Summit Therapeutics (SMMT) Company Report

Summit Therapeutics highlighted significant accomplishments in 2025 for ivonescimab, including 14 Phase 3 clinical trials launched globally (4 global, 10 in China) with over 3,000 patients administered ivonescimab in a clinical setting.
Key readouts in 2025 demonstrated ivonescimab's efficacy, with Harmony 6 showing a strong PFS signal in combination with chemotherapy, and Harmony A achieving statistically significant overall survival.
The company emphasized the remarkable consistency of data from East to West and across different treatment settings (PFS to OS, monotherapy to chemo combination), reinforcing ivonescimab's broad applicability.
Summit is expanding ivonescimab's reach beyond non-small cell lung cancer, having opened enrollment in a frontline colorectal cancer study and planning a clinical trial collaboration with Revolution Medicines in early 2026 for RAS inhibitors.
Management believes ivonescimab holds a first-in-class and best-in-class advantage, with four successful Phase 3 readouts, setting a high bar for competitors.

1 day ago

Transcript

Summit Therapeutics Discusses Ivonescimab Clinical Development and Future Strategy

SMMT

New Projects/Investments

Product Launch

Summit Therapeutics' ivonescimab has been administered to over 3,000 patients in clinical settings and over 40,000 patients in the commercial market in China. The company and its partner Akeso have launched 14 Phase 3 clinical trials for ivonescimab, including four global Phase 3s and 10 in China.
In 2025, ivonescimab demonstrated a strong PFS signal in the Harmony 6 study and a statistically significant overall survival benefit in the Harmony A study. The Harmony 2 study also showed a clinically meaningful early ad hoc look with a hazard ratio of 0.777 for overall survival.
The company believes ivonescimab is both first-in-class and best-in-class, supported by four successful Phase 3 studies.
Summit plans to initiate a clinical trial collaboration with Revolution Medicines in early 2026 to explore ivonescimab with multiple RAS inhibitors across various tumor settings.
The Harmony 3 study is expected to complete enrollment shortly, with readouts anticipated in 2026, including an interim overall survival look in the second half of 2026.

1 day ago

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Summit Therapeutics Discusses Ivanesimab Clinical Progress and Future Strategy

SMMT

New Projects/Investments

Revenue Acceleration/Inflection

Product Launch

Summit Therapeutics highlighted the significant progress of ivonescimab in 2025, including 14 Phase 3 clinical trials (4 global, 10 in China) with over 3,000 patients in clinical settings and over 40,000 patients in the commercial market in China.
Key clinical trial readouts in 2025 demonstrated strong results, such as a strong PFS signal in the Harmony 6 study and a clinically meaningful overall survival (OS) hazard ratio of 0.777 in an ad hoc look from Harmony 2. The Harmony A study also achieved a statistically significant OS benefit.
The company is expanding ivonescimab's application beyond lung cancer, with a frontline colorectal cancer study now enrolling patients, and plans for a clinical trial collaboration with Revolution Medicines in early 2026 to explore RAS inhibitors in multiple tumor settings.
Executive Chairman Robert Duggan stated that the company expects sufficient written data within the next 12 months to demonstrate ivonescimab's value, which could lead to a strategic partnership focused on maintaining control and maximizing wealth.

1 day ago

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Summit Therapeutics Provides Update on Ivonescimab Development and Financial Position

SMMT

Product Launch

New Projects/Investments

Guidance Update

Summit Therapeutics anticipates ending FY 2025 with nearly $700 million in cash and has a proven ability to raise significant capital rapidly, having raised $500 million in 48 hours on two separate occasions.
By 2025, ivonescimab (Ivo) has achieved four positive Phase 3 clinical trial readouts (HARMONY-A, HARMONY-2, HARMONY-6) in non-small cell lung cancer (NSCLC), demonstrating strong efficacy and a pristine safety profile.
The company intends to submit its application for ivonescimab in EGFR mutant NSCLC in Q4 2025 and projects potential market entry for frontline squamous NSCLC in 2027.
Summit is strategically expanding its Phase 3 development program beyond NSCLC, with a frontline colorectal cancer trial currently enrolling and further solid tumor indications planned.

2 days ago

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Summit Therapeutics Highlights Strong Clinical Data and Financial Position for Ivonescimab

SMMT

Product Launch

New Projects/Investments

Guidance Update

Summit Therapeutics has achieved four positive Phase III clinical trial readouts for its oncology drug, ivonescimab (Ivo), demonstrating strong efficacy and a "pristine safety profile" against competitors, with 50,000 patients dosed by Akeso by June.
The company anticipates ending FY 2025 with nearly $700 million in the bank and has a track record of rapidly securing capital, including two instances of raising $500 million within 48 hours.
Key upcoming milestones include the planned submission of an application for EGFR in Q4 2025 and the expected completion of enrollment for the HARMONi-3 squamous cohort in H1 2026, with data readout in H2 2026 and potential market entry for frontline squamous lung cancer by 2027.
Summit is expanding its Phase III program beyond lung cancer, with a frontline colorectal trial underway, and is prioritizing independent development over immediate large pharma partnerships to maintain strategic control and accelerate progress.

