In the phase 3 IKEMA study (NCT03275285), isatuximab (Isa) plus carfilzomib (K) and dexamethasone (d) significantly improved progression-free survival (PFS) in relapsed multiple myeloma (MM), compared with Kd. This IKEMA subgroup analysis evaluated efficacy and safety of Isa-Kd versus Kd among East Asian patients. Eligible patients had 1–3 prior lines of therapy and were stratified by number of prior lines and revised International Staging System. The primary endpoint was PFS. Key secondary endpoints included overall response, very good partial response or better (≥VGPR), minimal residual disease (MRD) negativity, and complete response (CR) rate. Forty-six East Asian patients (19 Japanese, 27 South Korean) were randomized to Isa-Kd (n = 25) or Kd (n = 21). Isa-Kd improved PFS (HR 0.64; 95% CI 0.23–1.76), ≥VGPR (80.0% vs 52.4%), MRD negativity rate (44.0% vs 9.5%), and CR (44.0% vs 23.8%). The rate of grade ≥ 3 treatment-emergent adverse events (TEAEs) was 79% for Isa-Kd versus 55% for Kd. The rate of serious TEAEs was 46% versus 50%, and the rate of TEAEs leading to treatment discontinuation was 4% versus 10%. Overall, Isa-Kd improved efficacy and safety versus Kd in East Asian patients with relapsed MM, consistent with the overall IKEMA population.
|Number of pages||10|
|Journal||International Journal of Hematology|
|Publication status||Published - 2022 Oct|
Bibliographical noteFunding Information:
KK reports grants from Janssen and BMS, outside the submitted work. KI reports grants from Sanofi, Novartis, AbbVie, Bayer, and SymBio; and personal fees from Takeda, Celgene, ONO, Novartis, Chugai, and Eisai, outside the submitted work. YK reports personal fees and non-financial support from Sanofi during the conduct of the study; and personal fees from Janssen, Bristol Myers Squibb, and ONO, outside the submitted work. PM reports personal fees from Sanofi during the conduct of the study; and personal fees from Celgene, Amgen, and Janssen, outside the submitted work. TM reports research support for his institution from Sanofi and Amgen. YD and M-LR are employees of Sanofi and may hold stock/shares in the company. KS reports personal fees and other support from Celgene; personal fees from Takeda, ONO, Amgen, Novartis, Sanofi, AbbVie and Janssen; personal fees and non-financial support from BMS during the conduct of the study. C-KM, YK, S-HK, SI, JT, MU, and JSK have nothing to disclose.
© 2022, Japanese Society of Hematology.
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