Isatuximab plus carfilzomib and dexamethasone in East Asian patients with relapsed multiple myeloma: IKEMA subgroup analysis

Kihyun Kim, Chang Ki Min, Youngil Koh, Kenichi Ishizawa, Sung Hyun Kim, Shigeki Ito, Junji Tanaka, Michihiro Uchiyama, Yawara Kawano, Jin Seok Kim, Philippe Moreau, Thomas Martin, Yvonne Dong, Marie Laure Risse, Kenshi Suzuki

Research output: Contribution to journalArticlepeer-review

Abstract

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.

Original languageEnglish
Pages (from-to)553-562
Number of pages10
JournalInternational Journal of Hematology
Volume116
Issue number4
DOIs
StatePublished - Oct 2022

Keywords

  • East Asian patients
  • IKEMA study
  • Isatuximab
  • Relapsed multiple myeloma

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