Novel standard-of-care in newly diagnosed MM

Daratumumab added to bortezomib, lenalidomide, and dexamethasone (VRd) outperformed VRd alone in participants with previously untreated multiple myeloma (MM) who were eligible for autologous stem cell transplantation (autoSCT). Improvements were seen in progression-free survival (PFS), complete response (CR), and minimal residual disease (MRD) negativity rates. According to the authors, a new standard-of-care has arrived for this patient population.

“AutoSCT has been the first-choice therapy option for transplant-eligible patients with newly diagnosed MM for over 20 years, and VRd induction, followed by transplant, VRd consolidation, and R maintenance is considered standard-of-care,” presented speaker Prof. Pieter Sonneveld (Erasmus MC, the Netherlands).

The phase 3 Perseus trial (NCT03710603) randomised 709 autoSCT-eligible participants with previously untreated MM 1:1 to VRd or VRd plus subcutaneously administered daratumumab (D-VRd). “Daratumumab was added in the induction phase, the consolidation phase, and during the maintenance phase,” clarified Prof. Sonneveld. PFS was the primary endpoint of the trial [1].

After a median follow-up of 47.5 months, D-VRd was superior to VRd regarding PFS (HR 0.42; 95% CI 0.30–0.59; P<0.0001; see Figure). The estimated 48-month PFS rates were 84.3% and 67.7%. The CR rates favoured the D-VRd arm over the VRd arm (87.9% vs 70.1%) and the sustained MRD negativity (10^-5; ≥12 months) rates were 64.8% and 29.7% in the D-VRd and VRd arms, respectively. Deep and durable MRD negativity was reached with D-VRd: 64% of participants receiving maintenance therapy in the D-VRd group discontinued daratumumab after achieving sustained MRD negativity per protocol.

Figure: Progression-free survival over time for participants treated with D-VRd or VRd in PERSEUS trial [1]



D-VRd, daratumumab added to bortezomib, lenalidomide, and dexamethasone; PFS, progression-free survival; VRd, bortezomib, lenalidomide, and dexamethasone.

The safety profile of D-VRd was consistent with the established safety profiles of subcutaneously administered daratumumab and VRd.

“The results of the current phase 3 trial show that D-VRd followed by daratumumab maintenance presents a novel standard-of-care for transplant-eligible patients with previously untreated MM,” concluded Prof. Sonneveld.

1. Sonneveld P, et al. 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. Abstract LBA-1, 65^th ASH Annual Meeting, 9–12 December 2023, San Diego, CA, USA.

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Posted on 6 February, 202415 February, 2024