New long-term progression free survival data projections reinforce subcutaneous DARZALEX® (daratumumab) quadruplet therapy as a foundational standard of care for patients with newly diagnosed multiple myeloma
Median progression free survival projected to be 17 years for transplant eligible patients receiving daratumumab-based regimen1
Beerse, Belgium (11 April 2025) - Janssen-Cilag International NV, a Johnson & Johnson company, today announced new data from an analysis modelling long-term progression free survival (PFS) in transplant eligible (TE) and transplant ineligible (TIE) newly diagnosed multiple myeloma (NDMM) patients treated with DARZALEX® (daratumumab)-subcutaneous (SC) therapy in combination with bortezomib, lenalidomide and dexamethasone (VRd).1 These data, which were presented at the 6th European Myeloma Network (EMN) meeting in Athens, Greece, reported that median PFS (mPFS) projections based on the PERSEUS and CEPHEUS trials were significantly longer with daratumumab-VRd regimens compared to VRd regimens.1
“Survival outcomes for people newly diagnosed with multiple myeloma may now extend beyond the duration that can be captured in a clinical trial, and modelling approaches are becoming even more common to help estimate these improvements,” said Pieter Sonneveld M.D., Ph.D, Head of the Department of Hematology, Erasmus University Medical Center. “The PFS projections presented indicate that people with newly diagnosed multiple myeloma who are eligible for transplant and treated with the PERSEUS regimen may live more than 17 years without their disease progressing. These data reinforce the critical role of transplant with daratumumab maintenance therapy to achieving the best possible outcomes for patients.”
The PERSEUS trial enrolled patients with TE NDMM who had a median age of 60 years and the CEPHEUS trial enrolled patients with TIE or TE NDMM who had a median age of 70 years.2,3 In PERSEUS, after a median follow-up of 47.5 months, daratumumab-VRd + daratumumab SC and lenalidomide (DR) maintenance led to a reduction in risk of progression or death by 58 percent versus VRd + lenalidomide (R).2 In CEPHEUS, after a median follow-up of 58.7 months, daratumumab-VRd resulted in a 43 percent reduction versus VRd.3 Based on these results, mPFS has not yet been reached in the daratumumab-VRd arm for either trial,2,3 supporting the use of long-term modelling to inform economic and clinical decision making. Modelling showed that in PERSEUS, the best-fit mPFS estimates were 17.1 years (13.2-21.2 years) for daratumumab-VRd + DR maintenance versus 7.3 years (6.3-9.9 years) for VRd + R maintenance.1,4 For the CEPHEUS TIE population, mPFS estimates were 8.3 years (8.0-9.8 years) for daratumumab-VRd versus 4.4 years (4.3-4.5 years) for VRd.1,4 Both models showed that the addition of daratumumab significantly extended mPFS.
“Improving long-term outcomes remains the key goal in treatment of multiple myeloma. At diagnosis, the median age of people with newly diagnosed multiple myeloma is about 65 years old,” said Edmond Chan, MBChB, M.D. (Res), EMEA Therapeutic Area Lead Haematology, Johnson & Johnson Innovative Medicine. “These PFS projections suggest that some patients receiving daratumumab-VRd could potentially remain progression free and offers them hope of living an average life expectancy. These data continue to build on the body of evidence for daratumumab SC, cementing it as a transformative, frontline therapy, regardless of transplant eligibility.”
