Multiple myeloma: daratumumab combination significantly improves OS in transplant-ineligible patients

  • Mateos M-V, et al.
  • Lancet Oncol.
  • 10 Dec 2019

  • curated by David Reilly
  • Univadis Clinical Summaries
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Takeaway

  • In patients with transplant-ineligible, newly diagnosed multiple myeloma (NDMM), the addition of daratumumab to bortezomib, melphalan, and prednisone (D-VMP) significantly reduced risk for death vs VMP alone.

Why this matters

  • This is the first daratumumab-based combination to demonstrate a significant improvement in survival in MM.

Study design

  • Updated results from the phase 3 ALCYONE trial of D-VMP (n=350) vs VMP alone (n=356) in 706 patients with transplant-ineligible NDMM.
  • Funding: Janssen Research & Development.

Key results

  • At 40.1 (Interquartile range [IQR], 37.4-43.1) months median follow-up:
    • 24% mortality with D-VMP vs 35% with VMP.
      • HR for death, 0.60 (95% CI, 0.46-0.80; P=.0003).
    • 50% disease progression or death with D-VMP vs 74% with VMP.
      • HR for PFS, 0.42 (95% CI, 0.34-0.51; P<.0001>
    • 90.9% (95% CI, 87.3%-93.7%) overall response with D-VMP vs 73.9% (95% CI, 69.0%-78.4%) with VMP.
      • OR, 3.55 (95% CI, 2.30-5.49; P<.0001>
    • 28% were minimal residual disease-negative (MRD−) with D-VMP vs 7% with VMP.
      • OR, 5.23 (95% CI, 3.27-8.36; P<.0001>
  • No new safety signals for D-VMP.

Limitations

  • After 9 cycles of VMP, patients in the D-VMP group continued to receive daratumumab.