Mitchell Kapoor

Yigal Nochomovitz

Kelly Shi

Mohit Bansal

Reni Benjamin

Bradley Canino

Cory Kasimov

Eric Schmidt

Karina Rabayeva

Asthika Goonewardene

Dara Azar

- Summit Therapeutics announced positive results from the HARMONY six Phase III study for ivenesumab in advanced squamous non-small cell lung cancer, demonstrating a **median progression-free survival of 11.14 months** for the ivenesumab arm compared to **6.90 months** for the control arm, with a **hazard ratio of 0.6**.  **[0001599298_2191449_1]** 
- The company intends to submit a **Biologics License Application (BLA)** to the FDA for ivenesumab plus chemotherapy for EGFR mutant non-small cell lung cancer in **Q4 2025**.  **[0001599298_2191449_0]** **[0001599298_2191449_6]** 
- Summit is expanding its Phase III clinical development program with the addition of the **HARMONY GI III trial**, a global Phase III study evaluating ivenesumab as first-line therapy in unresectable colorectal cancer, bringing the total number of planned or ongoing Phase III trials to **14**.  **[0001599298_2191449_5]** 
- Updates to the HARMONY three study include separate statistical analyses by histology, with enrollment for the squamous cohort expected to complete in **H1 2026** and progression-free survival analysis in **H2 2026**.  **[0001599298_2191449_6]** **[0001599298_2191449_7]** 
- Summit Therapeutics reported a cash position of approximately **$238.66 million** at the end of **Q3 2025**, with non-GAAP operating expenses for the quarter at **$103.4 million**.  **[0001599298_2191449_9]**

Summit Therapeutics Announces Positive HARMONY Six Phase III Results, BLA Submission Plans, and Expanded Clinical Program

- Summit Therapeutics announced positive results from the **Harmony Six** phase three study for ivonescimab in advanced squamous non-small cell lung cancer, demonstrating a statistically significant progression-free survival benefit with a **hazard ratio of 0.60** and a **p-value of less than 0.0001**.  **[0001599298_2191435_1]** **[0001599298_2191435_3]** 
- The company intends to submit a Biologics License Application (BLA) for ivonescimab to the FDA in **Q4 2025** based on the Harmony study results, acknowledging the FDA's expectation for an overall survival benefit for marketing authorization.  **[0001599298_2191435_1]** **[0001599298_2191435_5]** 
- Summit expanded its clinical development program by adding the global phase three **Harmony GI3** trial for first-line colorectal cancer, increasing the total planned or ongoing phase three trials to **14**.  **[0001599298_2191435_4]** **[0001599298_2191435_7]** 
- The protocol for the global phase three **Harmony Three** study was amended to separate statistical analysis by histology, with enrollment for the squamous cohort now expected to complete in **Q1 2026** and progression-free survival data read-out anticipated in **H2 2026**.  **[0001599298_2191435_5]** **[0001599298_2191435_8]** 
- As of the end of **Q3 2025**, Summit Therapeutics held approximately **$238.56 million** in cash, with non-GAAP operating expenses for the quarter totaling **$103.4 million**.  **[0001599298_2191435_8]**

Summit Therapeutics Reports Q3 2025 Results, Positive Harmony Six Data, and BLA Submission Plans

- Summit Therapeutics announced positive **Phase III HARMONi-6 study results** for ivonescimab plus chemotherapy as a first-line treatment for advanced squamous non-small cell lung cancer (NSCLC) in China.  **[0001599298_2191427:4]** **[0001599298_2191427:8]** 
- The study demonstrated a statistically significant improvement in progression-free survival (PFS), with a median PFS of **11.14 months** for ivonescimab plus chemotherapy compared to **6.90 months** for tislelizumab plus chemotherapy, resulting in a Hazard Ratio of **0.60** (95% CI: 0.46, 0.78) and a p-value of **<0.0001**.  **[0001599298_2191427:5]** **[0001599298_2191427:8]** 
- Ivonescimab plus chemotherapy exhibited a **manageable safety profile** consistent with previous experience, and the PFS benefit was observed across all key subgroups and regardless of PD-L1 expression.  **[0001599298_2191427:7]** **[0001599298_2191427:8]** 
- The HARMONi-3 global study for first-line NSCLC is ongoing, with the squamous cohort expected to complete enrollment in **H1 2026** and reach the prespecified number of events for PFS analysis in **H2 2026**.  **[0001599298_2191427:10]**

Summit Therapeutics Announces Positive Phase III HARMONi-6 Study Results for Ivonescimab

- Summit Therapeutics plans to submit a Biologics License Application (BLA) in **Q4 2025** for ivonescimab plus chemotherapy, based on positive HARMONi clinical trial results for EGFR-mutant NSCLC.  **[1599298_0001599298-25-000156_a2025_prx1020xq32025earn.htm:0]** 
- The company reported a **GAAP net loss of $231.8 million** and a **Non-GAAP net loss of $101.0 million** for the third quarter ended September 30, 2025.  **[1599298_0001599298-25-000156_a2025_prx1020xq32025earn.htm:5]** 
- **Cash and cash equivalents and short-term investments** were **$238.6 million** as of September 30, 2025.  **[1599298_0001599298-25-000156_a2025_prx1020xq32025earn.htm:5]** 
- In the HARMONi-6 study, ivonescimab with chemotherapy reduced the risk of disease progression or death by **40%** compared to tislelizumab plus chemotherapy in 1L squamous NSCLC, with a median PFS of **11.14 months** versus **6.90 months** respectively.  **[1599298_0001599298-25-000156_a2025_prx1019xesmoharmon.htm:0]** **[1599298_0001599298-25-000156_a2025_prx1019xesmoharmon.htm:1]** 
- Summit is expanding its ivonescimab global Phase III development program with the initiation of the **HARMONi-GI3 study** in first-line unresectable metastatic colorectal cancer.  **[1599298_0001599298-25-000156_a2025_prx1017xannounceme.htm:0]**

Summit Therapeutics (SMMT)