Janssen: Phase 3 Study Shows Survival Benefits with DARZALEX® in Multiple Myeloma

 After nearly five years of follow-up, median progression-free survival was not reached, and a significant overall survival benefit was observed; dat presented as a late-breaking abstract at the European Hematology Association (EHA) Virtual Congress

The Janssen Pharmaceutical Companies of Johnson & Johnson announced overall survival (OS) results from the Phase 3 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.¹ 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 (Abstract #LB1901).

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.¹ 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].¹ 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].¹ These data are expected to form the basis of future regulatory submissions.

https://www.biospace.com/article/releases/janssen-announces-results-from-phase-3-maia-study-showing-significant-overall-survival-benefits-for-treatment-with-darzalex-daratumumab-in-patients-with-newly-diagnosed-multiple-myeloma-who-are-transplant-ineligible/