Phase III MAIA study of Darzalex + Revlimid + dexamethasone shows survival benefits in multiple myeloma – Janssen Biotech

The Janssen Pharmaceutical Companies of Johnson & Johnson announced overall survival (OS) results from the Phase III MAIA (NCT02252172) study showing the addition of Darzalex (daratumumab) to lenalidomide and dexamethasone (D-Rd) resulted in a statistically significant survival benefit over lenalidomide and dexamethasone (Rd) alone in patients with newly diagnosed multiple myeloma (NDMM) who were ineligible for autologous stem cell transplant (ASCT) and were treated to progression. The prespecified interim analysis for OS found that after a median follow-up of nearly five years (56.2 months), a 32 percent reduction in the risk of death was observed in the D-Rd treatment arm vs. Rd arm.

Median OS was not reached in either arm [hazard ratio (HR): 0.68, 95 percent confidence interval (CI), 0.53-0.86; p=0.0013]. Median progression-free survival (PFS) was not reached after nearly five years and the PFS benefit observed with D-Rd was maintained, with a 47 percent reduction in risk of disease progression or death [HR: 0.53; 95 percent CI, 0.43-0.66; p<0.0001]. The estimated five-year OS rate of 66 percent with D-Rd vs. 53 percent with Rd [HR: 0.68; 95 percent CI, 0.53-0.86; p=0.0013]. The estimated five-year PFS rate of 53 percent with D-Rd vs. 29 percent with Rd [HR: 0.53; 95 percent CI, 0.43-0.66; p<0.0001].

Median time to next treatment was not reached with D-Rd vs. 42.4 months with Rd [HR: 0.47; 95 percent CI, 0.37-0.59; p<0.0001]. Updated overall response rate (ORR) of 93 percent with D-Rd vs. 82 percent with Rd. No new safety concerns were identified in the D-Rd arm.These data are expected to form the basis of future regulatory submissions. These data were featured in the European Hematology Association (EHA) 2021 Virtual Press Briefing and will be presented as a late-breaking abstract during the EHA Virtual Congress.