---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-24-002290"
form_type: "8-K"
ticker: "IOVA"
cik: "0001425205"
company_name: "IOVANCE BIOTHERAPEUTICS, INC."
filed_at: "2024-01-08T23:59:59+00:00"
generated_at: "2026-06-07T02:09:11.964349+00:00"
event_type: "other_material"
sentiment: "negative"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Iovance updates pipeline: BLA under review, NSCLC trial on hold

## Summary
- BLA for lifileucel in advanced melanoma under FDA review; pre-license inspection of iCTC facility completed in 2023.
- Clinical hold placed on IOV-LUN-202 NSCLC trial on Dec 22, 2023; enrollment paused, prior patients continue monitoring.
- Phase 2 C-144-01 pooled melanoma data: ORR 31.4%, median DOR not reached, 41.7% of responses lasting ≥24 months.
- Phase 3 TILVANCE-301 frontline melanoma trial first patient randomized in 2Q23; dual primary endpoints ORR and PFS.
- Cash $428M as of Sep 30, 2023; Proleukin acquisition for £167.7M upfront closed May 2023.

## SEC filing metadata
- accession: 0001104659-24-002290
- form_type: 8-K
- ticker: IOVA
- cik: 0001425205
- company_name: IOVANCE BIOTHERAPEUTICS, INC.
- filed_at: 2024-01-08T23:59:59+00:00
- event_type: other_material
- sentiment: negative
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1425205/000110465924002290/0001104659-24-002290-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1425205/000110465924002290/tm242451d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-24-002290
- JSON: https://secwatch.observer/filing/0001104659-24-002290.json
- Plain text: https://secwatch.observer/filing/0001104659-24-002290.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.