The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of subcutaneous daratumumab plus VRd for patients with newly diagnosed, transplant-eligible multiple myeloma. This recommendation is based on positive findings from the phase 3 PERSEUS study, which showed significant improvements in progression-free survival (PFS) rates with the daratumumab-containing regimen compared to VRd alone.
The study demonstrated deep and durable minimal residual disease (MRD) negativity in patients treated with D-VRd, highlighting the effectiveness of this quadruplet regimen. The percentage of patients achieving MRD-negative status was significantly higher in the D-VRd arm compared to VRd, indicating the superior efficacy of the combination therapy.
Furthermore, updated data presented at the 2024 ASCO Annual Meeting showed continued deepening responses with D-VRd over time, with higher rates of complete response (CR) or better and deeper MRD negativity observed in the daratumumab-containing arm. These results suggest that the addition of daratumumab to the treatment regimen can lead to improved outcomes for patients with newly diagnosed multiple myeloma.
Edmond Chan, EMEA Therapeutic Area Lead Haematology at Johnson & Johnson Innovative Medicine, emphasized the importance of optimizing frontline therapy to control the disease and enhance long-term outcomes for patients. By incorporating subcutaneous daratumumab into the quadruplet regimen, the goal is to establish a new standard of care for eligible patients, ultimately transforming the treatment landscape for multiple myeloma.
The PERSEUS trial design, treatment, and objectives were tailored to evaluate the efficacy of D-VRd in comparison to VRd alone in newly diagnosed multiple myeloma patients eligible for high-dose therapy and ASCT. The results demonstrated the potential of the daratumumab-containing regimen to improve PFS and key secondary endpoints such as overall CR or better rate, overall MRD negativity rate, and overall survival.
Additionally, the study investigated MRD negativity in patients with high-risk disease and found that D-VRd was associated with higher rates of sustained MRD negativity compared to VRd. Patients in the D-VRd arm showed improved PFS outcomes, even in those with MRD-negative, high-risk disease, highlighting the benefits of incorporating daratumumab into the treatment plan.
During the maintenance phase, a higher proportion of patients in the D-VRd arm achieved MRD-negative status compared to the VRd arm, underscoring the importance of sustained MRD negativity in improving long-term outcomes for patients with multiple myeloma. These findings support the potential of the daratumumab-based quadruplet regimen to enhance disease control and progression-free survival for newly diagnosed, transplant-eligible patients.
In conclusion, the positive opinion from the EMA’s CHMP regarding the approval of subcutaneous daratumumab plus VRd represents a significant advancement in the treatment of multiple myeloma. The promising results from the PERSEUS study and subsequent data presentations highlight the potential of this novel quadruplet regimen to improve outcomes and establish a new standard of care for patients with newly diagnosed multiple myeloma.