---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-23-079364"
form_type: "8-K"
ticker: "IOVA"
cik: "0001425205"
company_name: "IOVANCE BIOTHERAPEUTICS, INC."
filed_at: "2023-07-10T23:59:59+00:00"
generated_at: "2026-06-13T10:31:59.772146+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Iovance gets FDA positive feedback for TIL therapy in NSCLC; 26.1% ORR in 23 patients

## Summary
- FDA Type B meeting supports IOV-LUN-202 trial design for accelerated approval of LN-145 in post-anti-PD-1 advanced NSCLC.
- Preliminary data cut shows 26.1% ORR (6/23 patients) with one complete response and five partial responses; disease control rate 82.6%.
- Plans to enroll ~120 patients in registrational trial; enrollment expected complete H2 2024.
- Lifileucel BLA for advanced melanoma remains on Priority Review; PDUFA date Nov 25, 2023.

## SEC filing metadata
- accession: 0001104659-23-079364
- form_type: 8-K
- ticker: IOVA
- cik: 0001425205
- company_name: IOVANCE BIOTHERAPEUTICS, INC.
- filed_at: 2023-07-10T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- 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/1425205/000110465923079364/0001104659-23-079364-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1425205/000110465923079364/tm2320915d3_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-23-079364
- JSON: https://secwatch.observer/filing/0001104659-23-079364.json
- Plain text: https://secwatch.observer/filing/0001104659-23-079364.txt

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