Submission supported by data from the Phase 3 CEPHEUS study for the treatment of patients with newly diagnosed multiple myeloma for whom transplant is not planned as initial therapy1
Data showed that the daratumumab subcutaneous formulation-based quadruplet regimen significantly improved minimal residual disease (MRD)-negativity and reduced the risk of progression or death compared to standard of care regimen1
BEERSE, BELGIUM , Oct. 10, 2024 (GLOBE NEWSWIRE) — Janssen-Cilag International NV, a Johnson & Johnson company, today announced the submission of a Type II variation application to the European Medicines Agency (EMA) seeking approval for an indication extension of DARZALEX® (daratumumab) subcutaneous (SC) formulation in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd) for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM).2
“While we’ve seen significant progress in multiple myeloma treatment, there continues to be a tremendous opportunity to improve frontline therapies and ensure we are providing patients with better long-term outcomes,” said Edmond Chan, MBChB, M.D. (Res), EMEA Therapeutic Area Lead Hematology, Innovative Medicine, Johnson & Johnson. “The potential of this daratumumab subcutaneous-based regimen to transform outcomes for people with newly diagnosed multiple myeloma is incredibly promising, and today’s submission builds on our portfolio of Phase 3 studies aimed at elevating the standard of care for all patients in the frontline treatment setting.”
This submission is supported by data from the Phase 3 CEPHEUS study, which showed 60.9 percent of patients achieved minimal residual disease (MRD)-negativity with D-VRd and the risk of progression or death was reduced by 43 percent.1 The CEPHEUS study (NCT03652064), evaluated the efficacy and safety of D-VRd compared to VRd for NDMM patients who are transplant ineligible or for whom ASCT was not planned as initial therapy (transplant ineligible or deferred).1,3
The D-VRd regimen increased depth and durability of responses compared to VRd, including the primary endpoint of overall MRD-negativity rate (10-5) of 60.9 percent vs 39.4 percent at a median follow-up of 58.7 months (Odds Ratio [OR], 2.37; 95 percent confidence interval [CI], 1.58-3.55; p
