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Real‐world experience with belantamab mafodotin therapy for relapsed/refractory multiple myeloma: A multicentre retrospective study

Belantamab mafodotin, an immuno‐conjugate targeting B‐cell maturation antigen, showed single‐agent activity in phase 1 and 2 studies, and was recently approved for heavily pretreated relapsed/refractory multiple myeloma (RRMM) patients. Real‐world data and long‐term follow‐up are scarce. We conducte...

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Autores principales: Shragai, Tamir, Magen, Hila, Lavi, Noa, Gatt, Moshe, Trestman, Svetlana, Zektser, Miri, Ganzel, Chezi, Jarchowsky, Osnat, Berger, Tamar, Tadmor, Tamar, Leiba, Merav, Hertzog‐Tzarfaty, Katrin, Horowitz, Netanel, Shapira, Michael, Varssano, David, Berger, Yoav, Frenkel, Shahar, Krauthammer, Mark, Avivi, Irit, Luttwak, Efrat, Cohen, Yael C.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10091809/
https://www.ncbi.nlm.nih.gov/pubmed/36205375
http://dx.doi.org/10.1111/bjh.18479
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author Shragai, Tamir
Magen, Hila
Lavi, Noa
Gatt, Moshe
Trestman, Svetlana
Zektser, Miri
Ganzel, Chezi
Jarchowsky, Osnat
Berger, Tamar
Tadmor, Tamar
Leiba, Merav
Hertzog‐Tzarfaty, Katrin
Horowitz, Netanel
Shapira, Michael
Varssano, David
Berger, Yoav
Frenkel, Shahar
Krauthammer, Mark
Avivi, Irit
Luttwak, Efrat
Cohen, Yael C.
author_facet Shragai, Tamir
Magen, Hila
Lavi, Noa
Gatt, Moshe
Trestman, Svetlana
Zektser, Miri
Ganzel, Chezi
Jarchowsky, Osnat
Berger, Tamar
Tadmor, Tamar
Leiba, Merav
Hertzog‐Tzarfaty, Katrin
Horowitz, Netanel
Shapira, Michael
Varssano, David
Berger, Yoav
Frenkel, Shahar
Krauthammer, Mark
Avivi, Irit
Luttwak, Efrat
Cohen, Yael C.
author_sort Shragai, Tamir
collection PubMed
description Belantamab mafodotin, an immuno‐conjugate targeting B‐cell maturation antigen, showed single‐agent activity in phase 1 and 2 studies, and was recently approved for heavily pretreated relapsed/refractory multiple myeloma (RRMM) patients. Real‐world data and long‐term follow‐up are scarce. We conducted a multisite retrospective study aimed to assess safety and efficacy of belantamab mafodotin monotherapy administered via the GSK expanded access compassionate care programme. One‐hundred and six RRMM patients were treated with belantamab mafodotin between July 2019 and March 2021. The median age was 69.4 years. Patients were heavily pretreated with a median of six (range 2–11) prior therapy lines. Major adverse effects included ocular toxicity (keratopathy 68.4%, grade ≥3: 40.5%; blurred vision 36.8%, grade ≥3: 6.3%), thrombocytopenia (27.4%, grade ≥3: 17.9%) and infections (11.3%, grade ≥3: 7.5%). Median follow‐up time was 11.9 [95% confidence interval (CI) 10.0–13.8] months. Overall response rate was 45.5%. Median progression‐free survival was 4.7 (95% CI 3.5–5.9) months in the entire cohort and 8.8 (95% CI 6.6–10.9) months among responders. Median overall survival was 14.5 (95% CI 9.5–19.6) months, and not reached for responders. To conclude, in a real‐world setting, belantamab mafodotin monotherapy showed efficacy comparable with the prospective clinical trials, with a tolerable toxicity profile.
