Lifileucel, a Tumor-Infiltrating Lymphocyte Therapy, in Metastatic Melanoma.
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Date
2021-05-12ICR Author
Author
Sarnaik, AA
Hamid, O
Khushalani, NI
Lewis, KD
Medina, T
Kluger, HM
Thomas, SS
Domingo-Musibay, E
Pavlick, AC
Whitman, ED
Martin-Algarra, S
Corrie, P
Curti, BD
Oláh, J
Lutzky, J
Weber, JS
Larkin, JMG
Shi, W
Takamura, T
Jagasia, M
Qin, H
Wu, X
Chartier, C
Graf Finckenstein, F
Fardis, M
Kirkwood, JM
Chesney, JA
Type
Journal Article
Metadata
Show full item recordAbstract
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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Research team
Melanoma and Kidney Cancer
Melanoma and Kidney Cancer
Language
eng
Date accepted
2021-05-12
License start date
2021-05-12
Citation
Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2021, pp. JCO2100612 - ?