The trial assessed Darzalex SC formulation-based quadruplet induction, consolidation regimen and doublet maintenance regimen in patients with transplant-eligible (TE) newly diagnosed multiple myeloma
Janssen’s Darzalex SC quadruplet therapy shows positive results in phase 3 trial. (Credit: Alessandro Giordano from Pixabay)
The Janssen Pharmaceutical Companies of Johnson & Johnson said that the Darzalex (daratumumab) subcutaneous (SC) formulation-based quadruplet therapy regimen has shown improved outcomes in the Phase 3 PERSEUS trial of certain patients with multiple myeloma.
The trial assessed Darzalex SC formulation-based quadruplet induction, consolidation regimen and doublet maintenance regimen in patients with transplant-eligible (TE) newly diagnosed multiple myeloma (NDMM).
PERSEUS is designed to assess the safety and efficacy of daratumumab SC in combination with bortezomib, lenalidomide and dexamethasone (D-VRd) followed by daratumumab SC and lenalidomide (D-R) maintenance versus VRd followed by R maintenance.
The data showed clinically significant improvement in progression-free survival (PFS), rates of overall complete response (CR) or better and minimal residual disease (MRD) negativity over the comparator arm.
Daratumumab SC in combination with consolidation and maintenance regimen lowered the risk of progression or death by 58% compared to VRd alone followed by R maintenance.
The quadruplet regimen also significantly boosted the depth of response in comparison to treatment with VRd alone.
In addition, the overall safety profile of D-VRd was similar to the already known safety profiles for daratumumab SC and VRd.
Johnson & Johnson innovative medicine late development and global medical affairs VP Craig Tendler said: “We now have evidence supporting this daratumumab subcutaneous-based quadruplet induction and consolidation regimen and doublet maintenance regimen as a potential standard of care in transplant-eligible disease, complementing data from the Phase 3 MAIA study, which established a daratumumab-based triplet therapy as standard of care in transplant-ineligible disease.
“We will continue to advance innovative regimens and approaches with daratumumab to deliver on our commitment to transforming outcomes for patients with multiple myeloma.”
PERSEUS is an ongoing, randomised, open-label, late-stage trial conducted in partnership with the European Myeloma Network.
Its primary endpoint was PFS, and secondary endpoints consisted of overall CR or better rate, overall MRD-negativity and overall survival.