DARZALEX FASPRO Quadruplet Regimen Demonstrates Striking Advancements in Treatment Outcomes for Newly Diagnosed Multiple Myeloma Eligible for Transplantation

The PERSEUS study is being conducted in collaboration with the European Myeloma Network as a sponsor. PERSEUS is an ongoing, randomized, open-label, Phase III study comparing the efficacy and safety of D-VRd followed by D-R maintenance vs VRd followed by R maintenance in patients with transplant-eligible NDMM. The findings presented at the ASH 2023 demonstrated that, at a median follow-up of 47.5 months, the 4-year progression-free survival (PFS) rate with D-VRd was 84.3% vs. 67.7% with VRd, resulting in a 58% reduction in the risk of disease progression or death with the addition of the CD38 monoclonal antibody. Moreover, the comprehensive response rate, including complete response or better (≥CR), was 87.9% for D-VRd compared to 70.1% for VRd (P <.0001). In the D-VRd group, the rates of stringent complete response (sCR) and complete response (CR) were 69.3% and 18.6%, respectively, while in the VRd group, these rates were 44.6% and 25.4%. Furthermore, the quadruplet regimen substantially enhanced the extent of response in contrast to VRd monotherapy, resulting in elevated rates of complete response or better, stringent complete response (sCR), and minimal residual disease (MRD) negativity.

The overall safety profile of D-VRd remained consistent with the established safety profiles of daratumumab and VRd. The most frequently occurring Grade 3/4 hematologic and non-hematologic adverse events (AE) with D-VRd, in comparison to VRd, included neutropenia (62.1% vs. 51.0%), thrombocytopenia (29.1% vs. 17.3%), diarrhea (10.5% vs. 7.8%), pneumonia (10.5% vs. 6.1%), and febrile neutropenia (9.4% vs. 10.1%).

Below is the expected launch year for D-RVd in both the frontline setting for patients eligible for transplantation and patients not eligible for transplantation.

KOL Insights

“These randomized, phase 3 results support D-VRd followed by DR maintenance as a new standard of care [SOC] for transplant-eligible patients with newly diagnosed multiple myeloma. [Additionally], 64% of patients receiving maintenance in the D-VRd group were able to discontinue daratumumab after achieving sustained MRD negativity per protocol.” –Expert Opinion.

Conclusion

The findings from this randomized Phase III trial endorse D-VRd induction followed by DR maintenance as the emerging standard of care for individuals eligible for transplantation with newly diagnosed multiple myeloma.

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