Lifileucel, a Tumor-Infiltrating Lymphocyte Therapy, in Metastatic Melanoma.
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ICR Authors
Authors
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
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
Document Type
Journal Article
Date
2021-05-12
Date Accepted
2021-05-12
Date Available
2021-05-20T13:05:39Z
Abstract
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.
Citation
Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2021, pp. JCO2100612 - ?
Source Title
Publisher
ISSN
0732-183X
eISSN
1527-7755
Collections
Research Team
Melanoma and Kidney Cancer
Melanoma and Kidney Cancer
Melanoma and Kidney Cancer