{"schema_version":"secwatch.filing_event.v1","accession":"0001599298-25-000166","form_type":"8-K","ticker":"SMMT","cik":"0001599298","company_name":"Summit Therapeutics Inc.","filed_at":"2025-11-07T23:59:59+00:00","discovered_at":"2026-05-14T18:02:39.877693+00:00","generated_at":"2026-05-16T23:04:43.869042+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Ivonescimab + chemo shows OS benefit in EGFRm NSCLC; HR 0.74 in HARMONi-A final analysis","bullets":["Final OS analysis: ivonescimab+chemo vs chemo achieved HR 0.74 (95% CI: 0.58-0.95, p=0.019); median OS 16.8 vs 14.1 months.","First Phase III study of ivonescimab to show statistically significant OS benefit; prior HARMONi showed PFS benefit.","Over 40,000 patients treated with ivonescimab in China in clinical/commercial settings.","Safety manageable: TRAE discontinuation 11.2% vs 6.2%; no additional TRAE deaths vs chemo alone.","Global HARMONi study subsequent OS analysis: HR 0.78 (nominal p=0.0332) consistent with primary HR 0.79."],"urls":{"canonical":"https://secwatch.observer/filing/0001599298-25-000166","json":"https://secwatch.observer/filing/0001599298-25-000166.json","markdown":"https://secwatch.observer/filing/0001599298-25-000166.md","text":"https://secwatch.observer/filing/0001599298-25-000166.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1599298/000159929825000166/0001599298-25-000166-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1599298/000159929825000166/smmt-20251107.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T23:04:43.869042+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}