Phase III MAIA (MMY3008) study of Darzalex + Revlimid in multiple myeloma published in the NEJM.
The Janssen Pharmaceutical Companies of Johnson & Johnson announced the publication of data from the randomized, open-label Phase III MAIA (MMY3008) study that showed Darzalex (daratumumab) plus Revlimid (lenalidomide) and dexamethasone (Rd) resulted in a significant increase in progression-free survival (PFS) in patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation (ASCT). Results from the MAIA study demonstrated that at a median follow-up of 28 months, Darzalex in combination with Rd, reduced the risk of disease progression or death by 44 percent in patients with newly diagnosed multiple myeloma who are ineligible for ASCT, compared to treatment with Rd alone (Hazard Ratio [HR] = 0.56; 95 percent confidence interval [CI]: 0.43-0.73; p<0.001). The median PFS for Darzalex-Rd has not yet been reached, compared to 31.9 months for patients who received Rd alone. The overall response rate (ORR) was 92.9 percent in the Darzalex-Rd arm versus 81.3 percent in the Rd arm (p<0.001). The addition of Darzalex resulted in near-doubling of complete response (CR) or better (47.6 percent vs. 24.9 percent). In the MAIA study, treatment with DARZALEX-Rd resulted in a greater than threefold rate of minimal residual disease (MRD) negativity compared to Rd alone (24.2 percent vs. 7.3 percent). All patients with MRD-negative status also had a response of CR or better. Patients who achieved MRD negativity demonstrated longer PFS than patients who remained MRD-positive, regardless of study treatment. The safety of Darzalex in combination with Rd in this patient population was consistent with previously reported studies. These data were published in The New England Journal of Medicine.
See: "Daratumumab Plus Lenalidomide and Dexamethasone for Untreated Myeloma." Facon, T, et al. The New England Journal of Medicine. Accessed May 2019. https://www.nejm.org/doi/full/10.1056/NEJMoa1817249?query=featured_home.
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