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Real-World Outcomes of Belantamab Mafodotin for Relapsed/Refractory Multiple Myeloma (RRMM): Preliminary Results of a Spanish Expanded Access Program (EAP)
INTRODUCTION: Belantamab mafodotin (BM) is a new anti-BCMA antibody–drug conjugate, recently approved for triple-class relapsed and refractory multiple myeloma (RRMM). We assessed real-world outcomes with BM in patients under the Spanish Expanded Access Program (EAP). METHODS: We conducted an observ...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer Healthcare
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9744371/ https://www.ncbi.nlm.nih.gov/pubmed/36509945 http://dx.doi.org/10.1007/s40487-022-00212-5 |
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author | Alegre, Adrián Benzo, Gonzalo Alonso, Rafael Martínez-López, Joaquín Jimenez-Ubieto, Ana Cuéllar, Clara Askari, Elham Prieto, Elena Aláez, Concepción Aguado, Beatriz Velasco, Alberto Krsnik, Isabel Bocanegra, Ana Llorente, Laura Muñoz-Linares, Cristina Morales, Ana Giménez, Eugenio Iglesias, Rebeca Martínez-Chamorro, Carmen Alonso, Aránzazu Jiménez-Montes, Carmen Blanchard, María J. |
author_facet | Alegre, Adrián Benzo, Gonzalo Alonso, Rafael Martínez-López, Joaquín Jimenez-Ubieto, Ana Cuéllar, Clara Askari, Elham Prieto, Elena Aláez, Concepción Aguado, Beatriz Velasco, Alberto Krsnik, Isabel Bocanegra, Ana Llorente, Laura Muñoz-Linares, Cristina Morales, Ana Giménez, Eugenio Iglesias, Rebeca Martínez-Chamorro, Carmen Alonso, Aránzazu Jiménez-Montes, Carmen Blanchard, María J. |
author_sort | Alegre, Adrián |
collection | PubMed |
description | INTRODUCTION: Belantamab mafodotin (BM) is a new anti-BCMA antibody–drug conjugate, recently approved for triple-class relapsed and refractory multiple myeloma (RRMM). We assessed real-world outcomes with BM in patients under the Spanish Expanded Access Program (EAP). METHODS: We conducted an observational, retrospective, multicenter study including RRMM patients who received ≥ 1 dose of BM (Nov 2019 to Jun 2021). The primary endpoint was overall response rate (ORR). Secondary endpoints were progression-free survival (PFS), overall survival (OS), and incidence of treatment-emergent adverse events (TEAEs). RESULTS: Thirty-three patients were included with a median of 70 years of age (range, 46–79 years). Median time from diagnosis was 71 months (range, 10–858 months). Median prior lines was 5 (range, 3–8 lines); 90% of patients were triple-/quad-/penta-refractory; 48% showed high-risk cytogenetics. Median BM doses was 3 (range 1–16 doses), with a median follow-up of 11 months (6–15 months). ORR was 42.2% (≥ VGPR, 18.2%). Median PFS was 3 months (95% CI 0.92–5.08) in the overall population, and 11 months (HR 0.26; 95% CI 0.10–0.68) for patients who achieved ≥ PR. PFS was not significantly different according to age, cytogenetic risk, and prior therapy lines. OS was 424 days (95% CI 107–740). Non-hematological TEAEs (57.6% of patients; 30.3% ≥ G3) included keratopathy (51.5%; 21.2% ≥ G3) and patient-reported vision-related symptoms (45.5%). Keratopathy was resolved in 70.6% of patients. G3 hematological TEAEs was 18.2%, thrombocytopenia (21.2%). Dose reductions due to TEAEs: 30.3%; delays: 36.4%. Treatment discontinuation causes: progression (54.5%), toxicity (non-ocular; 6%/ocular; 6% /ocular + non-ocular toxicity; 3%), death (6%), and patient’s decision (3%). CONCLUSIONS: BM showed relevant anti-myeloma activity in RRMM with a manageable safety profile. These results corroborate those observed in the BM pivotal trial. |
format | Online Article Text |
id | pubmed-9744371 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Springer Healthcare |
record_format | MEDLINE/PubMed |
