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

IOVANCE BIOTHERAPEUTICS, INC.

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.

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