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http://hdl.handle.net/11434/2021
Title: | Efficacy and safety of weekly carfilzomib (70 mg/m2), dexamethasone, and daratumumab (KdD70)is comparable to twice-weekly KdD56 while being a more convenient dosing option: a cross-study comparison of the CANDOR and EQUULEUS studies |
Epworth Authors: | Prince, Miles |
Other Authors: | Leleu, Xavier Beksac, Meral Chou, Takaaki Dimopoulos, Meletios Yoon, Sung-Soo Pour, Ludek Shelekhova, Tatiana Chari, Ajai Khurana, Monica Zhang, Jianqi Obreja, Mihaela Qi, Ming Oriol, Albert Siegel, David |
Keywords: | Carfilzomib Daratumumab Multiple Myeloma Dexamethasone (KdD) Relapsed/Refractory Multiple Myeloma Randomized Phase 3 CANDOR Study Phase 1 b EQUULEUS Study Immunomodulatory Imide Drugs (IMiDs) Lenalidomide Carfilzomib Overall Response Rate (ORR) Minimal Residual Disease (MRD) Progression-Free Survival (PFS) Inverse Probability of Treatment Weighting (IPTW) Lenalidomide-Free Regimen Convenient Dosing Option EQUULEUS studies CASTOR study Hazard Ratios Independent Review Committee (IRC) Kaplan-Meier Epworth Centre for Immunotherapies and Snowdome Laboratories Molecular Oncology and Cancer Immunology Cancer Services Clinical Institute, Epworth HealthCare, Victoria, Australia |
Issue Date: | Oct-2020 |
Publisher: | National Center for Biotechnology Information (NCBI) |
Citation: | Leuk Lymphoma. 2021 Feb;62(2):358-367. |
Abstract: | The regimen of carfilzomib, daratumumab, and dexamethasone (KdD) shows activity in patients with relapsed/refractory multiple myeloma. KdD at the twice-weekly 56 mg/m2 carfilzomib dose (KdD56) was used in the randomized phase 3 CANDOR study (NCT03158688), whereas KdD at the once-weekly 70 mg/m2 carfilzomib dose (KdD70) was used in the phase 1 b EQUULEUS study (NCT01998971). We analyzed efficacy data from comparable CANDOR and EQUULEUS patients using inverse probability of treatment weighting (IPTW)–adjusted models. These weights were calculated from propensity scores derived to balance prespecified baseline covariates. The side-by-side and adjusted comparisons showed similar efficacy for overall response rates and progression-free survival in the two groups, with a series of sensitivity analyses showing consistent findings. Safety data were generally consistent with the known safety profiles of each individual drug. Once-weekly KdD70 is comparable to twice-weekly KdD56 in terms of efficacy and safety while being a more convenient dosing option. In conclusion, this cross-study analysis showed that once-weekly KdD70 in the EQUULEUS study is comparable to the twice-weekly KdD56 regimen used in the pivotal phase 3 CANDOR trial in terms of efficacy and safety. The weekly KdD70 dosing option addresses an important need for patients by providing a more convenient lenalidomide-free regimen that may encourage adherence and potentially lead to improved outcomes for patients. |
URI: | http://hdl.handle.net/11434/2021 |
DOI: | 10.1080/10428194.2020.1832672 |
PubMed URL: | https://pubmed.ncbi.nlm.nih.gov/33112184/ |
ISSN: | 1042-8194 1029-2403 |
Journal Title: | Leukemia & Lymphoma |
Type: | Journal Article |
Affiliated Organisations: | Service d'Hématologie et Thérapie cellulaire, CHU and Inserm, Poitiers, France Department of Hematology, Ankara University, Ankara, Turkey Department of Internal Medicine, Niigata Cancer Center Hospital, Niigata, Japan Hematology and Medical Oncology, Department of Clinical Therapeutics, National and Kapodistrian University of Athens School of Medicine, Athens, Greece Department of Internal Medicine, Seoul National University, Seoul, South Korea Epworth Healthcare and Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Australia Department of Internal Medicine, Hematology and Oncology, University Hospital Brno, Brno, Czech Republic Clinic of Professional Pathology, Saratov, Russian Federation Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA Clinical Development, Oncology, Amgen Inc., Thousand Oaks, CA, USA Global Biostatistical Science, Amgen Inc., Thousand Oaks, CA, USA. Hematology and Oncology, Janssen Research and Development, LLC, Spring House, PA, USA Institut Català d'Oncologia and Josep Carreras Research Leukaemia Institute, Hospital Germans Trias i Pujol, Barcelona, Spain John Theurer Cancer Center, Hackensack University Medical Center, Hackensack, NJ, USA |
Type of Clinical Study or Trial: | Cross-Study Analysis |
Appears in Collections: | Cancer Services MOCI |
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