spelling | pubmed-97443712022-12-13 Real-World Outcomes of Belantamab Mafodotin for Relapsed/Refractory Multiple Myeloma (RRMM): Preliminary Results of a Spanish Expanded Access Program (EAP) Alegre, Adrián Benzo, Gonzalo Alonso, Rafael Martínez-López, Joaquín Jimenez-Ubieto, Ana Cuéllar, Clara Askari, Elham Prieto, Elena Aláez, Concepción Aguado, Beatriz Velasco, Alberto Krsnik, Isabel Bocanegra, Ana Llorente, Laura Muñoz-Linares, Cristina Morales, Ana Giménez, Eugenio Iglesias, Rebeca Martínez-Chamorro, Carmen Alonso, Aránzazu Jiménez-Montes, Carmen Blanchard, María J. Oncol Ther Original Research INTRODUCTION: Belantamab mafodotin (BM) is a new anti-BCMA antibody–drug conjugate, recently approved for triple-class relapsed and refractory multiple myeloma (RRMM). We assessed real-world outcomes with BM in patients under the Spanish Expanded Access Program (EAP). METHODS: We conducted an observational, retrospective, multicenter study including RRMM patients who received ≥ 1 dose of BM (Nov 2019 to Jun 2021). The primary endpoint was overall response rate (ORR). Secondary endpoints were progression-free survival (PFS), overall survival (OS), and incidence of treatment-emergent adverse events (TEAEs). RESULTS: Thirty-three patients were included with a median of 70 years of age (range, 46–79 years). Median time from diagnosis was 71 months (range, 10–858 months). Median prior lines was 5 (range, 3–8 lines); 90% of patients were triple-/quad-/penta-refractory; 48% showed high-risk cytogenetics. Median BM doses was 3 (range 1–16 doses), with a median follow-up of 11 months (6–15 months). ORR was 42.2% (≥ VGPR, 18.2%). Median PFS was 3 months (95% CI 0.92–5.08) in the overall population, and 11 months (HR 0.26; 95% CI 0.10–0.68) for patients who achieved ≥ PR. PFS was not significantly different according to age, cytogenetic risk, and prior therapy lines. OS was 424 days (95% CI 107–740). Non-hematological TEAEs (57.6% of patients; 30.3% ≥ G3) included keratopathy (51.5%; 21.2% ≥ G3) and patient-reported vision-related symptoms (45.5%). Keratopathy was resolved in 70.6% of patients. G3 hematological TEAEs was 18.2%, thrombocytopenia (21.2%). Dose reductions due to TEAEs: 30.3%; delays: 36.4%. Treatment discontinuation causes: progression (54.5%), toxicity (non-ocular; 6%/ocular; 6% /ocular + non-ocular toxicity; 3%), death (6%), and patient’s decision (3%). CONCLUSIONS: BM showed relevant anti-myeloma activity in RRMM with a manageable safety profile. These results corroborate those observed in the BM pivotal trial. Springer Healthcare 2022-12-12 /pmc/articles/PMC9744371/ /pubmed/36509945 http://dx.doi.org/10.1007/s40487-022-00212-5 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by-nc/4.0/Open AccessThis article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) . |
spellingShingle | Original Research Alegre, Adrián Benzo, Gonzalo Alonso, Rafael Martínez-López, Joaquín Jimenez-Ubieto, Ana Cuéllar, Clara Askari, Elham Prieto, Elena Aláez, Concepción Aguado, Beatriz Velasco, Alberto Krsnik, Isabel Bocanegra, Ana Llorente, Laura Muñoz-Linares, Cristina Morales, Ana Giménez, Eugenio Iglesias, Rebeca Martínez-Chamorro, Carmen Alonso, Aránzazu Jiménez-Montes, Carmen Blanchard, María J. Real-World Outcomes of Belantamab Mafodotin for Relapsed/Refractory Multiple Myeloma (RRMM): Preliminary Results of a Spanish Expanded Access Program (EAP) |
title | Real-World Outcomes of Belantamab Mafodotin for Relapsed/Refractory Multiple Myeloma (RRMM): Preliminary Results of a Spanish Expanded Access Program (EAP) |
title_full | Real-World Outcomes of Belantamab Mafodotin for Relapsed/Refractory Multiple Myeloma (RRMM): Preliminary Results of a Spanish Expanded Access Program (EAP) |
title_fullStr | Real-World Outcomes of Belantamab Mafodotin for Relapsed/Refractory Multiple Myeloma (RRMM): Preliminary Results of a Spanish Expanded Access Program (EAP) |
title_full_unstemmed | Real-World Outcomes of Belantamab Mafodotin for Relapsed/Refractory Multiple Myeloma (RRMM): Preliminary Results of a Spanish Expanded Access Program (EAP) |
title_short | Real-World Outcomes of Belantamab Mafodotin for Relapsed/Refractory Multiple Myeloma (RRMM): Preliminary Results of a Spanish Expanded Access Program (EAP) |
title_sort | real-world outcomes of belantamab mafodotin for relapsed/refractory multiple myeloma (rrmm): preliminary results of a spanish expanded access program (eap) |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9744371/ https://www.ncbi.nlm.nih.gov/pubmed/36509945 http://dx.doi.org/10.1007/s40487-022-00212-5 |
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