The DOI matches its Crossref record; 35 of the 35 references it cites were found in a registry or an index.
Lifileucel, a Tumor-Infiltrating Lymphocyte Therapy, in Metastatic Melanoma
Open accessAbstract
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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Metadata
- Authors
- Sarnaik, A. A., Hamid, O., Khushalani, N. I., Lewis, K. D., Medina, T., Kluger, H. M., Thomas, S. S., Domingo-Musibay, E., Pavlick, A. C., Whitman, E. D., Martin-Algarra, S., Corrie, P., Curti, B. D., Oláh, J., Lutzky, J., Weber, J. S., Larkin, J. M. G., Shi, W., Takamura, T., Jagasia, M., Qin, H., Wu, X., Chartier, C., Graf Finckenstein, F., Fardis, M., Kirkwood, J. M., & Chesney, J. A.
- Venue
- Journal of Clinical Oncology
- Published
- 2021-08-20
- Volume
- 39
- Issue
- 24
- Pages
- 2656-2666
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W3162968491
- Cited by
- 451
- References
- 35
- FWCI
- 19.49
- Type
- journal article
- Language
- en
- Open access
- hybrid
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- Sarnaik, A. A., Hamid, O., Khushalani, N. I., Lewis, K. D., Medina, T., Kluger, H. M., Thomas, S. S., Domingo-Musibay, E., Pavlick, A. C., Whitman, E. D., Martin-Algarra, S., Corrie, P., Curti, B. D., Oláh, J., Lutzky, J., Weber, J. S., Larkin, J. M. G., Shi, W., Takamura, T., . . . Chesney, J. A. (2021). Lifileucel, a Tumor-Infiltrating Lymphocyte Therapy, in Metastatic Melanoma. Journal of Clinical Oncology. https://doi.org/10.1200/jco.21.00612
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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
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