Phase 3 IMROZ Trial Spotlights Isa-VRd Survival Benefit for Patients With Newly Diagnosed Myeloma

Isatuximab added to bortezomib, lenalidomide, and dexamethasone (Isa-VRd) showed a significant progression-free survival (PFS) benefit for patients with newly diagnosed multiple myeloma, according to the phase 3 IMROZ study.

The results were presented at the European Hematology Association 2025 Congress by Meletios A. Dimopoulos, MD, of the National and Kapodistrian University of Athens.

A total of 446 patients were randomized 3:2 to receive Isa-VRd followed by Isa-Rd maintenance (n=265) or VRd followed by Rd (n=181). In the study, 35.9% of patients in the Isa-VRd group and 38.7% of patients in the VRd group had 1q21+ status, including gain(1q21) and amp(1q21). At least one high-risk cytogenetic abnormality was seen in 7.2% of patients in the Isa-VRd arm and 8.3% in the VRd arm.

Isa-VRd prolonged PFS for patients with 1q21+ or isolated 1q21+ compared with VRd. The median PFS was not reached in the Isa-VRd arm for patients with 1q21+, isolated 1q21+, and standard risk myeloma. Meanwhile, the median PFS in the VRd arm was 39.13 months for patients with 1q21+, 43.01 months for those with isolated 1q21+, and 53.91 months for those with standard risk.

Isa-VRd also showed higher rates of complete response (CR) and measurable residual disease (MRD) negativity at 10^-5 sensitivity. In the Isa-VRd arm, 76.9% of patients with 1q21+, 78.7% of patients with isolated 1q21+, and 72.5% of patients with standard risk achieved a CR or better. The MRD rates were 63.2% versus 41.4% for 1q21+, 65.3% versus 40.0% for isolated 1q21+, and 58.9% versus 40.7% for standard risk, respectively.

“These findings are in line with similar analyses done with Isa-pomalidomide-dexamethasone and Isa-carfilzomib-dexamethasone in phase 3 studies,” Dr. Dimopoulos and colleagues concluded.