Indatuximab Ravtansine (BT062) Monotherapy in Patients With Relapsed and/or Refractory Multiple Myeloma.


Journal

Clinical lymphoma, myeloma & leukemia
ISSN: 2152-2669
Titre abrégé: Clin Lymphoma Myeloma Leuk
Pays: United States
ID NLM: 101525386

Informations de publication

Date de publication:
06 2019
Historique:
received: 02 11 2018
accepted: 11 02 2019
pubmed: 2 4 2019
medline: 28 7 2020
entrez: 2 4 2019
Statut: ppublish

Résumé

Indatuximab ravtansine (BT062) is an antibody-drug conjugate that binds to CD138, which is overexpressed on multiple myeloma (MM) cells. We report from 2 clinical studies of patients with relapsed and/or refractory MM previously treated with an immunomodulatory drug and a proteasome inhibitor. Single- and multi-dosing schedules were investigated to define dose-limiting toxicities, maximum tolerated dose (MTD), recommended phase II dose, and to describe safety, efficacy, and pharmacokinetics. In the first-in-human study, indatuximab ravtansine was administered to 32 patients on day 1 of each 21-day cycle. The MTD was 160 mg/m Our data support further investigation of indatuximab ravtansine as part of a combination regimen for relapsed and/or refractory MM.

Sections du résumé

BACKGROUND
Indatuximab ravtansine (BT062) is an antibody-drug conjugate that binds to CD138, which is overexpressed on multiple myeloma (MM) cells.
PATIENTS AND METHODS
We report from 2 clinical studies of patients with relapsed and/or refractory MM previously treated with an immunomodulatory drug and a proteasome inhibitor. Single- and multi-dosing schedules were investigated to define dose-limiting toxicities, maximum tolerated dose (MTD), recommended phase II dose, and to describe safety, efficacy, and pharmacokinetics.
RESULTS
In the first-in-human study, indatuximab ravtansine was administered to 32 patients on day 1 of each 21-day cycle. The MTD was 160 mg/m
CONCLUSION
Our data support further investigation of indatuximab ravtansine as part of a combination regimen for relapsed and/or refractory MM.

Identifiants

pubmed: 30930134
pii: S2152-2650(18)31566-0
doi: 10.1016/j.clml.2019.02.006
pii:
doi:

Substances chimiques

Antineoplastic Agents, Immunological 0
Immunoconjugates 0
indatuximab ravtansine 0
Maytansine 14083FR882

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

372-380

Informations de copyright

Copyright © 2019. Published by Elsevier Inc.

Auteurs

Sundar Jagannath (S)

Icahn School of Medicine at Mount Sinai, New York, NY. Electronic address: sundar.jagannath@mountsinai.org.

Leonard T Heffner (LT)

Department of Hematology and Medical Oncology, Emory University School of Medicine, Atlanta, GA.

Sikander Ailawadhi (S)

Division of Hematology-Oncology, Mayo Clinic, Jacksonville, FL.

Nikhil C Munshi (NC)

Jerome Lipper Multiple Myeloma Center, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA.

Todd M Zimmerman (TM)

University of Chicago Medical Center, Chicago, IL.

Jacalyn Rosenblatt (J)

Beth Israel Deaconess Medical Center, Boston, MA.

Sagar Lonial (S)

Department of Hematology and Medical Oncology, Emory University School of Medicine, Atlanta, GA.

Asher Chanan-Khan (A)

Division of Hematology-Oncology, Mayo Clinic, Jacksonville, FL.

Markus Ruehle (M)

Biotest AG, Dreieich, Germany.

Faiza Rharbaoui (F)

Biotest AG, Dreieich, Germany.

Thomas Haeder (T)

Biotest AG, Dreieich, Germany.

Andrea Wartenberg-Demand (A)

Biotest AG, Dreieich, Germany.

Kenneth C Anderson (KC)

Jerome Lipper Multiple Myeloma Center, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA.

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Classifications MeSH