Dr Facon on the Implications of Isatuximab Plus VRd in Transplant-Ineligible Newly Diagnosed Myeloma

Thierry Facon, MD, professor, hematology, Department of Hematology, Lille University Hospital, discusses the clinical implications from the phase 3 IMROZ trial (NCT03319667) investigating isatuximab-irfc (Sarclisa) plus bortezomib (Velcade), lenalidomide (Revlimid), and dexamethasone (Isa-VRd) in patients with transplant-ineligible, newly diagnosed multiple myeloma.

Facon highlights that during the trial, Isa-VRd demonstrated notable efficacy, particularly in terms of progression-free survival (PFS) improvements compared with VRd, suggesting that Isa-VRd has the potential to become a new standard of care for patients under 80 years of age with newly diagnosed multiple myeloma who are not candidates for autologous stem cell transplantation, which was the patient population enrolled on the study.

Findings from IMROZ presented at the 2024 ASCO Annual Meeting showed a statistically improvement in PFS with Isa-VRd vs VRd along (HR, 0.596; 98.5% CI, 0.406-0.876; log-rank P = .0005). Isa-VRd (n = 265) led to a median PFS that was not reached (NR) vs 54.34 months (95% CI, 45.207-NR) for VRd alone (n = 181).

Beyond the improvement in PFS, Facon notes that Isa-VRd elicited deep responses, with improvements in complete response (CR) or better rate and minimal residual disease (MRD) negativity rates. The overall response rate was 91.3% for Isa-VRd vs 92.3% for VRd alone; however, the CR or better rate was 74.7% in the Isa-VRd arm vs 64.1% in the VRd arm.

In the intention-to-treat population, the MRD negativity rate was 58.1% for the Isa-VRd arm vs 43.6% for the VRd arm. The MRD-negative CR rates were 55.5% for Isa-VRd and 40.9% for VRd. MRD negativity was sustained for at least 12 months in 46.8% of patients in the ISA-VRd arm and 24.3% of patients in the VRd arm.

Based on findings from IMROZ, the FDA granted priority review to the supplemental biologics license application seeking the approval of Isa-VRd) for the treatment of patients with newly diagnosed, transplant-ineligible multiple myeloma.