{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-24-064825","form_type":"8-K","ticker":"IOVA","cik":"0001425205","company_name":"IOVANCE BIOTHERAPEUTICS, INC.","filed_at":"2024-05-24T23:59:59+00:00","discovered_at":"2026-05-14T18:03:18.360290+00:00","generated_at":"2026-06-01T08:39:28.110928+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Iovance reports 65% ORR, 30% complete response rate for lifileucel + pembro in frontline melanoma","bullets":["Confirmed ORR of 65.2% (30.4% CR, 34.8% PR) in 23 evaluable frontline advanced melanoma patients.","Median follow-up 21.7 months; nearly all responses ongoing; 53.3% of responders had duration ≥12 months.","All evaluable patients showed target lesion regression; safety consistent with known profiles of pembrolizumab, lymphodepletion, IL-2.","Data supports Phase 3 TILVANCE-301 trial with dual-primary endpoints ORR and PFS; interim ORR analysis may support accelerated approval."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-24-064825","json":"https://secwatch.observer/filing/0001104659-24-064825.json","markdown":"https://secwatch.observer/filing/0001104659-24-064825.md","text":"https://secwatch.observer/filing/0001104659-24-064825.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1425205/000110465924064825/0001104659-24-064825-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1425205/000110465924064825/tm2415493d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-01T08:39:28.110928+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"}