Pembrolizumab as consolidation strategy in patients with multiple myeloma: Results of the GEM-Pembresid clinical trial

PD1 expression in CD4+ and CD8+ T cells is increased after treatment in multiple myeloma patients with persistent disease. The GEM-Pembresid trial analyzed the efficacy and safety of pembrolizumab as consolidation in patients achieving at least very good partial response but with persistent measurab...

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Autores: Puig, N. (Noemí)|||/items/6ff3624a-2657-4823-b2a4-68b3f7b42ba2, Corchete-Sánchez, L.A. (Luis A.)|||/items/f1a8d365-20f0-469d-a620-b55be72eb8f9, Pérez-Morán, J. (José)|||/items/ad7ae590-dfde-44fc-9130-e219b4a96740, Dávila, J. (Julio)|||/items/a98c0b8a-b870-45e9-b3a8-247bc9ec7584, Paino, T. (Teresa)|||/items/6aa89228-ce13-42f3-9876-f78bc55e6f44, Rubia, J. (Javier) de la|||/items/685756d6-8eb3-4223-a37a-845076723414, Oriol, A. (Albert)|||/items/6b2a6860-c90e-4147-86b6-664e85f36400, Martín-Sánchez, J. (Jesús)|||/items/8c12891b-ed9f-4e30-914e-83f542607a03, Arriba, F. (Felipe) de|||/items/47ce8d3a-0cde-4695-9a83-14c297ffba09, Bladé, J. (Joan)|||/items/2e3393a4-11c5-4a58-8b64-52150839a266, Blanchard, M.J. (María Jesús)|||/items/a0c7898b-0d59-4946-9baa-2a53654ea973, Gonzalez-Calle, V. (Veronica)|||/items/a2b3aa81-dedb-4212-a595-89bdc9ad8def, García-Sanz, R. (Ramón)|||/items/a1eb0718-40a6-4c41-a26a-df95ea92f2b5, Paiva, B. (Bruno)|||/items/b2c3efc5-27e1-4425-b452-efba1522c1d5, Lahuerta, J.J. (Juan José)|||/items/fd31a0c2-8942-4d10-a5ef-df2037229340, San-Miguel, J.F. (Jesús F.)|||/items/114f598d-f226-4fa6-aa75-909241328543, Mateos, M.V. (María Victoria)|||/items/13d4d308-51d0-4808-8051-67042c4f3f61, Ocio, E.M. (Enrique M.)|||/items/2e2c579b-5c69-4327-bbef-0107e8ab4f2e
Tipo de recurso: artículo
Fecha de publicación:2020
País:España
Institución:Universidad de Navarra
Repositorio:Dadun. Depósito Académico Digital de la Universidad de Navarra
Idioma:inglés
OAI Identifier:oai:dadun.unav.edu:10171/67664
Acceso en línea:https://hdl.handle.net/10171/67664
Access Level:acceso abierto
Palabra clave:Pembrolizumab
Immunotherapy
Myeloma
Consolidation
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spelling Pembrolizumab as consolidation strategy in patients with multiple myeloma: Results of the GEM-Pembresid clinical trialPuig, N. (Noemí)|||/items/6ff3624a-2657-4823-b2a4-68b3f7b42ba2Corchete-Sánchez, L.A. (Luis A.)|||/items/f1a8d365-20f0-469d-a620-b55be72eb8f9Pérez-Morán, J. (José)|||/items/ad7ae590-dfde-44fc-9130-e219b4a96740Dávila, J. (Julio)|||/items/a98c0b8a-b870-45e9-b3a8-247bc9ec7584Paino, T. (Teresa)|||/items/6aa89228-ce13-42f3-9876-f78bc55e6f44Rubia, J. (Javier) de la|||/items/685756d6-8eb3-4223-a37a-845076723414Oriol, A. (Albert)|||/items/6b2a6860-c90e-4147-86b6-664e85f36400Martín-Sánchez, J. (Jesús)|||/items/8c12891b-ed9f-4e30-914e-83f542607a03Arriba, F. (Felipe) de|||/items/47ce8d3a-0cde-4695-9a83-14c297ffba09Bladé, J. (Joan)|||/items/2e3393a4-11c5-4a58-8b64-52150839a266Blanchard, M.J. (María Jesús)|||/items/a0c7898b-0d59-4946-9baa-2a53654ea973Gonzalez-Calle, V. (Veronica)|||/items/a2b3aa81-dedb-4212-a595-89bdc9ad8defGarcía-Sanz, R. (Ramón)|||/items/a1eb0718-40a6-4c41-a26a-df95ea92f2b5Paiva, B. (Bruno)|||/items/b2c3efc5-27e1-4425-b452-efba1522c1d5Lahuerta, J.J. (Juan José)|||/items/fd31a0c2-8942-4d10-a5ef-df2037229340San-Miguel, J.F. (Jesús F.)