Lifileucel, a tumor-infiltrating lymphocyte therapy, in metastatic melanoma

Sarnaik, A. (Amod)|||/items/a6b7c8a1-ebe5-4c1a-aec4-d689a3b40d11; Hamid, O. (Omid)|||/items/40b60891-4896-4a3f-9003-9b64c3643552; Khushalani, N. (Nikhil)|||/items/e59fcafa-80e8-459a-9b50-550da0e41271; Lewis, K. (Karl)|||/items/5c86afd4-8c8b-447c-98bc-51a18263c6fb; Medina, T. (Theresa)|||/items/7047082b-6bf2-4ba5-b6a0-5ec4d7701dac; Kluger, H. (Harriet)|||/items/8929cf4a-05b4-4bee-b1dd-84e7de4fa7c7; Thomas, S. (Sajeve)|||/items/73292690-04f6-4eb3-9244-5e4bd35f3493; Domingo-Musibay, E. (Evidio)|||/items/309dc73c-a1c7-4e7d-9313-2ed1d561117b; Pavlick, A. (Anna)|||/items/3ddda5f0-f2f7-4680-8f55-e244f29f1e29; Whitman, E. (Eric)|||/items/ae4d7565-c7af-41f0-99fd-3d84bf848d6a; Martin-Algarra, S. (Salvador)|||/items/2fba8e8b-e087-4ab0-82e3-a4d157f1e0cc; Corrie, P. (Pippa)|||/items/79ad3948-4653-4c1b-9c04-37395756fc83; Curti, B. (Brendan)|||/items/98ab1389-79b1-4929-93df-5d81f96c948e; Olah, J. (Judit)|||/items/df47b993-ac67-442c-b1a7-e2a0a0b2811e; Lutzky, J. (Jose)|||/items/027488e2-7e44-4aa4-ad53-c487601eb4e7; Qin, H. (Harry)|||/items/741bb7c9-5d11-4cd1-ab55-bb7057f40b99; Wu, X. (Xiao)|||/items/e6c903a6-bf51-47a0-b1bb-d949f4d32b83; Chartier, C. (Cecile)|||/items/96b31079-8f89-42f9-a0c5-d3de751f8d13; Graf-Finckenstein, F. (Friedrich)|||/items/c6ac679d-b42e-438a-9fff-1b2042ec7c73; Fardis, M. (Maria)|||/items/6f512a14-22a9-40f7-96a9-d8e2c8011aa0; Kirkwood, J.M. (John M.)|||/items/634ba495-d984-4bb5-944b-ae3c56dec41a; Chesney, J. (Jason)|||/items/bae35291-ab67-4a9e-a77e-e65215a90445

Lifileucel, a tumor-infiltrating lymphocyte therapy, in metastatic melanoma

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. Lifileu...

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Detalhes bibliográficos
Autores:	Sarnaik, A. (Amod)\|\|\|/items/a6b7c8a1-ebe5-4c1a-aec4-d689a3b40d11, Hamid, O. (Omid)\|\|\|/items/40b60891-4896-4a3f-9003-9b64c3643552, Khushalani, N. (Nikhil)\|\|\|/items/e59fcafa-80e8-459a-9b50-550da0e41271, Lewis, K. (Karl)\|\|\|/items/5c86afd4-8c8b-447c-98bc-51a18263c6fb, Medina, T. (Theresa)\|\|\|/items/7047082b-6bf2-4ba5-b6a0-5ec4d7701dac, Kluger, H. (Harriet)\|\|\|/items/8929cf4a-05b4-4bee-b1dd-84e7de4fa7c7, Thomas, S. (Sajeve)\|\|\|/items/73292690-04f6-4eb3-9244-5e4bd35f3493, Domingo-Musibay, E. (Evidio)\|\|\|/items/309dc73c-a1c7-4e7d-9313-2ed1d561117b, Pavlick, A. (Anna)\|\|\|/items/3ddda5f0-f2f7-4680-8f55-e244f29f1e29, Whitman, E. (Eric)\|\|\|/items/ae4d7565-c7af-41f0-99fd-3d84bf848d6a, Martin-Algarra, S. (Salvador)\|\|\|/items/2fba8e8b-e087-4ab0-82e3-a4d157f1e0cc, Corrie, P. (Pippa)\|\|\|/items/79ad3948-4653-4c1b-9c04-37395756fc83, Curti, B. (Brendan)\|\|\|/items/98ab