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.
|Journal||Clinical Lymphoma, Myeloma and Leukemia|
|Publication status||Published - 2022 Aug|
Bibliographical noteFunding Information:
This study was funded by Sanofi, Cambridge, MA, USA. Medical writing support, under the guidance of the authors, was provided by Sally-Anne Mitchell, PhD, McCann Health CMC, Japan, and Robert Morgan, MSc, CMC Connect, McCann Health Medical Communications, and was funded by Sanofi, Tokyo, Japan in accordance with Good Publication Practice (GPP3) guidelines (Ann Intern Med 2015; 163:461-464).
All Science Journal Classification (ASJC) codes
- Cancer Research