|||/items/114f598d-f226-4fa6-aa75-909241328543Mateos, M.V. (María Victoria)|||/items/13d4d308-51d0-4808-8051-67042c4f3f61Ocio, E.M. (Enrique M.)|||/items/2e2c579b-5c69-4327-bbef-0107e8ab4f2ePembrolizumabImmunotherapyMyelomaConsolidationPD1 expression in CD4+ and CD8+ T cells is increased after treatment in multiple myeloma patients with persistent disease. The GEM-Pembresid trial analyzed the efficacy and safety of pembrolizumab as consolidation in patients achieving at least very good partial response but with persistent measurable disease after first- or second-line treatment. Moreover, the characteristics of the immune system were investigated to identify potential biomarkers of response to pembrolizumab. One out of the 17 evaluable patients showed a decrease in the amount of M-protein, although a potential late effect of high-dose melphalan could not be ruled out. Fourteen adverse events were considered related to pembrolizumab, two of which (G3 diarrhea and G2 pneumonitis) prompted treatment discontinuation and all resolving without sequelae. Interestingly, pembrolizumab induced a decrease in the percentage of NK cells at cycle 3, due to the reduction of the circulating and adaptive subsets (0.615 vs. 0.43, p = 0.007; 1.12 vs. 0.86, p = 0.02). In the early progressors, a significantly lower expression of PD1 in CD8+ effector memory T cells (MFI 1327 vs. 926, p = 0.03) was observed. In conclusion, pembrolizumab used as consolidation monotherapy shows an acceptable toxicity profile but did not improve responses in this MM patient population. The trial was registered at clinicaltrials.gov with identifier NCT02636010 and with EUDRACT number 2015-003359-23.MDPI AGDadun. Depósito Académico Digital Universidad de Navarra20232023-10-1820202020-01-0120202020-01-01journal articlehttp://purl.org/coar/resource_type/c_6501info:eu-repo/semantics/articleapplication/pdfhttps://hdl.handle.net/10171/67664reponame: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:10171/676642026-06-21T12:47:57Z
dc.title.none.fl_str_mv Pembrolizumab as consolidation strategy in patients with multiple myeloma: Results of the GEM-Pembresid clinical trial
title Pembrolizumab as consolidation strategy in patients with multiple myeloma: Results of the GEM-Pembresid clinical trial
spellingShingle Pembrolizumab as consolidation strategy in patients with multiple myeloma: Results of the GEM-Pembresid clinical trial
Puig, N. (Noemí)|||/items/6ff3624a-2657-4823-b2a4-68b3f7b42ba2
Pembrolizumab
Immunotherapy
Myeloma
Consolidation
title_short Pembrolizumab as consolidation strategy in patients with multiple myeloma: Results of the GEM-Pembresid clinical trial
title_full Pembrolizumab as consolidation strategy in patients with multiple myeloma: Results of the GEM-Pembresid clinical trial
title_fullStr Pembrolizumab as consolidation strategy in patients with multiple myeloma: Results of the GEM-Pembresid clinical trial
