FDA approves daratumumab combo for newly diagnosed multiple myeloma


  • David Reilly
  • Oncology drug update
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Takeaway

  • The FDA has approved daratumumab in combination with lenalidomide and dexamethasone (DRd) for patients with newly diagnosed multiple myeloma (NDMM) ineligible for autologous stem cell transplant (ASCT).

Why this matters

  • Many older patients with MM are ineligible for ASCT.

Study design

  • Approval was based on the MAIA phase 3 study of DRd vs lenalidomide+low-dose dexamethasone (Rd) in 737 patients with NDMM ineligible for ASCT.
  • 44% of patients were aged ≥75 years.
  • Funding: Janssen Biotech, Inc.

Key results

  • 92.9% overall response with DRd vs 81.3% with Rd (P<.0001>
  • Median PFS was not reached with DRd vs 31.9 months with Rd: HR, 0.56; 95% CI, 0.43-0.73; P<.0001.>
  • 47.6% complete response or better with DRd vs 24.9% with Rd (P<.0001>
  • 24.2% (95% CI, 19.9%-28.9%) achieved minimal residual disease (MRD) negativity with DRd vs 7.3% (95% CI, 4.9%-10.5%) with Rd (P<.0001>
  • Median time to response with DRd, 1.05 (range, 0.2-12.1) months vs 1.05 (range, 0.3-15.3) months with Rd.
  • Median duration of response was not reached with DRd vs 34.7 months (95% CI, 30.8-not estimable) with Rd.
  • Most common adverse reactions (≥20%) included infusion reactions, diarrhea, constipation.

Limitations

  • Open-label study.

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