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DOI 10.1016/j.clml.2023.06.011

Медицинская библиотека · Clinical lymphoma, myeloma & leukemia · 2023

Isatuximab Plus Carfilzomib and Dexamethasone in East Asian Patients With Relapsed Multiple Myeloma: Updated IKEMA Subgroup Analysis.

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

Клиническое исследование III фазыСтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАПеревод пока не подготовлен

Аннотация

BACKGROUND

The Phase 3 IKEMA study (NCT03275285) demonstrated isatuximab (Isa) in combination with carfilzomib (K) and dexamethasone (d) significantly improved progression-free survival (PFS) in patients with relapsed multiple myeloma (MM) compared with Kd. A post-hoc analysis of East Asian patients in IKEMA evaluated the efficacy and safety of Isa-Kd versus Kd in this population and was previously published.

PATIENTS AND

METHODS

Patients with relapsed MM who had received 1 to 3 prior lines of therapy were randomized 3:2 to receive Isa-Kd or Kd. The primary endpoint was PFS, and key secondary endpoints included rate of very good partial response or better (≥VGPR), complete response (CR) rate, and minimal residual disease (MRD) negativity. Of the IKEMA overall population, 46 patients were of East Asian descent. This is an updated analysis of the efficacy and safety of Isa-Kd in East Asian patients, including data through 14 January 2022.

RESULTS

Isa-Kd continued to demonstrate improved efficacy and safety versus Kd in East Asian patients with relapsed MM, with improved PFS, rate of ≥VGPR, CR rate, and MRD negativity, that was consistent with the overall IKEMA population. The rate of Grade ≥3 treatment-emergent adverse events was also consistent with the prior analysis and overall IKEMA population.

CONCLUSION

Based on the results of this analysis, Isa-Kd is a novel treatment option for East Asian patients with relapsed MM.

Для цитирования: Kawano Yawara, Kim Kihyun, Min Chang Ki, Koh Youngil, Ishizawa Kenichi, Kim Sung Hyun, Ito Shigeki, Tanaka Junji, Uchiyama Michihiro, Ishida Tadao, Kim Jin Seok, Moreau Philippe, Martin Thomas, Tada Keisuke, Risse Marie-Laure, Suzuki Kenshi. Isatuximab Plus Carfilzomib and Dexamethasone in East Asian Patients With Relapsed Multiple Myeloma: Updated IKEMA Subgroup Analysis.. Clinical lymphoma, myeloma & leukemia. 2023. DOI: 10.1016/j.clml.2023.06.011.

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