- 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.
- 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.
- 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.
- Interim analysis.