Haematologica (Dec 2018)
Daratumumab plus bortezomib and dexamethasone versus bortezomib and dexamethasone in relapsed or refractory multiple myeloma: updated analysis of CASTOR
- Andrew Spencer,
- Suzanne Lentzsch,
- Katja Weisel,
- Hervé Avet-Loiseau,
- Tomer M. Mark,
- Ivan Spicka,
- Tamas Masszi,
- Birgitta Lauri,
- Mark-David Levin,
- Alberto Bosi,
- Vania Hungria,
- Michele Cavo,
- Je-Jung Lee,
- Ajay K. Nooka,
- Hang Quach,
- Cindy Lee,
- Wolney Barreto,
- Paolo Corradini,
- Chang-Ki Min,
- Emma C. Scott,
- Asher A. Chanan-Khan,
- Noemi Horvath,
- Marcelo Capra,
- Meral Beksac,
- Roberto Ovilla,
- Jae-Cheol Jo,
- Ho-Jin Shin,
- Pieter Sonneveld,
- David Soong,
- Tineke Casneuf,
- Christopher Chiu,
- Himal Amin,
- Ming Qi,
- Piruntha Thiyagarajah,
- A. Kate Sasser,
- Jordan M. Schecter,
- Maria-Victoria Mateos
Affiliations
- Andrew Spencer
- Malignant Haematology and Stem Cell Transplantation Service, Alfred Health-Monash University, Melbourne, Australia
- Suzanne Lentzsch
- Division of Hematology/Oncology, Columbia University, New York, NY, USA
- Katja Weisel
- Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II, Tübingen, Germany
- Hervé Avet-Loiseau
- Unite de Genomique du Myelome, CHU Rangueil, Toulouse, France
- Tomer M. Mark
- Department of Medicine, University of Colorado, Aurora, CO, USA
- Ivan Spicka
- Clinical Department of Haematology, 1st Medical Department, Charles University in Prague, Czech Republic
- Tamas Masszi
- Department of Haematology and Stem Cell Transplantation, St László Hospital, 3rd Department of Internal Medicine, Semmelweis University, Budapest, Hungary
- Birgitta Lauri
- Department of Hematology, Sunderbyn Hospital, Luleå, Sweden
- Mark-David Levin
- Albert Schweitzer Hospital Department of Internal Medicine, Dordrecht, the Netherlands
- Alberto Bosi
- Department of Hematology, Careggi Hospital and University of Florence, Italy
- Vania Hungria
- Irmandade Da Santa Casa De Misericordia De São Paulo, Brazil
- Michele Cavo
- “Seràgnoli” Institute of Hematology, Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, Italy
- Je-Jung Lee
- Department of Hematology-Oncology, Chonnam National University Hwasun Hospital, Jeollanamdo, South Korea
- Ajay K. Nooka
- Winship Cancer Institute, Emory University, Atlanta, GA, USA
- Hang Quach
- St. Vincent’s Hospital, University of Melbourne, Australia
- Cindy Lee
- Royal Adelaide Hospital, North Terrace, Australia
- Wolney Barreto
- Hospital Santa Marcelina, São Paulo, Brazil
- Paolo Corradini
- Fondazione IRCCS Instituto Nazionale dei Tumori, University of Milan, Italy
- Chang-Ki Min
- Seoul St. Mary’s Hospital, South Korea
- Emma C. Scott
- Oregon Health & Science University, Portland, OR, USA
- Asher A. Chanan-Khan
- Mayo Clinic Florida, Jacksonville, FL, USA;
- Noemi Horvath
- Royal Adelaide Hospital, North Terrace, Australia
- Marcelo Capra
- Instituto do Cancer-Hospital Mae de Deus, Porto Alegre, Brazil
- Meral Beksac
- Ankara University, Turkey
- Roberto Ovilla
- Hospital Angeles Lomas, Naucalpan de Juárez y alrededores, México
- Jae-Cheol Jo
- Ulsan University Hospital, South Korea
- Ho-Jin Shin
- Division of Hematology-Oncology, Department of Internal Medicine, School of Medicine, Medical Research Institute, Pusan National University Hospital, Busan, South Korea
- Pieter Sonneveld
- Erasmus Medical Center, Rotterdam, the Netherlands
- David Soong
- Janssen Research & Development, LLC, Spring House, PA, USA
- Tineke Casneuf
- Janssen Research & Development, Beerse, Belgium
- Christopher Chiu
- Janssen Research & Development, LLC, Spring House, PA, USA
- Himal Amin
- Janssen Research & Development, LLC, Raritan, NJ, USA
- Ming Qi
- Janssen Research & Development, LLC, Spring House, PA, USA
- Piruntha Thiyagarajah
- Janssen Research & Development, High Wycombe, UK
- A. Kate Sasser
- Genmab US, Inc, Princeton, NJ, USA
- Jordan M. Schecter
- Janssen Research & Development, LLC, Raritan, NJ, USA
- Maria-Victoria Mateos
- University Hospital of Salamanca/IBSAL, Spain
- DOI
- https://doi.org/10.3324/haematol.2018.194118
- Journal volume & issue
-
Vol. 103,
no. 12
Abstract
Daratumumab, a CD38 human monoclonal antibody, demonstrated significant clinical activity in combination with bortezomib and dexamethasone versus bortezomib and dexamethasone alone in the primary analysis of CASTOR, a phase 3 study in relapsed and/or refractory multiple myeloma. A post hoc analysis based on treatment history and longer follow up is presented. After 19.4 (range: 0-27.7) months of median follow up, daratumumab plus bortezomib and dexamethasone prolonged progression-free survival (median: 16.7 versus 7.1 months; hazard ratio, 0.31; 95% confidence interval, 0.24-0.39; P2.5-fold higher with daratumumab across subgroups. The safety profile of daratumumab plus bortezomib and dexamethasone remained consistent with longer follow up. Daratumumab plus bortezomib and dexamethasone demonstrated significant clinical activity across clinically relevant subgroups and provided the greatest benefit to patients treated at first relapse. Trial registration: clinicaltrials.gov identifier: 02136134.