1389-79b1-4929-93df-5d81f96c948e, Olah, J. (Judit)\|\|\|/items/df47b993-ac67-442c-b1a7-e2a0a0b2811e, Lutzky, J. (Jose)\|\|\|/items/027488e2-7e44-4aa4-ad53-c487601eb4e7, Qin, H. (Harry)\|\|\|/items/741bb7c9-5d11-4cd1-ab55-bb7057f40b99, Wu, X. (Xiao)\|\|\|/items/e6c903a6-bf51-47a0-b1bb-d949f4d32b83, Chartier, C. (Cecile)\|\|\|/items/96b31079-8f89-42f9-a0c5-d3de751f8d13, Graf-Finckenstein, F. (Friedrich)\|\|\|/items/c6ac679d-b42e-438a-9fff-1b2042ec7c73, Fardis, M. (Maria)\|\|\|/items/6f512a14-22a9-40f7-96a9-d8e2c8011aa0, Kirkwood, J.M. (John M.)\|\|\|/items/634ba495-d984-4bb5-944b-ae3c56dec41a, Chesney, J. (Jason)\|\|\|/items/bae35291-ab67-4a9e-a77e-e65215a90445
Formato:	artículo
Fecha de publicación:	2021
País:	España
Recursos:	Universidad de Navarra
Repositorio:	Dadun. Depósito Académico Digital de la Universidad de Navarra
Idioma:	inglés
OAI Identifier:	oai:dadun.unav.edu:10171/68514
Acesso em linha:	https://hdl.handle.net/10171/68514
Access Level:	acceso abierto
Palavra-chave:	Metastatic Unresectable Melanoma Immune checkpoint inhibitors

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oai_identifier_str	oai:dadun.unav.edu:10171/68514
network_acronym_str	ES
network_name_str	España
repository_id_str
spelling	Lifileucel, a tumor-infiltrating lymphocyte therapy, in metastatic melanomaSarnaik, A. (Amod)\|\|\|/items/a6b7c8a1-ebe5-4c1a-aec4-d689a3b40d11Hamid, O. (Omid)\|\|\|/items/40b60891-4896-4a3f-9003-9b64c3643552Khushalani, N. (Nikhil)\|\|\|/items/e59fcafa-80e8-459a-9b50-550da0e41271Lewis, K. (Karl)\|\|\|/items/5c86afd4-8c8b-447c-98bc-51a18263c6fbMedina, T. (Theresa)\|\|\|/items/7047082b-6bf2-4ba5-b6a0-5ec4d7701dacKluger, H. (Harriet)\|\|\|/items/8929cf4a-05b4-4bee-b1dd-84e7de4fa7c7Thomas, S. (Sajeve)\|\|\|/items/73292690-04f6-4eb3-9244-5e4bd35f3493Domingo-Musibay, E. (Evidio)\|\|\|/items/309dc73c-a1c7-4e7d-9313-2ed1d561117bPavlick, A. (Anna)\|\|\|/items/3ddda5f0-f2f7-4680-8f55-e244f29f1e29Whitman, E. (Eric)\|\|\|/items/ae4d7565-c7af-41f0-99fd-3d84bf848d6aMartin-Algarra, S. (Salvador)\|\|\|/items/2fba8e8b-e087-4ab0-82e3-a4d157f1e0ccCorrie, P. (Pippa)\|\|\|/items/79ad3948-4653-4c1b-9c04-37395756fc83Curti, B. (Brendan)\|\|\|/items/98ab1389-79b1-4929-93df-5d81f96c948eOlah, J. (Judit)\|\|\|/items/df47b993-ac67-442c-b1a7-e2a0a0b2811eLutzky, J. (Jose)\|\|\|/items/027488e2-7e44-4aa4-ad53-c487601eb4e7Qin, H. (Harry)\|\|\|/items/741bb7c9-5d11-4cd1-ab55-bb7057f40b99Wu, X. (Xiao)\|\|\|/items/e6c903a6-bf51-47a0-b1bb-d949f4d32b83Chartier, C. (Cecile)\|\|\|/items/96b31079-8f89-42f9-a0c5-d3de751f8d13Graf-Finckenstein, F. (Friedrich)\|\|\|/items/c6ac679d-b42e-438a-9fff-1b2042ec7c73Fardis, M. (Maria)\|\|\|/items/6f512a14-22a9-40f7-96a9-d8e2c8011aa0Kirkwood, J.M. (John M.)