The final day of ASH gave us an important late-breaking abstract on Darzalex Faspro (daratumumab and hyaluronidase-fihj) in combination with the standard care regimen of Velcade (bortezomib), Revlimid (lenalidomide), and dexamethasone (VRd) in newly diagnosed patients with multiple myeloma (NDMM) who were eligible for an autologous stem cell transplant (ASCT).
Dr. Pieter Sonneveld and colleagues from the Netherlands presented findings from the phase 3 PERSEUS trial that showed the that subcutaneous Darzalex Faspro-based induction, consolidation and maintenance regimen reduced risk of progression or death by 58 percent compared to RVD (Abstract LBA-1).
Results of the trial, which included 709 patients with NDMM who were eligible for ASCT, were simultaneously published in the New England Journal of Medicine (Sonneveld P, NEJM 2023). The researchers reported that the 4-year PFS was 84% with D-VRd compared with 68% with VRd. Significantly more patients achieved higher minimum residual disease (MRD)-negative rates with the addition of Darzalex Faspro (75%) compared to VRd (48%). The overall safety profile of D-VRd was similar to previously reported (Voorhees PM, Lancet Haematol 2023) side effects with D-VRd. The most common (>10 percent) serious grade side effects with D-VRd vs VRd were low white blood cell counts (62% vs 51%), low platelet counts (29% vs 17%), diarrhea (11% vs 8%), and pneumonia (11% vs 6%).
The authors conclude that these results support Darzalex-based quadruplet induction and consolidation regimen and doublet maintenance regimen as a potential new standard of care for transplant-eligible patients with NDMM.
