Primary Results of Phase 3 Perseus Trial: Daratumumab (DARA) + Bortezomib, Lenalidomide, and Dexamethasone (VRd) vs. Vrd Alone in Myeloma Patients Eligible for ASCT
Pieter Sonneveld, MD, PhD, discusses the results of the phase 3 Perseus Trial for myeloma patients eligible for autologous stem cell transplantation (ASCT).
Abstract title:
Phase 3 Randomized Study of Daratumumab (DARA) + Bortezomib, Lenalidomide, and Dexamethasone (VRd) Versus Vrd Alone in Patients (Pts) with Newly Diagnosed Multiple Myeloma (NDMM) Who Are Eligible for Autologous Stem Cell Transplantation (ASCT): Primary Results of the Perseus Trial
What is the purpose of this trial?
The PERSEUS study is a phase 3 clinical trial evaluating the effectiveness of subcutaneous Daratumumab (DARA SC) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) as induction/consolidation therapy, followed by Daratumumab and lenalidomide maintenance (D-R), compared to VRd induction/consolidation and lenalidomide maintenance in transplant-eligible patients with newly diagnosed multiple myeloma (NDMM). The study included 709 patients randomized into two groups, with a median age of 60 years. The primary endpoint was progression-free survival (PFS), and key secondary endpoints included overall complete response or better (≥CR) rate, overall minimal residual disease (MRD)–negativity rate, and overall survival.
In this video:
Pieter Sonneveld, MD, PhD (Erasmus MC Cancer Institute — Rotterdam, Netherlands) discusses the effectiveness of Daratumumab (DARA SC) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) as induction/consolidation therapy as opposed to VRd alone in myeloma patients eligible for autologous stem cell transplantation.
Conclusion:
Results from the study revealed that the DARA SC combined with VRd significantly improved PFS compared to VRd alone, with a hazard ratio of 0.42 and a 48-month estimated PFS rate of 84.3% for DARA SC plus VRd versus 67.7% for VRd. Additionally, the combination demonstrated higher rates of ≥CR (87.9% vs. 70.1%) and MRD negativity (75.2% vs. 47.5%). The safety profile was consistent with known profiles for DARA SC and VRd, and the study supports the combination of DARA plus VRd followed by D-R maintenance as a new standard of care for transplant-eligible NDMM, building on the findings from the phase 2 GRIFFIN study.
Trial information: Abstract #LBA-1
Doctor bio:
Pieter Sonneveld, MD, PhD, a world-leading expert in multiple myeloma, is a current Professor of Hematology at the Erasmus University of Rotterdam and Erasmus Medical Center, Rotterdam, Netherlands, where he was also Head of Department from 2011-2017. He obtained his medical degree from the Erasmus University in 1977, before completing a PhD in doxorubicin pharmacology in acute leukemia. Prof. Sonneveld received a Forgaty fellowship and went on to work at the National Cancer Institute, Bethesda, MD.
Prof. Sonneveld is chairman of the HOVON Multiple Myeloma Working Group and the European Myeloma Network, and coordinates myeloma clinical trials for both groups. He has published over 500 peer-reviewed articles and served on the editorial boards of Blood, Leukemia, the European Journal of Cancer and Haematologica. Prof. Sonneveld’s work has been recognized with multiple awards, including the prestigious IMF Robert Kyle Lifetime Achievement Award in 2015 and the Hubertus Wald Award for Cancer Research in 2019.
