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SMR 2019: Tumor-Infiltrating Lymphocyte Therapy for Refractory Metastatic Melanoma

By: Sarah Campen, PharmD
Posted: Monday, December 23, 2019

Treatment with lifileucel appears to produce durable responses in patients with advanced metastatic melanoma who have previously experienced disease progression on multiple prior therapies, according to the 1-year results of a phase II study presented at the 2019 International Congress of The Society for Melanoma Research (SMR) in Salt Lake City. John M. Kirkwood, MD, of the University of Pittsburgh Medical Center Hillman Cancer Center, and colleagues reported that this cryopreserved autologous tumor-infiltrating lymphocyte therapy resulted in a 36.4% overall rate of response in patients with heavily pretreated disease and a high baseline disease burden.

A total of 66 patients with stage IIIC/IV unresectable melanoma were enrolled in the open-label trial. Participants had received a mean of 3.3 prior therapies, including PD-1 checkpoint inhibitors (100%), anti–CTLA-4 therapy (80%), and BRAF/MEK therapy (23%), if clinically indicated. Liver or brain lesions were present in 44% of patients. Therapy consisted of 1 week of lymphodepletion, a single lifileucel infusion, and at least six doses of interleukin-2.

After 12 months of follow-up, the disease control rate was 80.3%, and the overall rate of response was 36.4%, including 2 complete and 22 partial responses. The highest overall rate of response (40.5%) was observed in a subset of patients who were primarily refractory to checkpoint inhibitors. The adverse-event profile was consistent with previous studies.

Disclosure: For full disclosures of the study authors, visit

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