Isa-VRd for transplant-ineligible patients with NDMM: Interim results from the IMROZ trial

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  

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.