دورية أكاديمية

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

التفاصيل البيبلوغرافية
العنوان: Elranatamab in relapsed or refractory multiple myeloma: phase 2 MagnetisMM-3 trial results.
المؤلفون: Lesokhin AM; Division of Hematology and Oncology, Memorial Sloan Kettering Cancer Center/Weill Cornell Medical College, New York City, NY, USA. lesokhia@mskcc.org., Tomasson MH; Department of Internal Medicine, University of Iowa, Iowa City, IA, USA., Arnulf B; Hôpital Saint-Louis, Paris, France., Bahlis NJ; Arnie Charbonneau Cancer Institute, University of Calgary, Calgary, Alberta, Canada., Miles Prince H; Epworth Healthcare and University of Melbourne, Melbourne, Victoria, Australia., Niesvizky R; Weill Cornell Medical College/New York Presbyterian Hospital, New York City, NY, USA., Rodrίguez-Otero P; Clinica Universidad de Navarra, Madrid, Spain., Martinez-Lopez J; Hospital Universitario 12 de Octubre, Madrid, Spain., Koehne G; Miami Cancer Institute, Miami, FL, USA., Touzeau C; University Hospital of Nantes, Nantes, France., Jethava Y; Indiana Blood & Marrow Transplant, Indianapolis, IN, USA., Quach H; University of Melbourne, St. Vincent's Hospital Melbourne, Melbourne, Victoria, Australia., Depaus J; Université Catholique de Louvain, CHU UCL Namur, Yvoir, Belgium., Yokoyama H; Tohoku University Graduate School of Medicine, Sendai, Japan., Gabayan AE; Beverly Hills Cancer Center, Beverly Hills, CA, USA., Stevens DA; Norton Cancer Center, Louisville, KY, USA., Nooka AK; Winship Cancer Institute, Atlanta, GA, USA., Manier S; Lille University Hospital and INSERM UMR-S1277, Lille, France., Raje N; Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA, USA., Iida S; Department of Hematology & Oncology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan., Raab MS; Heidelberg Myeloma Center, Department of Hematology/Oncology, Heidelberg University Hospital, Heidelberg, Germany., Searle E; The Christie Hospital, The University of Manchester, Manchester, UK., Leip E; Pfizer Inc, Cambridge, MA, USA., Sullivan ST; Pfizer Inc, Cambridge, MA, USA., Conte U; Pfizer Inc, New York, NY, USA., Elmeliegy M; Pfizer Inc, San Diego, CA, USA., Czibere A; Pfizer Inc, New York, NY, USA., Viqueira A; Pfizer SLU, Madrid, Spain., Mohty M; Sorbonne University, Hôpital Saint-Antoine, and INSERM UMRs938, Paris, France.
المصدر: Nature medicine [Nat Med] 2023 Sep; Vol. 29 (9), pp. 2259-2267. Date of Electronic Publication: 2023 Aug 15.
نوع المنشور: Clinical Trial, Phase II; Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't
اللغة: English
بيانات الدورية: Publisher: Nature Publishing Company Country of Publication: United States NLM ID: 9502015 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1546-170X (Electronic) Linking ISSN: 10788956 NLM ISO Abbreviation: Nat Med Subsets: MEDLINE
أسماء مطبوعة: Publication: New York Ny : Nature Publishing Company
Original Publication: New York, NY : Nature Pub. Co., [1995-
مواضيع طبية MeSH: Multiple Myeloma*/drug therapy, Humans ; B-Cell Maturation Antigen ; Progression-Free Survival ; Remission Induction
مستخلص: 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 .
(© 2023. The Author(s).)
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معلومات مُعتمدة: P30 CA008748 United States CA NCI NIH HHS; P30 CA086862 United States CA NCI NIH HHS
سلسلة جزيئية: ClinicalTrials.gov NCT04649359
المشرفين على المادة: 0 (B-Cell Maturation Antigen)
تواريخ الأحداث: Date Created: 20230815 Date Completed: 20230918 Latest Revision: 20231122
رمز التحديث: 20231215
مُعرف محوري في PubMed: PMC10504075
DOI: 10.1038/s41591-023-02528-9
PMID: 37582952
قاعدة البيانات: MEDLINE
الوصف
تدمد:1546-170X
DOI:10.1038/s41591-023-02528-9