Isatuximab-Pomalidomide-Dexamethasone Versus Pomalidomide-Dexamethasone in East Asian Patients With Relapsed/Refractory Multiple Myeloma: ICARIA-MM Subgroup Analysis

ICARIA-MM study group

doi:10.1016/j.clml.2022.04.005

Isatuximab-Pomalidomide-Dexamethasone Versus Pomalidomide-Dexamethasone in East Asian Patients With Relapsed/Refractory Multiple Myeloma: ICARIA-MM Subgroup Analysis

ICARIA-MM study group

Research output: Contribution to journal › Article › peer-review

3 Scopus citations

Abstract

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.

Original language	English
Pages (from-to)	e751-e761
Journal	Clinical Lymphoma, Myeloma and Leukemia
Volume	22
Issue number	8
DOIs	https://doi.org/10.1016/j.clml.2022.04.005
State	Published - Aug 2022

Bibliographical note

Funding Information:
This study was funded by Sanofi, Cambridge, MA, USA. Medical writing support, under the guidance of the authors, was provided by Sally-Anne Mitchell, PhD, McCann Health CMC, Japan, and Robert Morgan, MSc, CMC Connect, McCann Health Medical Communications, and was funded by Sanofi, Tokyo, Japan in accordance with Good Publication Practice (GPP3) guidelines (Ann Intern Med 2015; 163:461-464).

Publisher Copyright:
© 2022

Keywords

Efficacy and safety
Far East
Isa-Pd
Japan
RRMM

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1016/j.clml.2022.04.005

Cite this

@article{b489cfb7e73444fe91486992c62f8dd8,

title = "Isatuximab-Pomalidomide-Dexamethasone Versus Pomalidomide-Dexamethasone in East Asian Patients With Relapsed/Refractory Multiple Myeloma: ICARIA-MM Subgroup Analysis",

abstract = "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.",

keywords = "Efficacy and safety, Far East, Isa-Pd, Japan, RRMM",

author = "{ICARIA-MM study group} and Kazutaka Sunami and Takashi Ikeda and Huang, {Shang Yi} and Wang, {Ming Chung} and Youngil Koh and Min, {Chang Ki} and Yeh, {Su Peng} and Morio Matsumoto and Michihiro Uchiyama and Satoshi Iyama and Chihiro Shimazaki and Lee, {Jae Hoon} and Kihyun Kim and Hitomi Kaneko and Kim, {Jin Seok} and Lin, {Tung Liang} and Frank Campana and Keisuke Tada and Shinsuke Iida and Kenshi Suzuki",

note = "Funding Information: This study was funded by Sanofi, Cambridge, MA, USA. Medical writing support, under the guidance of the authors, was provided by Sally-Anne Mitchell, PhD, McCann Health CMC, Japan, and Robert Morgan, MSc, CMC Connect, McCann Health Medical Communications, and was funded by Sanofi, Tokyo, Japan in accordance with Good Publication Practice (GPP3) guidelines (Ann Intern Med 2015; 163:461-464). Publisher Copyright: {\textcopyright} 2022",

year = "2022",

month = aug,

doi = "10.1016/j.clml.2022.04.005",

language = "English",

volume = "22",

pages = "e751--e761",

journal = "Clinical Lymphoma, Myeloma and Leukemia",

issn = "2152-2650",

publisher = "Elsevier Inc.",

number = "8",

}

TY - JOUR

T1 - Isatuximab-Pomalidomide-Dexamethasone Versus Pomalidomide-Dexamethasone in East Asian Patients With Relapsed/Refractory Multiple Myeloma

T2 - ICARIA-MM Subgroup Analysis

AU - ICARIA-MM study group

AU - Sunami, Kazutaka

AU - Ikeda, Takashi

AU - Huang, Shang Yi

AU - Wang, Ming Chung

AU - Koh, Youngil

AU - Min, Chang Ki

AU - Yeh, Su Peng

AU - Matsumoto, Morio

AU - Uchiyama, Michihiro

AU - Iyama, Satoshi

AU - Shimazaki, Chihiro

AU - Lee, Jae Hoon

AU - Kim, Kihyun

AU - Kaneko, Hitomi

AU - Kim, Jin Seok

AU - Lin, Tung Liang

AU - Campana, Frank

AU - Tada, Keisuke

AU - Iida, Shinsuke

AU - Suzuki, Kenshi

N1 - Funding Information: This study was funded by Sanofi, Cambridge, MA, USA. Medical writing support, under the guidance of the authors, was provided by Sally-Anne Mitchell, PhD, McCann Health CMC, Japan, and Robert Morgan, MSc, CMC Connect, McCann Health Medical Communications, and was funded by Sanofi, Tokyo, Japan in accordance with Good Publication Practice (GPP3) guidelines (Ann Intern Med 2015; 163:461-464). Publisher Copyright: © 2022

PY - 2022/8

Y1 - 2022/8

N2 - 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.

AB - 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.

KW - Efficacy and safety

KW - Far East

KW - Isa-Pd

KW - Japan

KW - RRMM

UR - http://www.scopus.com/inward/record.url?scp=85131126183&partnerID=8YFLogxK

U2 - 10.1016/j.clml.2022.04.005

DO - 10.1016/j.clml.2022.04.005

M3 - Article

C2 - 35641409

AN - SCOPUS:85131126183

SN - 2152-2650

VL - 22

SP - e751-e761

JO - Clinical Lymphoma, Myeloma and Leukemia

JF - Clinical Lymphoma, Myeloma and Leukemia

IS - 8

ER -

Isatuximab-Pomalidomide-Dexamethasone Versus Pomalidomide-Dexamethasone in East Asian Patients With Relapsed/Refractory Multiple Myeloma: ICARIA-MM Subgroup Analysis

Abstract

Bibliographical note

Keywords

UN SDGs

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