Teclistamab plus Daratumumab in Relapsed or Refractory Multiple Myeloma
Teclistamab plus Daratumumab in Relapsed or Refractory Multiple Myeloma
Efficacy and safety of daratumumab in intermediate/high-risk smoldering multiple myeloma: final analysis of CENTAURUS
Author(s): Ola Landgren1;Ajai Chari2;Yael C. Cohen3;Andrew Spencer4;Peter M. Voorhees5;Irwindeep Sandhu6;Matthew W. Jenner7;Dean Smith8;Michele Cavo9;Niels W. C. J. van de Donk10;Meral Beksac11;Philippe Moreau12;Hartmut Goldschmidt13;Diego Vieyra14;Linlin Sha15;Liang Li15;Els Rousseau16;Robyn Dennis17;Robin Carson14;Craig C. Hofmeister18
Source: Blood (2025) 145 (15): 1658–1669.
Dr. Maen Hussein's Thoughts
Daratumumab continued to demonstrate single-agent clinical activity in patients with intermediate- or high-risk smoldering myeloma. No new safety concerns were observed after extended follow-up of approximately seven years, highlighting the tolerability of daratumumab. Will need phase III trials.
ABSTRACT
Early intervention in smoldering multiple myeloma (SMM) may delay progression to MM. Here, we present the final analysis of the phase 2 CENTAURUS study. In total, 123 patients with intermediate/high-risk SMM were randomized to IV daratumumab 16 mg/kg after a long-intense (n = 41), intermediate (n = 41), or short-intense (n = 41) dosing schedule. At a combined median follow-up of 85.2 months, in the long-intense, intermediate, and short-intense arms complete response or better rates were 4.9%, 9.8%, and 0%; overall response rates were 58.5%, 53.7%, and 37.5%; progressive disease/death rates were 0.096, 0.102, and 0.109 (P < .0001 for all arms); and median progression-free survival was not reached, 84.4, and 74.1 months, respectively. Median overall survival was not reached in any arm. Thirty-six patients in the long-intense or intermediate arms continued daratumumab in an optional extension phase after completing 20 cycles of per-protocol treatment. The median duration of study treatment was 44.0 (range, 1.0-91.6), 35.2 (range, 1.9-90.6), and 1.6 (range, 0.1-1.9) months in the long-intense, intermediate, and short-intense arms, respectively. No new safety signals were observed. With extended follow-up (median, ∼7 years), these data highlight the tolerability of daratumumab and support ongoing trials investigating daratumumab as an early intervention for SMM. This trial was registered at www.ClinicalTrials.gov as #NCT02316106.
Author Affiliations
1Division of Myeloma, Department of Medicine, Sylvester Comprehensive Cancer Center at University of Miami, Miami, FL;2Center of Excellence for Multiple Myeloma, Icahn School of Medicine at Mount Sinai, New York, NY;3Department of Hematology, Tel Aviv Sourasky (Ichilov) Medical Center, Faculty of Medicine and Health Sciences, Tel Aviv University, Tel Aviv, Israel;4Department of Clinical Haematology, Malignant Haematology, and Stem Cell Transplantation Service, Alfred Health-Monash University, Melbourne, Australia;5Department of Hematology and Oncology, Levine Cancer Institute, Atrium Health Wake Forest University School of Medicine, Charlotte, NC;6Department of Oncology, Cross Cancer Institute, University of Alberta, Edmonton, AB, Canada;7Department of Haematology, University Hospital Southampton, Southampton, United Kingdom;8Department of Haematology, Translational Medical Sciences, University of Nottingham, Nottingham, United Kingdom;9Department of Specialized, Diagnostic, and Experimental Medicine, Istituto di Ricovero e Cura a Carattere Scientifico Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia “Seràgnoli,” Università di Bologna, Bologna, Italy;10Department of Hematology, Amsterdam University Medical Center, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands;11Department of Hematology, Ankara University, Ankara, Turkey;12Hematology Department, University Hospital Hôtel-Dieu, Nantes, France;13German-speaking Myeloma Multicenter Group and Internal Medicine V, University Hospital Heidelberg, Heidelberg, Germany;14Janssen Research & Development, LLC, Spring House, PA;15Janssen Research & Development, LLC, Shanghai, China;16Janssen Research & Development, LLC, Beerse, Belgium;17Janssen Research & Development, LLC, Raritan, NJ;18Department of Hematology and Medical Oncology, Winship Cancer Institute of Emory University, Atlanta, GARelated Articles
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