title_full_unstemmed Pembrolizumab as consolidation strategy in patients with multiple myeloma: Results of the GEM-Pembresid clinical trial
title_sort Pembrolizumab as consolidation strategy in patients with multiple myeloma: Results of the GEM-Pembresid clinical trial
dc.creator.none.fl_str_mv Puig, N. (Noemí)|||/items/6ff3624a-2657-4823-b2a4-68b3f7b42ba2
Corchete-Sánchez, L.A. (Luis A.)|||/items/f1a8d365-20f0-469d-a620-b55be72eb8f9
Pérez-Morán, J. (José)|||/items/ad7ae590-dfde-44fc-9130-e219b4a96740
Dávila, J. (Julio)|||/items/a98c0b8a-b870-45e9-b3a8-247bc9ec7584
Paino, T. (Teresa)|||/items/6aa89228-ce13-42f3-9876-f78bc55e6f44
Rubia, J. (Javier) de la|||/items/685756d6-8eb3-4223-a37a-845076723414
Oriol, A. (Albert)|||/items/6b2a6860-c90e-4147-86b6-664e85f36400
Martín-Sánchez, J. (Jesús)|||/items/8c12891b-ed9f-4e30-914e-83f542607a03
Arriba, F. (Felipe) de|||/items/47ce8d3a-0cde-4695-9a83-14c297ffba09
Bladé, J. (Joan)|||/items/2e3393a4-11c5-4a58-8b64-52150839a266
Blanchard, M.J. (María Jesús)|||/items/a0c7898b-0d59-4946-9baa-2a53654ea973
Gonzalez-Calle, V. (Veronica)|||/items/a2b3aa81-dedb-4212-a595-89bdc9ad8def
García-Sanz, R. (Ramón)|||/items/a1eb0718-40a6-4c41-a26a-df95ea92f2b5
Paiva, B. (Bruno)|||/items/b2c3efc5-27e1-4425-b452-efba1522c1d5
Lahuerta, J.J. (Juan José)|||/items/fd31a0c2-8942-4d10-a5ef-df2037229340
San-Miguel, J.F. (Jesús F.)|||/items/114f598d-f226-4fa6-aa75-909241328543
Mateos, M.V. (María Victoria)|||/items/13d4d308-51d0-4808-8051-67042c4f3f61
Ocio, E.M. (Enrique M.)|||/items/2e2c579b-5c69-4327-bbef-0107e8ab4f2e
author Puig, N. (Noemí)|||/items/6ff3624a-2657-4823-b2a4-68b3f7b42ba2
author_facet Puig, N. (Noemí)|||/items/6ff3624a-2657-4823-b2a4-68b3f7b42ba2
Corchete-Sánchez, L.A. (Luis A.)|||/items/f1a8d365-20f0-469d-a620-b55be72eb8f9
Pérez-Morán, J. (José)|||/items/ad7ae590-dfde-44fc-9130-e219b4a96740
Dávila, J. (Julio)|||/items/a98c0b8a-b870-45e9-b3a8-247bc9ec7584
Paino, T. (Teresa)|||/items/6aa89228-ce13-42f3-9876-f78bc55e6f44
Rubia, J. (Javier) de la|||/items/685756d6-8eb3-4223-a37a-845076723414
Oriol, A. (Albert)|||/items/6b2a6860-c90e-4147-86b6-664e85f36400
Martín-Sánchez, J. (Jesús)|||/items/8c12891b-ed9f-4e30-914e-83f542607a03
Arriba, F. (Felipe) de|||/items/47ce8d3a-0cde-4695-9a83-14c297ffba09
Bladé, J. (Joan)|||/items/2e3393a4-11c5-4a58-8b64-52150839a266
Blanchard, M.J. (María Jesús)|||/items/a0c7898b-0d59-4946-9baa-2a53654ea973
Gonzalez-Calle, V. (Veronica)|||/items/a2b3aa81-dedb-4212-a595-89bdc9ad8def
García-Sanz, R. (Ramón)|||/items/a1eb0718-40a6-4c41-a26a-df95ea92f2b5
Paiva, B. (Bruno)|||/items/b2c3efc5-27e1-4425-b452-efba1522c1d5
Lahuerta, J.J. (Juan José)|||/items/fd31a0c2-8942-4d10-a5ef-df2037229340
San-Miguel, J.F. (Jesús F.)|||/items/114f598d-f226-4fa6-aa75-909241328543
Mateos, M.V. (María Victoria)|||/items/13d4d308-51d0-4808-8051-67042c4f3f61
Ocio, E.M. (Enrique M.)|||/items/2e2c579b-5c69-4327-bbef-0107e8ab4f2e
author_role author
author2 Corchete-Sánchez, L.A. (Luis A.)|||/items/f1a8d365-20f0-469d-a620-b55be72eb8f9
Pérez-Morán, J. (José)|||/items/ad7ae590-dfde-44fc-9130-e219b4a96740
Dávila, J. (Julio)|||/items/a98c0b8a-b870-45e9-b3a8-247bc9ec7584
Paino, T. (Teresa)|||/items/6aa89228-ce13-42f3-9876-f78bc55e6f44
