Sarnaik AA, Hamid O, Khushalani NI, et al. - This phase II open-label, single-arm, multicenter study was conducted to test lifileucel, a one-time, autologous tumor-infiltrating lymphocyte product, for its efficacy and safety in patients suffering from metastatic melanoma who had progressed on standard immune checkpoint inhibitors and targeted therapies (if applicable), who otherwise have limited therapeutic choices. Patients were treated with a nonmyeloablative lymphodepletion regimen, a single infusion of lifileucel, and up to six doses of high-dose interleukin-2. Investigator-assessed objective response rate (ORR) per RECIST, version 1.1, was the primary endpoint. An ORR of 36% was estimated, with two complete responses and 22 partial responses. A disease control rate of 80% was achieved. The estimated ORR and disease control rate were 41% and 81%, respectively, in the primary refractory to anti–programmed death 1 [PD-1] or programmed death ligand 1 [PD-L1] therapy subset. A safety profile consistent with recognized adverse events linked with nonmyeloablative lymphodepletion and interleukin-2, was shown. Overall, durable responses were conferred by lifileucel as well as a major unmet need was also addressed, through lifileucel use, in patients suffering from metastatic melanoma with limited treatment choices after approved therapy, including the primary refractory to anti–PD-1 or PD-L1 therapy subset.