ASH 2018 — Add-on daratumumab boosts PFS in transplant-ineligible MM


  • Univadis
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Takeaway

  • Adding daratumumab (D) to lenalidomide+dexamethasone (Rd) extends PFS by 44% in patients with transplant-ineligible multiple myeloma (MM).

Why this matters

  • Results support D-Rd as the new standard of care in this patient population.

Study design

  • Multinational phase 3 MAIA study comparing D-Rd with Rd in 737 transplant-ineligible patients with newly diagnosed MM, treated until progression or unacceptable toxicity.
  • Median patient age, 73 years (≥75 years, 44%).
  • Interim analysis with median follow-up of 28 months.
  • Funding: Janssen.

Key results

  • 44% reduction in risk for progression or death in patients assigned D-Rd (HR, 0.56; P<.0001>
  • Median PFS not reached in the D-Rd group vs 31.9 months in the Rd group.
  • Overall response rate, 93% in the D-Rd group vs 81% in the Rd-alone group (P<.0001>
  • Rate of complete response (CR)+stringent CR, 47.6% with D-Rd vs 24.7% with Rd (OR, 2.75; P<.0001> 
  • Very good partial response or better rate, 79.3% with D-Rd vs 53.1% with Rd (OR, 3.4; P.0001).
  • Rates of minimum residual disease negativity by next-generation sequencing (10−5 sensitivity threshold), 24% with D-Rd vs 7% with Rd (P<.0001>
  • 19% of patients have died (HR for OS, 0.78; 95% CI, 0.56-1.1) with ongoing follow-up.
  • Higher rates of grade 3/4 pneumonia (14% vs 8%) and neutropenia (50% vs 35%) in the D-Rd group.

Limitations

  • Interim analysis.

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