Full metadata record
DC Field | Value | Language |
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dc.creator | Sarnaik, A. (Amod) | - |
dc.creator | Hamid, O. (Omid) | - |
dc.creator | Khushalani, N. (Nikhil) | - |
dc.creator | Lewis, K. (Karl) | - |
dc.creator | Medina, T. (Theresa) | - |
dc.creator | Kluger, H. (Harriet) | - |
dc.creator | Thomas, S. (Sajeve) | - |
dc.creator | Domingo-Musibay, E. (Evidio) | - |
dc.creator | Pavlick, A. (Anna) | - |
dc.creator | Whitman, E. (Eric) | - |
dc.creator | Martin-Algarra, S. (Salvador) | - |
dc.creator | Corrie, P. (Pippa) | - |
dc.creator | Curti, B. (Brendan) | - |
dc.creator | Olah, J. (Judit) | - |
dc.creator | Lutzky, J. (Jose) | - |
dc.creator | Qin, H. (Harry) | - |
dc.creator | Wu, X. (Xiao) | - |
dc.creator | Chartier, C. (Cecile) | - |
dc.creator | Graf-Finckenstein, F. (Friedrich) | - |
dc.creator | Fardis, M. (Maria) | - |
dc.creator | Kirkwood, J.M. (John M.) | - |
dc.creator | Chesney, J. (Jason) | - |
dc.date.accessioned | 2024-01-24T13:57:44Z | - |
dc.date.available | 2024-01-24T13:57:44Z | - |
dc.date.issued | 2021 | - |
dc.identifier.citation | Sarnaik, A. (Amod); Hamid, O. (Omid); Khushalani, N. (Nikhil); et al. "Lifileucel, a tumor-infiltrating lymphocyte therapy, in metastatic melanoma". Journal of clinical oncology. 39 (24), 2021, 2656 - 2666 | es |
dc.identifier.issn | 2692-563X | - |
dc.identifier.uri | https://hdl.handle.net/10171/68514 | - |
dc.description.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. | es_ES |
dc.language.iso | eng | es_ES |
dc.publisher | Asco | es_ES |
dc.rights | info:eu-repo/semantics/openAccess | es_ES |
dc.subject | Metastatic | es_ES |
dc.subject | Unresectable | es_ES |
dc.subject | Melanoma | es_ES |
dc.subject | Immune checkpoint inhibitors | es_ES |
dc.title | Lifileucel, a tumor-infiltrating lymphocyte therapy, in metastatic melanoma | es_ES |
dc.type | info:eu-repo/semantics/article | es_ES |
dc.description.note | Creative Commons Attribution Non-Commercial No Derivatives 4.0 License | es_ES |
dc.identifier.doi | 10.1200/JCO.21.00612 | - |
dadun.citation.endingPage | 2666 | es_ES |
dadun.citation.number | 24 | es_ES |
dadun.citation.publicationName | Journal of clinical oncology | es_ES |
dadun.citation.startingPage | 2656 | es_ES |
dadun.citation.volume | 39 | es_ES |
dc.identifier.pmid | 33979178 | - |
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