Corrie, P. (Pippa)

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    Lifileucel, a tumor-infiltrating lymphocyte therapy, in metastatic melanoma
    (Asco, 2021) Sarnaik, A. (Amod); Fardis, M. (Maria); Kirkwood, J.M. (John M.); Whitman, E. (Eric); Pavlick, A. (Anna); Medina, T. (Theresa); Martin-Algarra, S. (Salvador); Graf-Finckenstein, F. (Friedrich); Wu, X. (Xiao); Corrie, P. (Pippa); Thomas, S. (Sajeve); Lewis, K. (Karl); Lutzky, J. (Jose); Kluger, H. (Harriet); Khushalani, N. (Nikhil); Hamid, O. (Omid); Curti, B. (Brendan); Olah, J. (Judit); Qin, H. (Harry); Chesney, J. (Jason); Domingo-Musibay, E. (Evidio); Chartier, C. (Cecile)
    Purpose: Effective treatment options are limited for patients with advanced (metastatic or unresectable) melanoma who progress after immune checkpoint inhibitors and targeted therapies. Adoptive cell therapy using tumor-infiltrating lymphocytes has demonstrated efficacy in advanced melanoma. Lifileucel is an autologous, centrally manufactured tumor-infiltrating lymphocyte product. Methods: We conducted a phase II open-label, single-arm, multicenter study in patients with advanced melanoma who had been previously treated with checkpoint inhibitor(s) and BRAF ± MEK targeted agents. Lifileucel was produced from harvested tumor specimens in central Good Manufacturing Practice facilities using a streamlined 22-day process. Patients received a nonmyeloablative lymphodepletion regimen, a single infusion of lifileucel, and up to six doses of high-dose interleukin-2. The primary end point was investigator-assessed objective response rate (ORR) per RECIST, version 1.1. Results: Sixty-six patients received a mean of 3.3 prior therapies (anti-programmed death 1 [PD-1] or programmed death ligand 1 [PD-L1]: 100%; anticytotoxic T-lymphocyte-associated protein-4: 80%; BRAF ± MEK inhibitor: 23%). The ORR was 36% (95% CI, 25 to 49), with two complete responses and 22 partial responses. Disease control rate was 80% (95% CI, 69 to 89). Median duration of response was not reached after 18.7-month median study follow-up (range, 0.2-34.1 months). In the primary refractory to anti-PD-1 or PD-L1 therapy subset, the ORR and disease control rate were 41% (95% CI, 26 to 57) and 81% (95% CI, 66 to 91), respectively. Safety profile was consistent with known adverse events associated with nonmyeloablative lymphodepletion and interleukin-2. Conclusion: Lifileucel demonstrated durable responses and addresses a major unmet need in patients with metastatic melanoma with limited treatment options after approved therapy, including the primary refractory to anti-PD-1 or PD-L1 therapy subset.
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    Safety & efficacy of lifileucel (LN-144) tumor infiltrating lymphocyte therapy in metastatic melanoma patients after progression on multiple therapies – independent review committee data update
    (BMJ, 2020) Sarnaik, A. (Amod); Fardis, M. (Maria); Kirkwood, J.M. (John M.); Whitman, E. (Eric); Pavlick, A. (Anna); Medina, T. (Theresa); Martin-Algarra, S. (Salvador); Mirgoli, M. (Mariam); Corrie, P. (Pippa); Thomas, S. (Sajeve); Lewis, K. (Karl); Wu, R. (Renee); Lutzky, J. (Jose); Kluger, H. (Harriet); Khushalani, N. (Nikhil); Hamid, O. (Omid); Curti, B. (Brendan); Olah, J. (Judit); Shi, W. (Wen); Qin, H. (Harry); Larkin, J. (James); Weber, J.S. (Jeffrey S.); DiTrapani, K. (Kelly); Chesney, J. (Jason); Takamura, T. (Toshimi)
    Treatment options are limited for patients with advanced melanoma who have progressed on checkpoint inhibitors and targeted therapies such as BRAF/MEK inhibitors (if BRAF-V600E mutated). Adoptive cell therapy utilizing tumor-infiltrating lymphocytes (TIL) has shown antitumor efficacy with durable responses in heavily pretreated melanoma patients. Safety and efficacy of lifileucel, a centrally manufactured cryopreserved autologous TIL therapy assessed by both investigator and an independent review committee (IRC), are presented.