---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-24-006804"
form_type: "8-K"
ticker: "IOVA"
cik: "0001425205"
company_name: "IOVANCE BIOTHERAPEUTICS, INC."
filed_at: "2024-01-26T23:59:59+00:00"
generated_at: "2026-06-06T16:29:07.851543+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Iovance discloses FDA clinical hold on NSCLC TIL trial; BLA for lifileucel in melanoma under review

## Summary
- FDA placed clinical hold on IOV-LUN-202 trial (NSCLC) on Dec 22, 2023; new enrollment paused.
- BLA for lifileucel in advanced melanoma under FDA review with final label discussions ongoing.
- Presentation reports $428M cash as of 9/30/23 and 90%+ manufacturing success rate.
- Proleukin acquisition closed May 18, 2023 for £167.7M upfront; completed.
- Melanoma data: ORR 31.4% (pooled cohorts 2&4) with median DOR not reached at 36.5 months.

## SEC filing metadata
- accession: 0001104659-24-006804
- form_type: 8-K
- ticker: IOVA
- cik: 0001425205
- company_name: IOVANCE BIOTHERAPEUTICS, INC.
- filed_at: 2024-01-26T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1425205/000110465924006804/0001104659-24-006804-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1425205/000110465924006804/tm244175d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-24-006804
- JSON: https://secwatch.observer/filing/0001104659-24-006804.json
- Plain text: https://secwatch.observer/filing/0001104659-24-006804.txt

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