Daratumumab/lenalidomide/dexamethasone in transplant-ineligible newly diagnosed myeloma: MAIA long-term outcomes

In the MAIA study, daratumumab plus lenalidomide and dexamethasone (D-Rd) improved progression-free survival (PFS) and overall survival (OS) versus lenalidomide and dexamethasone (Rd) alone in transplant-ineligible patients with newly diagnosed multiple myeloma (NDMM). We report updated efficacy and safety from MAIA (median follow-up, 64.5 months), including a subgroup analysis by patient age (<70, ≥70 to <75, ≥75, and ≥80 years). Overall, 737 transplant-ineligible patients with NDMM were randomized 1:1 to D-Rd or Rd. The primary endpoint, PFS, was improved with D-Rd versus Rd (median, 61.9 vs 34.4 months; hazard ratio [HR], 0.55; 95% confidence interval [CI], 0.45-0.67; P < 0.0001). Median OS was not reached in the D-Rd group versus 65.5 months in the Rd group (HR, 0.66; 95% CI, 0.53-0.83; P = 0.0003); estimated 60-month OS rates were 66.6% and 53.6%, respectively. D-Rd achieved higher rates of complete response or better (≥CR; 51.1% vs 30.1%), minimal residual disease (MRD) negativity (32.1% vs 11.1%), and sustained MRD negativity (≥18 months: 16.8% vs 3.3%) versus Rd (all P < 0.0001). D-Rd demonstrated clinically meaningful efficacy benefits across age groups. No new safety concerns were observed. Updated results (median follow-up, >5 years) continue to support frontline use of D-Rd in transplant-ineligible patients with NDMM.

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Publication Details

Journal
Leukemia
Published
2025-02-27
DOI
https://doi.org/10.1038/s41375-024-02505-2
Citations
32
Primary Topic
Multiple Myeloma Research and Treatments
Type
article
Field-Weighted Citation Impact
56.64

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article

Daratumumab/lenalidomide/dexamethasone in transplant-ineligible newly diagnosed myeloma: MAIA long-term outcomes

Christopher P. Venner, Ajai Chari, Saad Z. Usmani, Michael E O'Dwyer et al.
32 citations
Leukemia
Multiple Myeloma Research and Treatments
56.64
article

Daratumumab/lenalidomide/dexamethasone in transplant-ineligible newly diagnosed myeloma: MAIA long-term outcomes

Christopher P. Venner, Ajai Chari, Saad Z. Usmani, Michael E O'Dwyer, Katja Christina Weisel, Thierry T.F. Facon, Shaji Kunnathu Kumar, Torben Plesner, Robert Zygmunt Orlowski, Gordon C Cook, Huiling Pei, Caroline Jacquet, Xavier P Leleu, Fredrik Borgsten, Noopur S Raje, Hartmut Goldschmidt, Richard G. Carson, Nizar Jacques Bahlis, Margaret Macro, Aurore Perrot, Maria Krevvata, Supratik Basu, Cyrille Hulin, George Wang, Hang Quach, Laurent Frenzel, Philippe Moreau, Mourad Tiab
article en
32 citations

Abstract

In the MAIA study, daratumumab plus lenalidomide and dexamethasone (D-Rd) improved progression-free survival (PFS) and overall survival (OS) versus lenalidomide and dexamethasone (Rd) alone in transplant-ineligible patients with newly diagnosed multiple myeloma (NDMM). We report updated efficacy and safety from MAIA (median follow-up, 64.5 months), including a subgroup analysis by patient age (<70, ≥70 to <75, ≥75, and ≥80 years). Overall, 737 transplant-ineligible patients with NDMM were randomized 1:1 to D-Rd or Rd. The primary endpoint, PFS, was improved with D-Rd versus Rd (median, 61.9 vs 34.4 months; hazard ratio [HR], 0.55; 95% confidence interval [CI], 0.45-0.67; P < 0.0001). Median OS was not reached in the D-Rd group versus 65.5 months in the Rd group (HR, 0.66; 95% CI, 0.53-0.83; P = 0.0003); estimated 60-month OS rates were 66.6% and 53.6%, respectively. D-Rd achieved higher rates of complete response or better (≥CR; 51.1% vs 30.1%), minimal residual disease (MRD) negativity (32.1% vs 11.1%), and sustained MRD negativity (≥18 months: 16.8% vs 3.3%) versus Rd (all P < 0.0001). D-Rd demonstrated clinically meaningful efficacy benefits across age groups. No new safety concerns were observed. Updated results (median follow-up, >5 years) continue to support frontline use of D-Rd in transplant-ineligible patients with NDMM.

LeukemiaVol. 39(4)
University of Wolverhampton (GB), Hôpital Necker-Enfants Malades (FR), BC Cancer Agency (CA), University of Leeds (GB), Mayo Clinic (US), Memorial Sloan Kettering Cancer Center (US), The University of Texas MD Anderson Cancer Center (US), Université Toulouse III - Paul Sabatier (FR), University of Alberta (CA), Universität Hamburg (DE), The University of Melbourne (AU), University of Calgary (CA), University of Southern Denmark (DK), Université Fédérale de Toulouse Midi-Pyrénées (FR), Ollscoil na Gaillimhe – University of Galway (IE), Heidelberg University (DE), Université de Lille (FR), University Hospital Heidelberg (DE), WinnMed (US), Centre Hospitalier Universitaire de Lille (FR), Centre Hospitalier Universitaire de Toulouse (FR), St Vincent's Hospital Melbourne (AU), Massachusetts General Hospital (US), Institute of Cancer Research (CA), Vejle Sygehus (DK), Centre Hospitalier Régional et Universitaire de Nancy (FR), Roche (France) (FR), University Medical Center Hamburg-Eppendorf (DE), Centre Hospitalier Universitaire de Poitiers (FR), Centre Hospitalier Universitaire de Caen Normandie (FR), Hôpital Cardiologique du Haut-Lévêque (FR), Mayo Clinic in Arizona (US), Cancer Research UK Clinical Trials Unit (GB), Mayo Clinic in Florida (US), Centre Hospitalier Départemental Vendée (FR), Janssen (United States) (US), The Royal Wolverhampton NHS Trust (GB), Icahn School of Medicine at Mount Sinai (US)
Janssen Research and Development
Good health and well-being
Openalex Percentile: Top 0%
Multiple Myeloma Research and Treatments
56.64
DOIOpen Access PDFOpenAlex
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