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Iovance Presents New Data at ESMO 2026 Demonstrating Deep, Durable Responses with Lifileucel TIL Cell Therapy Plus Pembrolizumab in Frontline Advanced Melanoma

Globe Newswire•23/10/2026•10:15 ET
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Key Highlights

  • ➤Lifileucel plus pembrolizumab delivered 62.5% confirmed ORR in frontline advanced melanoma
  • ➤Complete response rate reached 29.2% in final Phase 2 analysis
  • ➤Median overall survival was not reached after 50.9 months’ median follow-up
  • ➤TILVANCE-301 Phase 3 trial is enrolling at more than 80 global sites
  • ➤Iovance estimates 70,000 frontline advanced melanoma patients are addressable annually globally

Expert Statements

Andrew J.S. Furness, Consultant Medical Oncologist and Solid Tumour Cellular Therapy Lead at The Royal Marsden National Health Service Foundation Trust; Leader of the Cellular Therapy and Translational Immunology Group at The Institute of Cancer Research, London; Principal Investigator in IOV-COM-202 and TILVANCE-301 trials

“About half of patients do not experience lasting benefit with frontline combination immunotherapy for advanced melanoma”

Andrew J.S. Furness, Consultant Medical Oncologist and Solid Tumour Cellular Therapy Lead at The Royal Marsden National Health Service Foundation Trust; Leader of the Cellular Therapy and Translational Immunology Group at The Institute of Cancer Research, London; Principal Investigator in IOV-COM-202 and TILVANCE-301 trials

“A single administration of lifileucel plus pembrolizumab demonstrated compelling response rates and durability that compare favorably to other ICI combination approaches in frontline advanced melanoma, with median overall survival not reached at more than four years of follow-up. These remarkable Phase 2 results provide a strong scientific rationale to investigate earlier treatment with lifileucel in the TILVANCE-301 trial.”

Noah Berkowitz, Chief Medical Officer of Iovance

“The final Cohort 1A results demonstrate unprecedented efficacy and a potentially best-in-class clinical profile for lifileucel combined with pembrolizumab in frontline advanced melanoma. These data, together with supportive translational findings, reinforce the importance of our ongoing TILVANCE-301 Phase 3 randomized trial to support a new approval for lifileucel in frontline advanced melanoma.”

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

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