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- Title
Isatuximab-Pomalidomide-Dexamethasone Versus Pomalidomide-Dexamethasone in East Asian Patients With Relapsed/Refractory Multiple Myeloma: ICARIA-MM Subgroup Analysis.
- Authors
Sunami, Kazutaka; Ikeda, Takashi; Huang, Shang-Yi; Wang, Ming-Chung; Koh, Youngil; Min, Chang Ki; Yeh, Su-Peng; Matsumoto, Morio; Uchiyama, Michihiro; Iyama, Satoshi; Shimazaki, Chihiro; Lee, Jae Hoon; Kim, Kihyun; Kaneko, Hitomi; Kim, Jin Seok; Lin, Tung-Liang; Campana, Frank; Tada, Keisuke; Iida, Shinsuke; Suzuki, Kenshi
- Abstract
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.
- Publication
Clinical Lymphoma, Myeloma & Leukemia, 2022, Vol 22, Issue 8, pe751
- ISSN
2152-2650
- Publication type
Article
- DOI
10.1016/j.clml.2022.04.005