MM-093: Isatuximab Updates for Nurses: Isatuximab (Isa) Plus Carfilzomib (K) and Dexamethasone (d) Versus Carfilzomib and Dexamethasone in Relapsed Multiple Myeloma Patients (IKEMA)

Abstract

Background Based on the ICARIA-MM study, Isa-pomalidomide-d is approved in relapsed/refractory multiple myeloma (RRMM) after ≥ 2 prior therapies, including lenalidomide and proteasome inhibitor. Isa can be administered as a 250 mL fixed-volume infusion with a median infusion time of 75 minutes for the third and subsequent infusions. Based on IKEMA study, Isa-Kd is approved in the US for RRMM after 1–3 prior lines of therapy and in EU for relapsed MM after ≥1 prior therapy. Here, we review the IKEMA data including specific considerations for nurses. Methods 302 patients with 1–3 prior lines of therapy were randomized (179 Isa-Kd, 123 Kd). Nurses should ensure blood typing, and premedication (to reduce the risk of infusion reactions [IRs]). Isa was administered intravenously (using a 0.20-pm filter) at 10 mg/kg weekly for 4 weeks, and every other week thereafter. Vigilance is required for IR detection and their management, and nurses must provide patient education. Results In a pre-specified interim analysis, PFS was significantly improved in patients receiving Isa-Kd with the median not reached for Isa-Kd vs 19.2 months with Kd (HR 0.53; 99% CI: 0.32–0.89; one-sided p=0.0007). Overall response rate: 86.6% Isa-Kd vs 82.9% Kd, one-sided p=0.1930. Very good partial response or better: 72.6% Isa-Kd vs 56.1% Kd, p=0.0011. Minimal residual disease negative (10–5): 29.6% Isa-Kd vs 13.0% Kd, p=0.0004. More patients were still on treatment with Isa-Kd (52.0%) vs Kd (30.9%). Grade ≥3 treatment-emergent adverse events (TEAEs): 76.8% Isa-Kd vs 67.2% Kd. Serious TEAEs and fatal TEAEs were similar in Isa-Kd vs Kd: 59.3% vs 57.4% and 3.4% vs 3.3%, respectively. IRs: 45.8% (0.6%, Grade 3–4) Isa-Kd and 3.3% (0%, Grade 3–4) Kd. Most frequent Grade ≥3 TEAEs were hypertension and pneumonia: 20.3% and 16.4% Isa-Kd vs 19.7% and 12.3% Kd, respectively. Grade 3-4 thrombocytopenia and neutropenia: 29.9% Isa-Kd vs 23.8% Kd and 19.2% Isa-Kd vs 7.4% Kd, respectively. As measured by QLQ-C30 Global Health Status scores, HRQOL was maintained with Isa-Kd. Conclusion The clinical activity and manageable safety profile of Isa offer an important new treatment option for patients with relapsed MM.