Iovance's Phase 2 Lifileucel Plus Pembrolizumab Delivers 62.5% ORR And 29.2% Complete Response Rate In Frontline Advanced Melanoma, With Median OS Not Yet Reached At 50.9 Months

62.5% Confirmed Objective Response Rate (ORR) and 29.2% Complete Response (CR) Rate in Final Phase 2 Analysis

Median Overall Survival (OS) Not Reached at More than 4 Years of Median Follow-up

Oral Presentation at the European Society for Medical Oncology (ESMO) Congress 2026 Reinforces Ongoing TILVANCE-301 Phase 3 Trial

PHILADELPHIA and MADRID, Oct. 23, 2026 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ:IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, today announced that one-time lifileucel combined with pembrolizumab demonstrated a 62.5% ORR and a 29.2% CR rate, with median OS not reached at 50.9 months of median study follow-up in the final Phase 2 analysis in frontline advanced melanoma. The Phase 2 results were presented on October 23, 2026 in a Proffered Paper oral session at the ESMO Congress 2026 in Madrid, Spain.

In frontline advanced melanoma, approximately half of patients treated with combination immune checkpoint inhibitor (ICI) therapy do not achieve long-term benefit, a widely recognized unmet need.1 Following successful adoption of lifileucel in the post-anti-PD-1 therapy setting, this Phase 2 data supports the earlier use and potential approval of lifileucel plus pembrolizumab in frontline advanced melanoma. Iovance estimates that 70,000 patients with frontline advanced melanoma are addressable each year in global markets with high prevalence.