UPDATED ANALYSIS OF DARATUMUMAB PLUS LENALIDOMIDE AND DEXAMETHASONE (D-RD)
POSTER 35
VERSUS LENALIDOMIDE AND DEXAMETHASONE (RD) IN PATIENTS WITH TRANSPLANT-INELIGIBLE
NEWLY DIAGNOSED MULTIPLE MYELOMA (NDMM): THE PHASE 3 MAIA STUDY
Aurore Perrot1, Thierry Facon2, Saad Z. Usmani3, Torben Plesner4, Robert Z. Orlowski5, Cyrille Touzeau6,
Supratik Basu7, Nizar J. Bahlis8, Hartmut Goldschmidt9, Michael O'Dwyer10, Christopher P. Venner11,
Katja Weisel12, Cyrille Hulin13, Lionel Karlin14, Meir Preis15, Annemiek Broyl16, William Renwick17,
Markus Hansson18, Maria Krevvata19, Jianping Wang20, Rian Van Rampelbergh21, Jon Ukropec22, Clarissa
M. Uhlar19, Rachel Kobos20 and Shaji Kumar23
(1)CHU de Toulouse, IUCT-O, Université de Toulouse, UPS, Service d’Hématologie, Toulouse, France
(2)University of Lille, CHU Lille, Service des Maladies du Sang, Lilles, France
(3)Levine Cancer Institute-Atrium Health, Charlotte, NC
(4)Vejle Hospital and University of Southern Denmark, Vejle, Denmark
(5)Department of Lymphoma/Myeloma, The University of Texas MD Anderson Cancer Center, Houston,
TX
(6)Hematology, University Hospital Hôtel-Dieu, Nantes, France
(7)Royal Wolverhampton Hospitals NHS Trust and University, Wolverhampton, United Kingdom
(8)Arnie Charbonneau Cancer Research Institute, University of Calgary, Calgary, AB, Canada
(9)University Clinic Heidelberg, Internal Medicine V and National Center for Tumor Diseases (NCT),
Heidelberg, Germany
(10)Department of Medicine/Haematology, NUI, Galway, Ireland
(11)Cross Cancer Institute, University of Alberta, Edmonton, Canada
(12)Department of Oncology, Hematology and Bone Marrow Transplantation with Section of
Pneumology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
(13)Department of Hematology, Hôpital Haut Lévêque, University Hospital, Pessac, France
(14)Department of Hematology, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon, Pierre-Bénite,
France
(15)Carmel MC, Haifa, Israel
(16)Erasmus MC Cancer Institute, Rotterdam, Netherlands
(17)Western Health, Sunshine Hospital, Cancer Services; St Albans, Victoria, Australia
(18)Department of Hematology, Skåne University Hospital, Lund, Sweden
(19)Janssen Research & Development, LLC, Spring House, PA
(20)Janssen Research & Development, LLC, Raritan, NJ
(21)Janssen Research & Development, Beerse, Belgium
(22)Janssen Global Medical Affairs, Horsham, PA
(23)Department of Hematology, Mayo Clinic Rochester, Rochester, MN
Objectives: Daratumumab, a human CD38-targeting IgG1κ monoclonal antibody, is approved as
monotherapy in relapsed/refractory multiple myeloma (RRMM) and in combination with standard-of-care
(SOC) regimens for RRMM and NDMM. Daratumumab plus SOC combinations have shown
improved progression-free survival (PFS), deep and durable responses, and higher rates of minimal
residual disease (MRD) negativity vs SOC. Treatment with D-Rd vs Rd in phase 3 MAIA (median follow
up, 28.0 months) showed significantly improved PFS and MRD-negative rates in transplant-ineligible
NDMM. With longer follow up (36.4 months), D-Rd maintained the PFS benefit and deeper and more
durable responses. The updated efficacy and safety findings from MAIA are presented.
Methods: Patients with NDMM ineligible for high-dose chemotherapy and autologous stem cell
transplantation due to age ≥65 years or comorbidities, were randomly assigned (1:1) to receive D-Rd
or Rd. Stratification factors: International Staging System (ISS) stage (I, II, III), region (North America,