\|\|\|/items/634ba495-d984-4bb5-944b-ae3c56dec41aChesney, J. (Jason)\|\|\|/items/bae35291-ab67-4a9e-a77e-e65215a90445MetastaticUnresectableMelanomaImmune checkpoint inhibitorsPurpose: 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.AscoDadun. Depósito Académico Digital Universidad de Navarra20242024-01-2420212021-01-0120212021-01-01journal articlehttp://purl.org/coar/resource_type/c_6501info:eu-repo/semantics/articleapplication/pdfhttps://hdl.handle.net/10171/68514reponame:Dadun. Depósito Académico Digital de la Universidad de Navarrainstname:Universidad de NavarraInglésengopen accesshttp://purl.org/coar/access_right/c_abf2info:eu-repo/semantics/openAccessoai:dadun.unav.edu:10171/685142026-06-21T12:47:57Z
dc.title.none.fl_str_mv	Lifileucel, a tumor-infiltrating lymphocyte therapy, in metastatic melanoma
title	Lifileucel, a tumor-infiltrating lymphocyte therapy, in metastatic melanoma
spellingShingle	Lifileucel, a tumor-infiltrating lymphocyte therapy, in metastatic melanoma Sarnaik, A. (Amod)\|\|\|/items/a6b7c8a1-ebe5-4c1a-aec4-d689a3b40d11 Metastatic Unresectable Melanoma Immune checkpoint inhibitors
title_short	Lifileucel, a tumor-infiltrating lymphocyte therapy, in metastatic melanoma
title_full	Lifileucel, a tumor-infiltrating lymphocyte therapy, in metastatic melanoma
title_fullStr	Lifileucel, a tumor-infiltrating lymphocyte therapy, in metastatic melanoma
title_full_unstemmed	Lifileucel, a tumor-infiltrating lymphocyte therapy, in metastatic melanoma
title_sort	Lifileucel, a tumor-infiltrating lymphocyte therapy, in metastatic melanoma
dc.creator.none.fl_str_mv	Sarnaik, A. (Amod)\|\|\|/items/a6b7c8a1-ebe5-4c1a-aec4-d689a3b40d11 Hamid, O. (Omid)\|\|\|/items/40b60891-4896-4a3f-9003-9b64c3643552 Khushalani, N. (Nikhil)\|\|\|/items/e59fcafa-80e8-459a-9b50-550da0e41271 Lewis, K. (Karl)\|\|\|/items/5c86afd4-8c8b-447c-98bc-51a18263c6fb Medina, T. (Theresa)\|\|\|/items/7047082b-6bf2-4ba5-b6a0-5ec4d7701dac Kluger, H. (Harriet)\|\|\|/items/8929cf4a-05b4-4bee-b1dd-84e7de4fa7c7 Thomas, S. (Sajeve)\|\|\|/items/73292690-04f6-4eb3-9244-5e4bd35f3493 Domingo-Musibay, E. (Evidio)\|\|\|/items/309dc73c-a1c7-4e7d-9313-2ed1d561117b Pavlick, A. (Anna)\|\|\|/items/3ddda5f0-f2f7-4680-8f55-e244f29f1e29 Whitman, E. (Eric)\|\|\|/items/ae4d7565-c7af-41f0-99fd-3d84bf848d6a Martin-Algarra, S. (Salvador)\|\|\|/items/2fba8e8b-e087-4ab0-82e3-a4d157f1e0cc Corrie, P. (Pippa)\|\|\|/items/79ad3948-4653-4c1b-9c04-37395756fc83 Curti, B. (Brendan)\|\|\|/items/98ab1389-79b1-4929-93df-5d81f96c948e Olah, J. (Judit)\|\|\|/items/df47b993-ac67-442c-b1a7-e2a0a0b2811e Lutzky, J. (Jose)\|\|\|/items/027488e2-7e44-4aa4-ad53-c487601eb4e7 Qin, H. (Harry)\|\|\|/items/741bb7c9-5d11-4cd1-ab55-bb7057f40b99 Wu, X. (Xiao)\|\|\|/items/e6c903a6-bf51-47a0-b1bb-d949f4d32b83 Chartier, C. (Cecile)\|\|\|/items/96b31079-8f89-42f9-a0c5-d3de751f8d13 Graf-Finckenstein, F. (Friedrich)\|\|\|/items/c6ac679d-b42e-438a-9fff-1b2042ec7c73 Fardis, M. (Maria)\|\|\|/items/6f512a14-22a9-40f7-96a9-d8e2c8011aa0 Kirkwood, J.M. (John M.)