FDA approves daratumumab for ASCT-eligible multiple myeloma


  • David Reilly
  • Oncology drug update
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Takeaway

  • On September 26, 2019, the FDA approved daratumumab in combination with bortezomib, thalidomide, and dexamethasone (DVTd) for the treatment of adult patients with newly diagnosed multiple myeloma (MM) eligible for autologous stem cell transplant (ASCT).

Why this matters

  • This is the sixth FDA-approved indication for daratumumab in the treatment of MM.

Study design

  • Approval was based on the results of the phase 3 CASSIOPEIA trial comparing induction and consolidation DVTd (n=543) vs VTd (542) in 1085 patients with newly diagnosed MM eligible for ASCT.
  • Median patient age: 58.0 (range, 22-65) years.
  • Funding: Janssen Biotech, Inc.

Key results

  • 18.8 months of median follow-up.
  • 92.6% overall response rate with DVTd vs 89.9% with VTd.
  • Median PFS was not reached in either treatment group.
    • 53% reduction in the rate of progression or death in patients treated with DVTd (HR, 0.47; 95% CI, 0.33-0.67; P<.0001>
  • 28.9% stringent complete response rate at 100 days post-ASCT with DVTd vs 20.3% with VTd (P=.0010).
  • No significant difference in the frequency or type of serious adverse events between treatment groups.

Limitations

  • Open-label study design.

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