NOTE

🌱 created from: treatment of multiple myeloma (MM)

imroz

Isatuximab 2024-06-04

Isatuximab Plus VRd in Patients with Newly Diagnosed Multiple Myeloma Ineligible for Transplantation

Information

• Design: Phase 3, open-label, randomized, controlled, multi-center
• Number of patients: 446
• Patients characteristics: Patients 18 to 80 years of age with newly diagnosed multiple myeloma who were ineligible to undergo transplantation
• Agent: Isatuximab plus bortezomib, lenalidomide, and dexamethasone (VRd) vs VRd alone
• Treatment line: First-line therapy
• Trial Name or NCT Number: IMROZ (NCT03319667)

Comparison of two groups

Endpoint	Isatuximab-VRd	VRd
Progression-Free Survival at 60 months	63.2%	45.2%
Hazard Ratio for Disease Progression or Death	0.60 (98.5% CI, 0.41 to 0.88); P<0.001	-
Complete Response or Better	74.7%	64.1%; P=0.01
Minimal Residual Disease (MRD)–Negative Status in Patients with Complete Response	55.5%	40.9%; P=0.003

Other findings

• No new safety signals were observed with the isatuximab-VRd regimen
• The incidence of serious adverse events during treatment and the incidence of adverse events leading to discontinuation were similar in the two groups

Summary In this phase 3 trial, the addition of isatuximab to the VRd regimen significantly improved progression-free survival, complete response or better, and minimal residual disease-negative status in patients with newly diagnosed multiple myeloma who were ineligible to undergo transplantation.