---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-24-030249"
form_type: "8-K"
ticker: "IOVA"
cik: "0001425205"
company_name: "IOVANCE BIOTHERAPEUTICS, INC."
filed_at: "2024-03-04T23:59:59+00:00"
generated_at: "2026-06-05T04:39:57.932825+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# FDA lifts clinical hold on Iovance's IOV-LUN-202 NSCLC trial; enrollment to resume

## Summary
- FDA cleared Iovance to resume patient enrollment in registrational IOV-LUN-202 trial for LN-145 TIL therapy in NSCLC.
- Additional safety and monitoring measures developed with FDA and independent data monitoring committee.
- Iovance expects to complete enrollment of ~120 patients in registrational cohorts by 2025.
- Updated Nov 2023 data showed 71% of confirmed responders had duration of response >6 months.
- Initial preliminary data from July 2023 supported durable responses over available second-line chemotherapies.

## SEC filing metadata
- accession: 0001104659-24-030249
- form_type: 8-K
- ticker: IOVA
- cik: 0001425205
- company_name: IOVANCE BIOTHERAPEUTICS, INC.
- filed_at: 2024-03-04T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1425205/000110465924030249/0001104659-24-030249-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1425205/000110465924030249/tm247846d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-24-030249
- JSON: https://secwatch.observer/filing/0001104659-24-030249.json
- Plain text: https://secwatch.observer/filing/0001104659-24-030249.txt

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