DARZALEX® + Rd Demonstrated Superior Efficacy vs Rd Alone in Adult Patients With Newly Diagnosed, Transplant-Ineligible MM1

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The MAIA trial regimen was DARZALEX® + Rd vs Rd alone

DARZALEX® + Revlimid® (lenalidomide) + dexamethasone

Median PFS still not reached with DARZALEX® + Rd after 28 months of follow-up* vs 31.9 months for Rd alone1,2

Progression-free survival (PFS)

DARZALEX® + Rd significantly improved PFS vs Rd alone in newly diagnosed, transplant-ineligible MM: median PFS not reached after 28 months of follow-up vs 31.9 months for Rd alone (P<0.0001)

*Range: 0.0–41.4.

Kaplan-Meier estimate.

DRd=DARZALEX® (D) + lenalidomide (R) + dexamethasone (d); HR=hazard ratio; MM=multiple myeloma; Rd=lenalidomide (R) + dexamethasone (d).

Revlimid® is a registered trademark of Celgene Corporation.

 

DARZALEX® + Rd demonstrated deep and durable responses in newly diagnosed, transplant-ineligible MM1

93% ORR was achieved with DARZALEX® + Rd1

Overall response rates (ORRs)

DARZALEX® + Rd significantly improved ORR vs Rd alone in newly diagnosed, transplant-ineligible MM: 93% vs 81%

CR=complete response; PR=partial response; sCR=stringent complete response; VGPR=very good partial response.

Depth of response with DARZALEX® + Rd

DRd nearly doubled the number of patients who achieved CR or better vs Rd alone1

  • More than doubled sCR§: 30% with DRd vs 13% with Rd alone

Durability of response with DARZALEX® + Rd

Median duration of response has not yet been reached with DRd vs 34.7 months (95% CI: 30.8, not estimable) for Rd alone1

Speed of response with DARZALEX® + Rd

Median time to response was 1.05 months with DRd (range: 0.2 to 12.1 months) and with Rd alone (range: 0.3 to 15.3 months)1

§sCR is CR plus the attainment of normal free light-chain ratio and the absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.2

 

MRD negativity rates more than tripled with DARZALEX® + Rd1

3.4x greater MRD negativity with DRd

DARZALEX® + Rd significantly improved MRD negative rates in newly diagnosed, transplant-ineligible MM vs Rd alone: 24% vs 7%

MRD=minimal residual disease.

Superior MRD rates vs Rd alone

  • 24% of patients were MRD negative with DRd (95% CI: 19.9%, 28.9%)1
  • 7% of patients were MRD negative with Rd (95% CI: 4.9%, 10.5%)1

MRD was based on a sensitivity threshold of 10-5 using a next-generation sequencing assay (clonoSEQ®).1,2

MRD negativity was defined as undetectable levels of multiple myeloma cells by bone marrow aspirate at any time point after the randomization and before disease progression or start of subsequent therapy and in the trial was assessed by means of next-generation sequencing assay at a sensitivity threshold of 10-5 via bone marrow aspirate, collected at initial trial screening, at the time of confirmation of CR or sCR, and thereafter at 12, 18, 24, and 30 months.2,3

clonoSEQ® is a registered trademark of Adaptive Biotechnologies.

Daratumumab (DARZALEX®) in combination with lenalidomide and dexamethasone is recommended by the NCCN® Guidelines as a preferred Category 1 therapeutic option for non-transplant candidates#

Category 1=based upon high-level evidence, there is uniform National Comprehensive Cancer Network® (NCCN®) consensus that the intervention is appropriate.

#Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Multiple Myeloma V.1.2020. © National Comprehensive Cancer Network, Inc. 2019. Accessed September 11, 2019. All rights reserved. To view the most recent and complete version of the guideline, go online to www.nccn.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.