.com.
Summit Therapeutics (NASDAQ: SMMT) said results from the Phase III HARMONi-A trial (sponsored by partner Akeso) will be presented at SITC 2025 on Nov 7, 2025 at 11:30am ET. HARMONi-A evaluated ivonescimab plus platinum-doublet chemotherapy versus placebo plus chemotherapy in EGFR‑mutated, locally advanced or metastatic non-squamous NSCLC after EGFR TKI failure.
The company reported HARMONi-A produced the first statistically significant overall survival (OS) benefit for an ivonescimab-containing regimen versus standard of care in a Phase III study. The single-region study was conducted in China, where >40,000 patients have received ivonescimab in clinical or commercial settings. Summit is sponsoring the multiregional HARMONi Phase III trial and plans a BLA submission based on the multiregional study; ivonescimab is not approved in Summit territories including the US and Europe.
Summit Therapeutics (NASDAQ: SMMT) completed a private placement raising approximately $500 million by selling about 26.68 million common shares at $18.74 per share on October 21, 2025.
Insiders and related parties invested $282 million (including $272 million from named executives and employees and $10 million from Akeso). Summit said it intends to use net proceeds to advance clinical development of ivonescimab and for working capital and general corporate purposes.
The shares were sold in an unregistered transaction and Summit agreed to file an SEC registration statement to register resale of the shares.
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.
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