Rubia, J. (Javier) de la|||/items/685756d6-8eb3-4223-a37a-845076723414
Oriol, A. (Albert)|||/items/6b2a6860-c90e-4147-86b6-664e85f36400
Martín-Sánchez, J. (Jesús)|||/items/8c12891b-ed9f-4e30-914e-83f542607a03
Arriba, F. (Felipe) de|||/items/47ce8d3a-0cde-4695-9a83-14c297ffba09
Bladé, J. (Joan)|||/items/2e3393a4-11c5-4a58-8b64-52150839a266
Blanchard, M.J. (María Jesús)|||/items/a0c7898b-0d59-4946-9baa-2a53654ea973
Gonzalez-Calle, V. (Veronica)|||/items/a2b3aa81-dedb-4212-a595-89bdc9ad8def
García-Sanz, R. (Ramón)|||/items/a1eb0718-40a6-4c41-a26a-df95ea92f2b5
Paiva, B. (Bruno)|||/items/b2c3efc5-27e1-4425-b452-efba1522c1d5
Lahuerta, J.J. (Juan José)|||/items/fd31a0c2-8942-4d10-a5ef-df2037229340
San-Miguel, J.F. (Jesús F.)|||/items/114f598d-f226-4fa6-aa75-909241328543
Mateos, M.V. (María Victoria)|||/items/13d4d308-51d0-4808-8051-67042c4f3f61
Ocio, E.M. (Enrique M.)|||/items/2e2c579b-5c69-4327-bbef-0107e8ab4f2e
author2_role author
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author
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author
author
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dc.contributor.none.fl_str_mv Dadun. Depósito Académico Digital Universidad de Navarra
dc.subject.none.fl_str_mv Pembrolizumab
Immunotherapy
Myeloma
Consolidation
topic Pembrolizumab
Immunotherapy
Myeloma
Consolidation
description PD1 expression in CD4+ and CD8+ T cells is increased after treatment in multiple myeloma patients with persistent disease. The GEM-Pembresid trial analyzed the efficacy and safety of pembrolizumab as consolidation in patients achieving at least very good partial response but with persistent measurable disease after first- or second-line treatment. Moreover, the characteristics of the immune system were investigated to identify potential biomarkers of response to pembrolizumab. One out of the 17 evaluable patients showed a decrease in the amount of M-protein, although a potential late effect of high-dose melphalan could not be ruled out. Fourteen adverse events were considered related to pembrolizumab, two of which (G3 diarrhea and G2 pneumonitis) prompted treatment discontinuation and all resolving without sequelae. Interestingly, pembrolizumab induced a decrease in the percentage of NK cells at cycle 3, due to the reduction of the circulating and adaptive subsets (0.615 vs. 0.43, p = 0.007; 1.12 vs. 0.86, p = 0.02). In the early progressors, a significantly lower expression of PD1 in CD8+ effector memory T cells (MFI 1327 vs. 926, p = 0.03) was observed. In conclusion, pembrolizumab used as consolidation monotherapy shows an acceptable toxicity profile but did not improve responses in this MM patient population. The trial was registered at clinicaltrials.gov with identifier NCT02636010 and with EUDRACT number 2015-003359-23.
publishDate 2020
dc.date.none.fl_str_mv 2020
2020-01-01
2020
2020-01-01
2023
2023-10-18
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/10171/67664
url https://hdl.handle.net/10171/67664
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 MDPI AG
publisher.none.fl_str_mv MDPI AG
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
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