2 days ago

Transcript

Summit Therapeutics Provides Update on Ivonescimab Development and Financial Position

SMMT

New Projects/Investments

Guidance Update

Product Launch

Summit Therapeutics has reported four positive Phase 3 trials for ivonescimab (Ivo), demonstrating strong efficacy with progression-free survival (PFS) and overall survival (OS) benefits, including wins against Keytruda (Pembro), and a pristine safety profile.
The company intends to submit an application for ivonescimab in EGFR in the fourth quarter of 2025.
Enrollment for the squamous cohort of the HARMONY-3 trial is expected to complete in H1 2026, with results anticipated in H2 2026, potentially accelerating market access for frontline non-small cell lung cancer.
Summit expects to conclude the year with nearly $700 million in cash and has demonstrated the ability to raise significant capital rapidly, such as $500 million in 48 hours.
The company is actively expanding its Phase 3 program beyond non-small cell lung cancer, with a colorectal cancer trial already enrolling patients and plans for additional Phase 3 programs.

2 days ago

Transcript

Summit Therapeutics Provides Update on Ivonescimab Development and Future Milestones

SMMT

Guidance Update

New Projects/Investments

Summit Therapeutics' ivonescimab has been administered to over 40,000 patients (clinical and commercial in China) and is currently in 14 Phase III clinical trials, demonstrating a tolerable safety profile.
Recent data from the HARMONi-6 study showed a 0.60 hazard ratio for progression-free survival (PFS) in squamous non-small cell lung cancer, representing a 40% improvement over standard of care, with a median PFS difference of 11.1 vs 6.8 months.
The HARMONY-A study, the first Phase III study with ivonescimab, demonstrated a statistically significant overall survival (OS) benefit with an updated hazard ratio of 0.74.
Summit plans to file its Biologics License Application (BLA) for ivonescimab in Q4 2025 for the HARMONY trial (second-line EGFR mutant non-small cell lung cancer).
Key upcoming milestones include completing enrollment for the HARMONY-3 squamous arm in H1 2026 with pivotal data expected in H2 2026, and the company has a strong financial position with $750 million in the bank following a $500 million financing.

Nov 18, 2025, 3:30 PM

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Summit Therapeutics Provides Update on Ivonescimab Development and Upcoming Milestones

SMMT

Product Launch

New Projects/Investments

Guidance Update

Summit Therapeutics is focused on developing ivonescimab, a PD-1 VEGF bispecific antibody, for cancer treatment, with over 40,000 patients having received it in clinical and commercial settings.
Recent data from the HARMONi-6 study in frontline squamous non-small cell lung cancer (NSCLC) showed a 0.60 hazard ratio for progression-free survival (PFS), representing a 40% improvement over standard of care, with a median PFS difference of 11.1 versus 6.8 months.
The HARMONi-A study in second-line EGFR mutant NSCLC demonstrated a sustained overall survival (OS) benefit with an updated hazard ratio of 0.74, marking the first randomized Phase 3 study to show an OS benefit over standard of care in this setting.
Summit plans to submit a Biologics License Application (BLA) in Q4 2025 for ivonescimab in second-line EGFR mutant NSCLC.
Key upcoming milestones include completing enrollment for the HARMONi-3 squamous arm in H1 2026 with pivotal data expected in H2 2026, and initiating patient dosing in a collaboration with Revolution Medicine for RAS on inhibitors in early 2026.

Nov 18, 2025, 3:30 PM

Transcript

Summit Therapeutics Discusses Ivonescimab Clinical Progress and BLA Filing Plans

SMMT

Product Launch

New Projects/Investments

Guidance Update

Summit Therapeutics is advancing ivonescimab, a PD-1 VEGF bispecific antibody, with 14 Phase 3 clinical trials globally and in China, having treated over 40,000 patients commercially. Recent data from the HARMONi-6 study showed a 0.60 hazard ratio for progression-free survival (PFS) in squamous non-small cell lung cancer, and HARMONi-A demonstrated a statistically significant overall survival (OS) benefit with a 0.74 hazard ratio.
The company plans to submit a Biologics License Application (BLA) for ivonescimab in the current quarter (Q4 2025) for second-line EGFR mutant non-small cell lung cancer.
Key upcoming clinical milestones include completing enrollment for the squamous arm of HARMONY 3 in the first half of 2026 and the non-squamous arm in the second half of 2026, with pivotal data for the squamous arm expected in the second half of 2026.
Summit maintains a strong financial position with $750 million in the bank after a recent $500 million financing.

Nov 18, 2025, 3:30 PM

Transcript

Summit Therapeutics Provides Updates on Ivonesimab Clinical Trials and Regulatory Strategy

SMMT

New Projects/Investments

Product Launch

Guidance Update

Summit Therapeutics' lead molecule, ivonesimab, a PD-1, VEGF bispecific antibody, demonstrated a statistically significant Overall Survival (OS) benefit in the Harmony A Phase 3 trial with a hazard ratio of 0.74 (p-value 0.019).
The company plans to submit a Biologics License Application (BLA) for ivonesimab in Q4 based on its benefit-risk profile, noting no currently approved regimens in the US for this setting have shown a statistically significant OS benefit.
The Harmony 3 global trial protocol was amended to increase sample size and separately power squamous and non-squamous non-small cell lung cancer cohorts, with squamous enrollment completion expected in H1 2026 and readout in H2 2026.
Summit Therapeutics is expanding ivonesimab's application to other solid tumors, including colorectal cancer, and is collaborating with RevMedica to combine ivonesimab with RAS inhibitors, with patient treatment starting in early 2026.

Nov 10, 2025, 8:30 PM

Transcript

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