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Elranatamab in relapsed or refractory multiple myeloma: phase 2 MagnetisMM-3 trial results

Elranatamab is a humanized B-cell maturation antigen (BCMA)-CD3 bispecific antibody. In the ongoing phase 2 MagnetisMM-3 trial, patients with relapsed or refractory multiple myeloma received subcutaneous elranatamab once weekly after two step-up priming doses. After six cycles, persistent responders...

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Autores principales: Lesokhin, Alexander M., Tomasson, Michael H., Arnulf, Bertrand, Bahlis, Nizar J., Miles Prince, H., Niesvizky, Ruben, Rodrίguez-Otero, Paula, Martinez-Lopez, Joaquin, Koehne, Guenther, Touzeau, Cyrille, Jethava, Yogesh, Quach, Hang, Depaus, Julien, Yokoyama, Hisayuki, Gabayan, Afshin Eli, Stevens, Don A., Nooka, Ajay K., Manier, Salomon, Raje, Noopur, Iida, Shinsuke, Raab, Marc-Steffen, Searle, Emma, Leip, Eric, Sullivan, Sharon T., Conte, Umberto, Elmeliegy, Mohamed, Czibere, Akos, Viqueira, Andrea, Mohty, Mohamad
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Nature Publishing Group US 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10504075/
https://www.ncbi.nlm.nih.gov/pubmed/37582952
http://dx.doi.org/10.1038/s41591-023-02528-9
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author Lesokhin, Alexander M.
Tomasson, Michael H.
Arnulf, Bertrand
Bahlis, Nizar J.
Miles Prince, H.
Niesvizky, Ruben
Rodrίguez-Otero, Paula
Martinez-Lopez, Joaquin
Koehne, Guenther
Touzeau, Cyrille
Jethava, Yogesh
Quach, Hang
Depaus, Julien
Yokoyama, Hisayuki
Gabayan, Afshin Eli
Stevens, Don A.
Nooka, Ajay K.
Manier, Salomon
Raje, Noopur
Iida, Shinsuke
Raab, Marc-Steffen
Searle, Emma
Leip, Eric
Sullivan, Sharon T.
Conte, Umberto
Elmeliegy, Mohamed
Czibere, Akos
Viqueira, Andrea
Mohty, Mohamad
author_facet Lesokhin, Alexander M.
Tomasson, Michael H.
Arnulf, Bertrand
Bahlis, Nizar J.
Miles Prince, H.
Niesvizky, Ruben
Rodrίguez-Otero, Paula
Martinez-Lopez, Joaquin
Koehne, Guenther
Touzeau, Cyrille
Jethava, Yogesh
Quach, Hang
Depaus, Julien
Yokoyama, Hisayuki
Gabayan, Afshin Eli
Stevens, Don A.
Nooka, Ajay K.
Manier, Salomon
Raje, Noopur
Iida, Shinsuke
Raab, Marc-Steffen
Searle, Emma
Leip, Eric
Sullivan, Sharon T.
Conte, Umberto
Elmeliegy, Mohamed
Czibere, Akos
Viqueira, Andrea
Mohty, Mohamad
author_sort Lesokhin, Alexander M.
collection PubMed
description Elranatamab is a humanized B-cell maturation antigen (BCMA)-CD3 bispecific antibody. In the ongoing phase 2 MagnetisMM-3 trial, patients with relapsed or refractory multiple myeloma received subcutaneous elranatamab once weekly after two step-up priming doses. After six cycles, persistent responders switched to biweekly dosing. Results from cohort A, which enrolled patients without prior BCMA-directed therapy (n = 123) are reported. The primary endpoint of confirmed objective response rate (ORR) by blinded independent central review was met with an ORR of 61.0% (75/123); 35.0% ≥complete response. Fifty responders switched to biweekly dosing, and 40 (80.0%) improved or maintained their response for ≥6 months. With a median follow-up of 14.7 months, median duration of response, progression-free survival and overall survival (secondary endpoints) have not been reached. Fifteen-month rates were 71.5%, 50.9% and 56.7%, respectively. Common adverse events (any grade; grade 3–4) included infections (69.9%, 39.8%), cytokine release syndrome (57.7%, 0%), anemia (48.8%, 37.4%), and neutropenia (48.8%, 48.8%). With biweekly dosing, grade 3–4 adverse events decreased from 58.6% to 46.6%. Elranatamab induced deep and durable responses with a manageable safety profile. Switching to biweekly dosing may improve long-term safety without compromising efficacy. ClinicalTrials.gov identifier: NCT04649359.
