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Clinically Meaningful Benefit Observed with Isatuximab plus Pomalidomide and Dexamethasone in Patients with RRMM: ICARIA-MM Final OS Analysis

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ICARIA-MM is a phase 3, randomized, multicenter, open-label study that evaluated isatuximab plus pomalidomide and dexamethasone (Isa-Pd) versus pomalidomide and dexamethasone alone (Pd) in patients with relapsed/refractory multiple myeloma (RRMM). An updated overall survival (OS) analysis, presented at the 2022 International Myeloma Society meeting, demonstrated a clinically meaningful OS benefit and manageable safety profile with Isa-Pd compared with Pd alone.

A total of 101 patients in the Isa-Pd group and 117 patients in the Pd group had discontinued treatment due to disease progression. Median treatment duration with Isa-Pd was 47.6 weeks versus 24.0 weeks with Pd alone. A total of 16 Isa-Pd patients (10.4%) and 3 Pd patients (2.0%) were still on treatment at data cutoff (March 2022). After a median follow-up of 52.4 months and 220 events, median OS was 24.6 months with Isa-Pd versus 17.7 months with Pd alone (hazard ratio [HR], 0.776; 95% confidence interval [CI], 0.594-1.1015; one-sided P = .0319; significance level, P = .02). These data demonstrated a clinically meaningful 6.9-month improvement with Isa-Pd treatment. Median time to next treatment with Isa-Pd and Pd was 15.5 months and 8.9 months, respectively (HR, 0.548; 95% CI, 0.417-0.718). Progression or death on subsequent treatment (PFS2) was longer with Isa-Pd compared with Pd alone: median PFS2 was 17.5 months for Isa-Pd versus 12.9 months for Pd (HR, 0.735; 95% CI, 0.569-0.950).

The safety profile was manageable and consistent with prior ICARIA-MM analyses. Grade ≥3 adverse events (AEs) were reported in 90.8% of the Isa-Pd group and 73.7% of the Pd group. Grade 3/4 neutropenia occurred in 84.9% of the Isa-Pd group, and grade 3/4 thrombocytopenia occurred in 34.2% of the Isa-Pd group versus 71.4% and 25.2% of patients, respectively, in the Pd group. Serious treatment-emergent AEs (TEAEs) were also higher in the Isa-Pd group compared with Pd alone (73.7% versus 61.1%), but discontinuation of therapy due to TEAEs or death was not increased with Isa-Pd (12.5% and 9.9% in the Isa-Pd group, respectively, versus 14.8% and 10.7% in the Pd group, respectively). The most common nonhematologic TEAE with Isa-Pd was infusion reaction (37.5% of patients). Other common nonhematologic TEAEs included upper respiratory tract infections, diarrhea, pneumonia, and bronchitis. The incidence of second primary malignancies (SPMs) was higher with Isa-Pd; however, no new cases had developed since the interim OS analysis and SPM did not negatively impact OS.

The final OS analysis supports the use of Isa-Pd as standard of care in patients with RRMM as supported by clinically meaningful OS benefit with no new safety signals.

Source:

Richardson P, Perrot A, San-Miguel J, et al. Isatuximab plus pomalidomide/low-dose dexamethasone versus pomalidomide/low-dose dexamethasone in patients with relapsed/refractory multiple myeloma (ICARIA-MM): final overall survival analysis. Oral abstract presented at: International Myeloma Foundation; August 25-27, 2022; Los Angeles, CA.

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