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)
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.
At 30 months: 70.6% of patients had not progressed with DRd vs 55.6% of patients in the Rd group (DRd: 95% CI, 65.0–75.4; Rd: 95% CI, 49.5–61.3).2
DARZALEX® + Rd demonstrated deep and durable responses in newly diagnosed, transplant-ineligible MM1
93% ORR was achieved with DARZALEX® + Rd1‡
Overall response rates (ORRs)
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
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.