Clinical TrialJul 23, 2026, 04:13 PM
Summit Ivonescimab Shows OS Benefit in HARMONi-6, HARMONi
AI Summary
Summit Therapeutics reported Q2 2026 financial results and significant clinical progress for ivonescimab. The HARMONi-6 trial demonstrated a statistically significant overall survival benefit (HR 0.66) in 1L squamous NSCLC, marking the first such achievement over an anti-PD-(L)1 regimen. An updated HARMONi analysis showed consistent overall survival (HR 0.76) across Western and Asian patients in EGFRm NSCLC. The company ended the quarter with $690.7 million in cash and investments, while non-GAAP operating expenses increased to $151.8 million due to expanded clinical studies.
Key Highlights
- Ivonescimab HARMONi-6 trial showed statistically significant OS benefit (HR 0.66) in 1L squamous NSCLC.
- Updated HARMONi OS analysis confirmed consistent OS (HR 0.76) in Western and Asian patients.
- FDA PDUFA goal date for ivonescimab BLA in EGFRm NSCLC is November 14, 2026.
- Cash and short-term investments totaled $690.7 million as of June 30, 2026.
- Non-GAAP operating expenses increased to $151.8 million in Q2 2026 from $89.6 million YoY.
- Non-GAAP net loss was $(147.0) million or $(0.19) per share in Q2 2026.
- Sold ridinilazole asset for $500,000 upfront and up to $104.5 million in milestones.
- Initiated new clinical collaborations with Arcus, Revolution Medicines, GORTEC, and GSK.
Price Impact
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