Efficacy Demonstrated with DARZALEX® + VTd

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DARZALEX® + bortezomib + Thalomid® (thalidomide) + dexamethasone

Adding DARZALEX® (daratumumab) to VTd resulted in significantly more patients with sCR vs VTd alone after consolidation1,2

sCR was assessed in the ITT population.

Primary endpoint: sCR assessed 100 days after transplant, or immediately following consolidation if greater than 100 days.

DARZALEX® + VTd post-consolidation responses1,2

CR=complete response; HR=hazard ratio; ITT=intent-to-treat; MM=multiple myeloma; OR=odds ratio; ORR=overall response rate; PR=partial response; sCR=stringent complete response; VGPR=very good partial response; VTd=bortezomib (V) + thalidomide (T) + dexamethasone (d).

53% reduction in the risk of disease progression or death with DARZALEX® + VTd vs VTd alone1,2*

*Based on interim analysis and the boundary for PFS was crossed.

~90% of patients in each treatment arm underwent ASCT2,3

  • 489 (90%) with DARZALEX® + VTd and 484 (89%) with VTd alone
  • 100% of patients who received a transplant achieved hematopoietic reconstitution
  • 85% of patients in the DARZALEX® + VTd group and 81% of those in the VTd group completed all 4 induction and both consolidation cycles at 18.8 months (median follow-up)

ASCT=autologous stem cell transplant; HR=hazard ratio; ITT=intent-to-treat; MM=multiple myeloma; PFS=progression-free survival; sCR=stringent complete response; VTd=bortezomib (V) + thalidomide (T) + dexamethasone (d).

­­† In the ITT analysis, patients who did not receive ASCT were considered nonresponders for post-transplant analyses.
Neutrophils >0.5 × 109/L, leukocytes >1.0 × 109/L, and platelets >50 × 109/L (without transfusion).

DARZALEX® (daratumumab) + VTd consistently improved depth of response

Responses assessed 100 days after transplant, or immediately following consolidation if greater than 100 days1,3

93% ORR for DARZALEX® + VTd includes patients in the ITT population:

  • With a PR or better at the prespecified time point

Response rates over time3,4

  • Post-induction, post-ASCT, and best response analyses were not adjusted for multiplicity.
    This information is not included in the Prescribing Information
  • Median duration of follow-up was 18.8 months (0.0–32.2)

Best response of stringent complete response (sCR), complete response (CR), sCR + CR, very good partial response (VGPR), VGPR or better (sCR + CR + VGPR), partial response (PR), overall response (sCR + CR + VGPR + PR), stable disease (SD), progressive disease (PD), and not evaluable (NE) were derived based on the computerized algorithm, according to IMWG response criteria, during the study treatment period.

ASCT=autologous stem cell transplant; IMWG=International Myeloma Working Group; ITT=intent-to-treat; ORR=overall response rate; VTd=bortezomib (V) + thalidomide (T) + dexamethasone (d).