Dr Sonneveld on the FDA Approval of Subcutaneous Daratumumab Plus VRd in Myeloma

Pieter Sonneveld, MD, PhD, professor, hematology, Erasmus University of Rotterdam, Erasmus Medical Center; chairman, HOVON Multiple Myeloma Working Group, European Myeloma Network, discusses the FDA approval of daratumumab and hyaluronidase-fihj (Darzalex Faspro) in combination with bortezomib (Velcade), lenalidomide (Revlimid), and dexamethasone (Darzalex Faspro-VRd; D-VRd) for induction and consolidation in patients with newly diagnosed multiple myeloma who are also candidates for autologous stem cell transplant.

On July 30, 2024, the regulatory agency granted approval to the combination based on data from the phase 3 PERSEUS trial (NCT03710603). In the investigation, patients treated with D-VRd (n = 355) had a significantly improved progression-free survival (PFS) vs VRd alone (n = 354; HR, 0.40; 95% CI, 0.29-0.57; P < .0001). Furthermore, the median PFS was not yet reached in either treatment arm.

This regimen has generated a remarkably high response rate, with many patients achieving complete responses or better, Sonneveld begins. Additionally, the rate of minimal residual disease (MRD) negativity continues to increase as patients progress from initial treatment into the maintenance phase. Notably, the maintenance phase has been well tolerated, he explains. Patients have the option to discontinue daratumumab after 2 years, continuing with lenalidomide alone if they have achieved sustained MRD negativity, Sonneveld reports.

This combination of high efficacy and tolerability positions the regimen as an ideal candidate for standard-of-care treatment, he continues, and it has already become the standard in several European countries. The hope is that other countries in Europe will soon adopt this regimen as well, replacing older treatments that do not include daratumumab, Sonneveld advocates. The introduction of this regimen represents animprovement in both prognosis and quality of life for patients with newly diagnosed multiple myeloma, offering benefits for the future, according to Sonneveld.

Although it’s too early to determine the long-term overall survival rates, the current evidence strongly supports this regimen as a superior choice for standard care worldwide, he states. Further improvements may arise, but for now, this approach is a major step forward, Sonneveld concludes.