15 Dec Multiple Myeloma: Phase 3 Study of DARZALEX + VMP Reduced Risk of Disease Progression and Mortality
MedicalResearch.com Interview with:
Dr. Meletios A. Dimopoulos MD
Professor and Chairman
Department of Clinical Therapeutics
University Athens School of Medicine
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Updated data from the Phase 3 POLLUX trials showed DARZALEX, in combination with lenalidomide and dexamethasone, reduced the risk of disease progression or death by 56 percent, compared to lenalidomide and dexamethasone alone (Hazard Ratio [HR]=0.44; 95 percent CI [0.34-0.55], p<0.0001). After a median follow-up of 32.9 months, the median progression-free survival (PFS) in the DARZALEX arm has not been reached, compared with a median PFS of 17.5 months for patients who received lenalidomide and dexamethasone alone.
DARZALEX in combination with lenalidomide and dexamethasone also significantly increased the overall response rate (ORR) compared to lenalidomide and dexamethasone alone (93 percent vs. 76 percent, p<0.0001), including rates of complete response (CR) or better (55 percent vs. 23 percent, p<0.0001). DARZALEX also showed significantly higher (>3-fold) MRD-negative rates compared to lenalidomide and dexamethasone alone. These data were featured as an oral presentation (Abstract #739) at the 59th American Society of Hematology (ASH) Annual Meeting in early December.
MedicalResearch.com: What should readers take away from your report?
Response: In combination with standard of care regimens, DARZALEX continued to improve progression-free survival for patients with relapsed or refractory multiple myeloma. These long-term data show that DARZALEX delivered deep and durable responses over time, with patients continuing to benefit throughout the course of combination treatment.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: In the multiple myeloma disease landscape, there is still an unmet need. Updated findings from the POLLUX trial presented at ASH continue to support the use of this DARZALEX combination therapy in patients with relapsed or refractory multiple myeloma. More patients receiving DARZALEX achieved MRD negativity compared to lenalidomide and dexamethasone alone, with MRD negativity occurring more rapidly with DARZALEX and increasing over time. DARZALEX in combination with lenalidomide and dexamethasone did not negatively impact outcomes of subsequent therapy, and the safety profile remained unchanged with longer follow-up.
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Citation: ASH 2017 Abstract
LBA-4 Phase 3 Randomized Study of Daratumumab Plus Bortezomib, Melphalan, and Prednisone (D-VMP) Versus Bortezomib, Melphalan, and Prednisone (VMP) in Newly Diagnosed Multiple Myeloma (NDMM) Patients (Pts) Ineligible for Transplant (ALCYONE)
Tuesday, December 12, 2017, 7:30 AM-9:00 AM
Daratumumab plus Bortezomib, Melphalan, and Prednisone for Untreated Myeloma
María-Victoria Mateos, M.D., Meletios A. Dimopoulos, M.D., Michele Cavo, M.D., Kenshi Suzuki, M.D., Andrzej Jakubowiak, M.D., Stefan Knop, M.D., Chantal Doyen, M.D., Paulo Lucio, M.D., Zsolt Nagy, M.D., Polina Kaplan, M.D., Ludek Pour, M.D., Mark Cook, M.D., Sebastian Grosicki, M.D., Andre Crepaldi, M.D., Anna M. Liberati, M.D., Philip Campbell, M.D., Tatiana Shelekhova, M.D., Sung-Soo Yoon, M.D., Genadi Iosava, Ph.D., Tomoaki Fujisaki, M.D., Mamta Garg, M.D., Christopher Chiu, Ph.D., Jianping Wang, Ph.D., Robin Carson, M.D., Wendy Crist, B.A., William Deraedt, M.Sc., Huong Nguyen, M.D., Ming Qi, M.D., and Jesus San-Miguel, M.D., for the ALCYONE Trial Investigators*
December 12, 2017DOI: 10.1056/NEJMoa1714678
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