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spelling pubmed-105040752023-09-17 Elranatamab in relapsed or refractory multiple myeloma: phase 2 MagnetisMM-3 trial results Lesokhin, Alexander M. Tomasson, Michael H. Arnulf, Bertrand Bahlis, Nizar J. Miles Prince, H. Niesvizky, Ruben Rodrίguez-Otero, Paula Martinez-Lopez, Joaquin Koehne, Guenther Touzeau, Cyrille Jethava, Yogesh Quach, Hang Depaus, Julien Yokoyama, Hisayuki Gabayan, Afshin Eli Stevens, Don A. Nooka, Ajay K. Manier, Salomon Raje, Noopur Iida, Shinsuke Raab, Marc-Steffen Searle, Emma Leip, Eric Sullivan, Sharon T. Conte, Umberto Elmeliegy, Mohamed Czibere, Akos Viqueira, Andrea Mohty, Mohamad Nat Med Article Elranatamab is a humanized B-cell maturation antigen (BCMA)-CD3 bispecific antibody. In the ongoing phase 2 MagnetisMM-3 trial, patients with relapsed or refractory multiple myeloma received subcutaneous elranatamab once weekly after two step-up priming doses. After six cycles, persistent responders switched to biweekly dosing. Results from cohort A, which enrolled patients without prior BCMA-directed therapy (n = 123) are reported. The primary endpoint of confirmed objective response rate (ORR) by blinded independent central review was met with an ORR of 61.0% (75/123); 35.0% ≥complete response. Fifty responders switched to biweekly dosing, and 40 (80.0%) improved or maintained their response for ≥6 months. With a median follow-up of 14.7 months, median duration of response, progression-free survival and overall survival (secondary endpoints) have not been reached. Fifteen-month rates were 71.5%, 50.9% and 56.7%, respectively. Common adverse events (any grade; grade 3–4) included infections (69.9%, 39.8%), cytokine release syndrome (57.7%, 0%), anemia (48.8%, 37.4%), and neutropenia (48.8%, 48.8%). With biweekly dosing, grade 3–4 adverse events decreased from 58.6% to 46.6%. Elranatamab induced deep and durable responses with a manageable safety profile. Switching to biweekly dosing may improve long-term safety without compromising efficacy. ClinicalTrials.gov identifier: NCT04649359. Nature Publishing Group US 2023-08-15 2023 /pmc/articles/PMC10504075/ /pubmed/37582952 http://dx.doi.org/10.1038/s41591-023-02528-9 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits 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 license, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons license 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 license, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) .
spellingShingle Article
Lesokhin, Alexander M.
Tomasson, Michael H.
Arnulf, Bertrand
Bahlis, Nizar J.
Miles Prince, H.
Niesvizky, Ruben
Rodrίguez-Otero, Paula
Martinez-Lopez, Joaquin
Koehne, Guenther
Touzeau, Cyrille
Jethava, Yogesh
Quach, Hang
Depaus, Julien
Yokoyama, Hisayuki
Gabayan, Afshin Eli
Stevens, Don A.
Nooka, Ajay K.
Manier, Salomon
Raje, Noopur
Iida, Shinsuke
Raab, Marc-Steffen
Searle, Emma
Leip, Eric
Sullivan, Sharon T.
Conte, Umberto
Elmeliegy, Mohamed
Czibere, Akos
Viqueira, Andrea
Mohty, Mohamad
Elranatamab in relapsed or refractory multiple myeloma: phase 2 MagnetisMM-3 trial results
title Elranatamab in relapsed or refractory multiple myeloma: phase 2 MagnetisMM-3 trial results
title_full Elranatamab in relapsed or refractory multiple myeloma: phase 2 MagnetisMM-3 trial results
title_fullStr Elranatamab in relapsed or refractory multiple myeloma: phase 2 MagnetisMM-3 trial results
title_full_unstemmed Elranatamab in relapsed or refractory multiple myeloma: phase 2 MagnetisMM-3 trial results
title_short Elranatamab in relapsed or refractory multiple myeloma: phase 2 MagnetisMM-3 trial results
title_sort elranatamab in relapsed or refractory multiple myeloma: phase 2 magnetismm-3 trial results
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10504075/
https://www.ncbi.nlm.nih.gov/pubmed/37582952
http://dx.doi.org/10.1038/s41591-023-02528-9
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