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The combination of bortezomib, lenalidomide, and dexamethasone (VRd) is considered the standard of care for patients with newly diagnosed (ND) multiple myeloma (MM).1,2 The phase III IMROZ trial (NCT03319667) is evaluating whether addition of isatuximab, an anti-CD38 monoclonal antibody, to the VRd regimen (Isa-VRd) improves outcomes for patients with NDMM who are ineligible for transplantation.1,2 Interim results from this trial were presented by Facon1 during the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and have been published in The New England Journal of Medicine by Facon et al.2 |
Key learnings: |
The IMROZ study met its primary endpoint of PFS: median PFS was not reached at 54.34 months, and the 60-month PFS rate was 63.2% and 45.2%, in the Isa-VRd and VRd arms, respectively. |
After a median follow-up of 5 years, Isa-VRd was associated with a 40.4% reduction in the risk of progression or death vs VRd. |
Isa-VRd was also associated with a higher complete response (CR) rate (74.7% vs 64.1%), a higher measurable residual disease-negative (MRD−) CR rate (55.5% vs 40.9; p = 0.003), and a higher rate of sustained MRD− for ≥12 months (46.8% vs 24.3%) when compared with VRd. |
The improved efficacy with Isa-VRd, combined with a tolerable safety profile, suggests that Isa-VRd could be a new standard of care for transplant-ineligible patients with NDMM. |
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