{"schema_version":"secwatch.filing_event.v1","accession":"0001599298-24-000092","form_type":"8-K","ticker":"SMMT","cik":"0001599298","company_name":"Summit Therapeutics Inc.","filed_at":"2024-05-24T23:59:59+00:00","discovered_at":"2026-05-14T18:03:19.157479+00:00","generated_at":"2026-06-01T08:43:17.609337+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Summit partner Akeso wins China NMPA approval for ivonescimab in EGFR-mutated NSCLC","bullets":["NMPA approved ivonescimab + chemo for EGFR-mutated advanced non-squamous NSCLC after TKI failure.","First regulatory approval for ivonescimab globally; based on HARMONi-A Phase III trial.","Median PFS by IRRC: 7.06 mo (ivonescimab) vs 4.80 mo (chemo alone); HR 0.46 (95% CI 0.34-0.62).","Grade ≥3 TEAEs: 61.5% in ivonescimab arm vs 49.1% in chemo arm; mostly chemo-related.","Approval does not affect Summit's US/global development plan; HARMONi and HARMONi-3 trials continue."],"urls":{"canonical":"https://secwatch.observer/filing/0001599298-24-000092","json":"https://secwatch.observer/filing/0001599298-24-000092.json","markdown":"https://secwatch.observer/filing/0001599298-24-000092.md","text":"https://secwatch.observer/filing/0001599298-24-000092.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1599298/000159929824000092/0001599298-24-000092-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1599298/000159929824000092/smmt-20240524.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-01T08:43:17.609337+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"}