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spelling pubmed-100918092023-04-13 Real‐world experience with belantamab mafodotin therapy for relapsed/refractory multiple myeloma: A multicentre retrospective study Shragai, Tamir Magen, Hila Lavi, Noa Gatt, Moshe Trestman, Svetlana Zektser, Miri Ganzel, Chezi Jarchowsky, Osnat Berger, Tamar Tadmor, Tamar Leiba, Merav Hertzog‐Tzarfaty, Katrin Horowitz, Netanel Shapira, Michael Varssano, David Berger, Yoav Frenkel, Shahar Krauthammer, Mark Avivi, Irit Luttwak, Efrat Cohen, Yael C. Br J Haematol Haematological Malignancy–Clinical Belantamab mafodotin, an immuno‐conjugate targeting B‐cell maturation antigen, showed single‐agent activity in phase 1 and 2 studies, and was recently approved for heavily pretreated relapsed/refractory multiple myeloma (RRMM) patients. Real‐world data and long‐term follow‐up are scarce. We conducted a multisite retrospective study aimed to assess safety and efficacy of belantamab mafodotin monotherapy administered via the GSK expanded access compassionate care programme. One‐hundred and six RRMM patients were treated with belantamab mafodotin between July 2019 and March 2021. The median age was 69.4 years. Patients were heavily pretreated with a median of six (range 2–11) prior therapy lines. Major adverse effects included ocular toxicity (keratopathy 68.4%, grade ≥3: 40.5%; blurred vision 36.8%, grade ≥3: 6.3%), thrombocytopenia (27.4%, grade ≥3: 17.9%) and infections (11.3%, grade ≥3: 7.5%). Median follow‐up time was 11.9 [95% confidence interval (CI) 10.0–13.8] months. Overall response rate was 45.5%. Median progression‐free survival was 4.7 (95% CI 3.5–5.9) months in the entire cohort and 8.8 (95% CI 6.6–10.9) months among responders. Median overall survival was 14.5 (95% CI 9.5–19.6) months, and not reached for responders. To conclude, in a real‐world setting, belantamab mafodotin monotherapy showed efficacy comparable with the prospective clinical trials, with a tolerable toxicity profile. John Wiley and Sons Inc. 2022-10-07 2023-01 /pmc/articles/PMC10091809/ /pubmed/36205375 http://dx.doi.org/10.1111/bjh.18479 Text en © 2022 The Authors. British Journal of Haematology published by British Society for Haematology and John Wiley & Sons Ltd. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ (https://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.
spellingShingle Haematological Malignancy–Clinical
Shragai, Tamir
Magen, Hila
Lavi, Noa
Gatt, Moshe
Trestman, Svetlana
Zektser, Miri
Ganzel, Chezi
Jarchowsky, Osnat
Berger, Tamar
Tadmor, Tamar
Leiba, Merav
Hertzog‐Tzarfaty, Katrin
Horowitz, Netanel
Shapira, Michael
Varssano, David
Berger, Yoav
Frenkel, Shahar
Krauthammer, Mark
Avivi, Irit
Luttwak, Efrat
Cohen, Yael C.
Real‐world experience with belantamab mafodotin therapy for relapsed/refractory multiple myeloma: A multicentre retrospective study
title Real‐world experience with belantamab mafodotin therapy for relapsed/refractory multiple myeloma: A multicentre retrospective study
title_full Real‐world experience with belantamab mafodotin therapy for relapsed/refractory multiple myeloma: A multicentre retrospective study
title_fullStr Real‐world experience with belantamab mafodotin therapy for relapsed/refractory multiple myeloma: A multicentre retrospective study
title_full_unstemmed Real‐world experience with belantamab mafodotin therapy for relapsed/refractory multiple myeloma: A multicentre retrospective study
title_short Real‐world experience with belantamab mafodotin therapy for relapsed/refractory multiple myeloma: A multicentre retrospective study
title_sort real‐world experience with belantamab mafodotin therapy for relapsed/refractory multiple myeloma: a multicentre retrospective study
topic Haematological Malignancy–Clinical
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10091809/
https://www.ncbi.nlm.nih.gov/pubmed/36205375
http://dx.doi.org/10.1111/bjh.18479
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