Isatuximab-Pomalidomide-Dexamethasone Versus Pomalidomide-Dexamethasone in East Asian Patients With Relapsed/Refractory Multiple Myeloma: ICARIA-MM Subgroup Analysis

Data from the phase III ICARIA-MM study in patients with relapsed/refractory multiple myeloma demonstrated significant improvements in progression-free survival and response rates with isatuximab plus pomalidomide and dexamethasone (Isa-Pd) versus pomalidomide and dexamethasone. This predefined subgroup analysis confirmed the efficacy and safety of Isa-Pd in Japanese, Korean, and Taiwanese patients, supporting the use of this treatment combination in East Asia. Background: In the pivotal phase III, randomized, multicenter ICARIA-MM study (NCT02990338), isatuximab plus pomalidomide and dexamethasone (Isa-Pd) improved progression-free survival and overall response rate versus pomalidomide and dexamethasone (Pd) in the overall population of patients with relapsed/refractory multiple myeloma. Patients and Methods: In this predefined subgroup analysis, efficacy, and safety between East Asian patients and the overall population were assessed. Results: In total, 36 East Asian patients were included (Japanese, n = 13; Korean, n = 9; Taiwanese, n = 14). At a median follow-up of 11.6 months, median progression-free survival was not reached (95% confidence interval [CI] 5.80-not calculable) in the Isa-Pd arm and was 7.9 months (95% CI 2.90-not calculable) in the Pd arm. The hazard ratio for the between-group difference was 0.52 (95% CI 0.19-1.39), which was similar to the overall population (hazard ratio, 0.60; 95% CI 0.44-0.82). No new safety signals were observed, except that a higher proportion of patients in the East Asian population experienced Grade >= 3 neutropenia compared with the overall population. Conclusion: These results confirm the efficacy of Isa-Pd in East Asian patients with relapsed/refractory multiple myeloma, and the related safety data are consistent with those observed in the overall population and are manageable. (C) 2022 The Author(s). Published by Elsevier Inc.