---
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"
generated_at: "2026-06-01T08:39:28.110928+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Iovance reports 65% ORR, 30% complete response rate for lifileucel + pembro in frontline melanoma

## Summary
- 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.

## SEC filing metadata
- 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
- 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/1425205/000110465924064825/0001104659-24-064825-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1425205/000110465924064825/tm2415493d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-24-064825
- JSON: https://secwatch.observer/filing/0001104659-24-064825.json
- Plain text: https://secwatch.observer/filing/0001104659-24-064825.txt

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