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Efficacy of Isa-VRd as first-line therapy in newly diagnosed MM
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The FDA has approved Isa-VRd for adult patients with NDMM who are not eligible for ASCT.1 However, the efficacy of anti-CD38 agents combined with VRd in patients with NDMM who are transplant eligible remains uncertain. The phase III IMROZ trial (NCT03319667) evaluated the safety and efficacy of the quadruplet therapy Isa-VRd vs VRd in 446 adult patients with NDMM who were eligible for transplantation. The primary endpoint was PFS, and key secondary endpoints included CR and MRD-negative CR. Results were published in The New England Journal of Medicine by Facon et al.1 |
| Key learnings |
| With a median follow-up of 59.7 months, the estimated PFS at 60 months was 63.2% vs 45.2% in the Isa-VRd and VRd groups, respectively (HR, 0.60; 95% CI, 0.41–0.88; p < 0.001). |
| CR rates (74.7% vs 64.1%; p = 0.01) and MRD-negative CR rates (55.5% vs 40.9%; p = 0.003) were higher in the Isa-VRd group compared with the VRd group. |
| The incidence of AEs leading to treatment discontinuation (22.8% vs 26.0%) and SAEs (70.7% vs 67.4%) was similar in the Isa-VRd and VRd groups. |
| These findings show deep responses and a PFS benefit with first-line Isa-VRd compared with VRd therapy. The safety profile of Isa-VRd was comparable to current standard of care treatments. |
Abbreviations: AE, adverse event; ASCT, autologous stem cell transplant; CI, confidence interval; CR, complete response; FDA, U.S. Food and Drug Administration; HR, hazard ratio; Isa, isatuximab; MRD, measurable residual disease; NDMM, newly diagnosed multiple myeloma; PFS, progression-free survival; SAE, serious adverse event; VRd, bortezomib, lenalidomide, dexamethasone.
- Facon T, Dimopoulos MA, Leleu XP, et al. Isatuximab, bortezomib, lenalidomide, and dexamethasone for multiple myeloma. N Engl J Med. 2024;391(17):1597-1609. DOI:
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