DARZALEX® + VMP Demonstrated Proven Efficacy vs VMP Alone

Share

DARZALEX® + Velcade® (bortezomib) + melphalan + prednisone

DARZALEX® + VMP significantly improved PFS vs VMP alone (P<0.0001)1

 

PFS=progression-free survival; HR=hazard ratio.

 

Significant improvement in ORRs with DARZALEX® + VMP1

Almost all patients (91%) treated with DARZALEX® + VMP achieved an ORR1

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

 

91%overall response ratewith DARZALEX® + VMP

vs

74%overall response ratewith + VMP alone (P<0.0001)

 

Speed of response

In responders, median time to response was 0.79 months (range: 0.4 to 15.5 months) in the DARZALEX® + VMP group and 0.82 months (range: 0.7 to 12.6 months) in the VMP group1,2

  • Median time to VGPR or better was 2.2 months (range: 0.7, 19.2)
  • Median time to CR or better was 8.3 months (range: 1.9, 21.0)

Depth of response

42.6% of patients achieved CR or better with DARZALEX® + VMP vs 24.4% with VMP alone1

Duration of response

Median duration of response had not yet been reached with DARZALEX® + VMP vs 21.3 months (range: 0.5+, 23.7+) with VMP alone1

 

Significantly higher MRD negativity rate with DARZALEX® + VMP1*

3.6x higher MRD negativity rate with DARZALEX® + VMP vs VMP alone (P<0.0001)1

  • MRD based on threshold of 10-5 using a next-generation sequencing assay1,3*
  • In patients with CR or better, the MRD negativity rate was 49.7% (n=74)(95% CI: 41.4, 58.0) in the DARZALEX® + VMP arm vs 25.3% (n=22)(95% CI: 16.6, 35.7) with VMP arm1

MRD=minimal residual disease.

*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 complete response or stringent complete response, and thereafter at 12, 18, 24, and 30 months.1-3

Daratumumab (DARZALEX®) in combination with bortezomib, melphalan, and prednisone is recommended by the NCCN Clinical Practice Guidelines In Oncology (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.1.2019. © National Comprehensive Cancer Network, Inc. 2018. Accessed July 25, 2018. 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.