\|\|\|/items/634ba495-d984-4bb5-944b-ae3c56dec41a Chesney, J. (Jason)\|\|\|/items/bae35291-ab67-4a9e-a77e-e65215a90445
author	Sarnaik, A. (Amod)\|\|\|/items/a6b7c8a1-ebe5-4c1a-aec4-d689a3b40d11
author_facet	Sarnaik, A. (Amod)\|\|\|/items/a6b7c8a1-ebe5-4c1a-aec4-d689a3b40d11 Hamid, O. (Omid)\|\|\|/items/40b60891-4896-4a3f-9003-9b64c3643552 Khushalani, N. (Nikhil)\|\|\|/items/e59fcafa-80e8-459a-9b50-550da0e41271 Lewis, K. (Karl)\|\|\|/items/5c86afd4-8c8b-447c-98bc-51a18263c6fb Medina, T. (Theresa)\|\|\|/items/7047082b-6bf2-4ba5-b6a0-5ec4d7701dac Kluger, H. (Harriet)\|\|\|/items/8929cf4a-05b4-4bee-b1dd-84e7de4fa7c7 Thomas, S. (Sajeve)\|\|\|/items/73292690-04f6-4eb3-9244-5e4bd35f3493 Domingo-Musibay, E. (Evidio)\|\|\|/items/309dc73c-a1c7-4e7d-9313-2ed1d561117b Pavlick, A. (Anna)\|\|\|/items/3ddda5f0-f2f7-4680-8f55-e244f29f1e29 Whitman, E. (Eric)\|\|\|/items/ae4d7565-c7af-41f0-99fd-3d84bf848d6a Martin-Algarra, S. (Salvador)\|\|\|/items/2fba8e8b-e087-4ab0-82e3-a4d157f1e0cc Corrie, P. (Pippa)\|\|\|/items/79ad3948-4653-4c1b-9c04-37395756fc83 Curti, B. (Brendan)\|\|\|/items/98ab1389-79b1-4929-93df-5d81f96c948e Olah, J. (Judit)\|\|\|/items/df47b993-ac67-442c-b1a7-e2a0a0b2811e Lutzky, J. (Jose)\|\|\|/items/027488e2-7e44-4aa4-ad53-c487601eb4e7 Qin, H. (Harry)\|\|\|/items/741bb7c9-5d11-4cd1-ab55-bb7057f40b99 Wu, X. (Xiao)\|\|\|/items/e6c903a6-bf51-47a0-b1bb-d949f4d32b83 Chartier, C. (Cecile)\|\|\|/items/96b31079-8f89-42f9-a0c5-d3de751f8d13 Graf-Finckenstein, F. (Friedrich)\|\|\|/items/c6ac679d-b42e-438a-9fff-1b2042ec7c73 Fardis, M. (Maria)\|\|\|/items/6f512a14-22a9-40f7-96a9-d8e2c8011aa0 Kirkwood, J.M. (John M.)\|\|\|/items/634ba495-d984-4bb5-944b-ae3c56dec41a Chesney, J. (Jason)\|\|\|/items/bae35291-ab67-4a9e-a77e-e65215a90445
author_role	author
author2	Hamid, O. (Omid)\|\|\|/items/40b60891-4896-4a3f-9003-9b64c3643552 Khushalani, N. (Nikhil)\|\|\|/items/e59fcafa-80e8-459a-9b50-550da0e41271 Lewis, K. (Karl)\|\|\|/items/5c86afd4-8c8b-447c-98bc-51a18263c6fb Medina, T. (Theresa)\|\|\|/items/7047082b-6bf2-4ba5-b6a0-5ec4d7701dac Kluger, H. (Harriet)\|\|\|/items/8929cf4a-05b4-4bee-b1dd-84e7de4fa7c7 Thomas, S. (Sajeve)\|\|\|/items/73292690-04f6-4eb3-9244-5e4bd35f3493 Domingo-Musibay, E. (Evidio)\|\|\|/items/309dc73c-a1c7-4e7d-9313-2ed1d561117b Pavlick, A. (Anna)\|\|\|/items/3ddda5f0-f2f7-4680-8f55-e244f29f1e29 