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

doi:10.1007/s12185-022-03378-w

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

Department of Internal Medicine

Research output: Contribution to journal › Article › peer-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 language	English
Pages (from-to)	553-562
Number of pages	10
Journal	International Journal of Hematology
Volume	116
Issue number	4
DOIs	https://doi.org/10.1007/s12185-022-03378-w
Publication status	Published - 2022 Oct

Bibliographical note

Funding 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.

Publisher Copyright:
© 2022, Japanese Society of Hematology.

All Science Journal Classification (ASJC) codes

Hematology

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10.1007/s12185-022-03378-w

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Kim, K., Min, C. K., Koh, Y., Ishizawa, K., Kim, S. H., Ito, S., Tanaka, J., Uchiyama, M., Kawano, Y., Kim, J. S., Moreau, P., Martin, T., Dong, Y., Risse, M. L., & Suzuki, K. (2022). Isatuximab plus carfilzomib and dexamethasone in East Asian patients with relapsed multiple myeloma: IKEMA subgroup analysis. International Journal of Hematology, 116(4), 553-562. https://doi.org/10.1007/s12185-022-03378-w

@article{e0643a6c64fb41dbb8f0b33169896946,

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

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.",

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

note = "Funding 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. Publisher Copyright: {\textcopyright} 2022, Japanese Society of Hematology.",

year = "2022",

month = oct,

doi = "10.1007/s12185-022-03378-w",

language = "English",

volume = "116",

pages = "553--562",

journal = "International Journal of Hematology",

issn = "0925-5710",

publisher = "Springer Japan",

number = "4",

}

Kim, K, Min, CK, Koh, Y, Ishizawa, K, Kim, SH, Ito, S, Tanaka, J, Uchiyama, M, Kawano, Y, Kim, JS, Moreau, P, Martin, T, Dong, Y, Risse, ML & Suzuki, K 2022, 'Isatuximab plus carfilzomib and dexamethasone in East Asian patients with relapsed multiple myeloma: IKEMA subgroup analysis', International Journal of Hematology, vol. 116, no. 4, pp. 553-562. https://doi.org/10.1007/s12185-022-03378-w

TY - JOUR

T1 - Isatuximab plus carfilzomib and dexamethasone in East Asian patients with relapsed multiple myeloma

T2 - IKEMA subgroup analysis

AU - Kim, Kihyun

AU - Min, Chang Ki

AU - Koh, Youngil

AU - Ishizawa, Kenichi

AU - Kim, Sung Hyun

AU - Ito, Shigeki

AU - Tanaka, Junji

AU - Uchiyama, Michihiro

AU - Kawano, Yawara

AU - Kim, Jin Seok

AU - Moreau, Philippe

AU - Martin, Thomas

AU - Dong, Yvonne

AU - Risse, Marie Laure

AU - Suzuki, Kenshi

N1 - Funding 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. Publisher Copyright: © 2022, Japanese Society of Hematology.

PY - 2022/10

Y1 - 2022/10

N2 - 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.

AB - 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.

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AN - SCOPUS:85130154224

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JO - International Journal of Hematology

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IS - 4

ER -

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

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