Whitman, E. (Eric)\|\|\|/items/ae4d7565-c7af-41f0-99fd-3d84bf848d6a Martin-Algarra, S. (Salvador)\|\|\|/items/2fba8e8b-e087-4ab0-82e3-a4d157f1e0cc Corrie, P. (Pippa)\|\|\|/items/79ad3948-4653-4c1b-9c04-37395756fc83 Curti, B. (Brendan)\|\|\|/items/98ab1389-79b1-4929-93df-5d81f96c948e Olah, J. (Judit)\|\|\|/items/df47b993-ac67-442c-b1a7-e2a0a0b2811e Lutzky, J. (Jose)\|\|\|/items/027488e2-7e44-4aa4-ad53-c487601eb4e7 Qin, H. (Harry)\|\|\|/items/741bb7c9-5d11-4cd1-ab55-bb7057f40b99 Wu, X. (Xiao)\|\|\|/items/e6c903a6-bf51-47a0-b1bb-d949f4d32b83 Chartier, C. (Cecile)\|\|\|/items/96b31079-8f89-42f9-a0c5-d3de751f8d13 Graf-Finckenstein, F. (Friedrich)\|\|\|/items/c6ac679d-b42e-438a-9fff-1b2042ec7c73 Fardis, M. (Maria)\|\|\|/items/6f512a14-22a9-40f7-96a9-d8e2c8011aa0 Kirkwood, J.M. (John M.)\|\|\|/items/634ba495-d984-4bb5-944b-ae3c56dec41a Chesney, J. (Jason)\|\|\|/items/bae35291-ab67-4a9e-a77e-e65215a90445
author2_role	author author author author author author author author author author author author author author author author author author author author author
dc.contributor.none.fl_str_mv	Dadun. Depósito Académico Digital Universidad de Navarra
dc.subject.none.fl_str_mv	Metastatic Unresectable Melanoma Immune checkpoint inhibitors
topic	Metastatic Unresectable Melanoma Immune checkpoint inhibitors
description	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.
publishDate	2021
dc.date.none.fl_str_mv	2021 2021-01-01 2021 2021-01-01 2024 2024-01-24
dc.type.none.fl_str_mv	journal article http://purl.org/coar/resource_type/c_6501
dc.type.openaire.fl_str_mv	info:eu-repo/semantics/article
format	article
dc.identifier.none.fl_str_mv	https://hdl.handle.net/10171/68514
url	https://hdl.handle.net/10171/68514
dc.language.none.fl_str_mv	Inglés eng
language_invalid_str_mv	Inglés
language	eng
dc.rights.none.fl_str_mv	open access http://purl.org/coar/access_right/c_abf2
dc.rights.openaire.fl_str_mv	info:eu-repo/semantics/openAccess
rights_invalid_str_mv	open access http://purl.org/coar/access_right/c_abf2
eu_rights_str_mv	openAccess
dc.format.none.fl_str_mv	application/pdf
dc.publisher.none.fl_str_mv	Asco
publisher.none.fl_str_mv	Asco
dc.source.none.fl_str_mv	reponame:Dadun. Depósito Académico Digital de la Universidad de Navarra instname:Universidad de Navarra
instname_str	Universidad de Navarra
reponame_str	Dadun. Depósito Académico Digital de la Universidad de Navarra
collection	Dadun. Depósito Académico Digital de la Universidad de Navarra
repository.name.fl_str_mv
repository.mail.fl_str_mv
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Lifileucel, a tumor-infiltrating lymphocyte therapy, in metastatic melanoma

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