Carfilzomib, dexamethasone, and daratumumab in Asian patients with relapsed or refractory multiple myeloma: post hoc subgroup analysis of the phase 3 CANDOR trial

Kenshi Suzuki; Chang Ki Min; Kihyun Kim; Je Jung Lee; Hirohiko Shibayama; Po Shen Ko; Shang Yi Huang; Sin Syue Li; Bifeng Ding; Monica Khurana; Shinsuke Iida

doi:10.1007/s12185-021-03204-9

Carfilzomib, dexamethasone, and daratumumab in Asian patients with relapsed or refractory multiple myeloma: post hoc subgroup analysis of the phase 3 CANDOR trial

Kenshi Suzuki, Chang Ki Min, Kihyun Kim, Je Jung Lee, Hirohiko Shibayama, Po Shen Ko, Shang Yi Huang, Sin Syue Li, Bifeng Ding, Monica Khurana, Shinsuke Iida

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Abstract

Background: Due to increasing use of frontline lenalidomide, effective and safe lenalidomide-free therapies for relapsed/refractory multiple myeloma (RRMM) are needed in Asia. This subgroup analysis of phase 3 CANDOR study evaluated efficacy and safety of KdD vs Kd in Asian patients with RRMM. Methods: Self-identified Asian patients with RRMM (KdD = 46; Kd = 20) with 1‒3 prior therapies were included. The primary endpoint of progression-free survival was estimated by stratified Cox regression. Results: Baseline demographics and patient characteristics were balanced in both arms. KdD reduced the risk of progression or death by 25% vs Kd [hazard ratio (HR) = 0.75; 95% CI 0.259, 2.168] in the Asian subgroup, compared with 37% vs Kd (0.63; 0.464, 0.854) in the overall CANDOR population. Percentage of patients who reported grade ≥ 3 treatment-emergent adverse events (TEAEs) in the KdD and Kd arms was 95.7 and 90.0%, respectively. Serious AEs were observed in 58.7 and 40.0% of patients in the KdD and Kd arms, respectively. There were two (4.3%) fatal TEAEs in the KdD arm due to infections. Conclusions: There was a trend toward better efficacy and a favorable benefit-risk profile for KdD vs Kd in Asian patients with RRMM. Cautious interpretation is warranted due to small patient size.

Original language	English
Pages (from-to)	653-663
Number of pages	11
Journal	International Journal of Hematology
Volume	114
Issue number	6
DOIs	https://doi.org/10.1007/s12185-021-03204-9
State	Published - Dec 2021

Bibliographical note

Funding Information:
HS has received honoraria from Takeda, Ono, Novartis, Celgene, Janssen, Chugai, Sanofi, AstraZeneca and Kyowa Kirin; research funding from Janssen, Ono, Celgene, Novartis, Sanofi, AstraZeneca, AbbVie, and Chugai; and scholarship endowment from Astellas, Teijin, Shionogi, Eisai, Sanofi, Taiho, and Nippon Shinyaku. SI received grants and personal fees from Ono; received grants and fees from Takeda, Janssen, Celgene, Sanofi, Bristol-Myers Squibb, and Daiichi Sankyo during the conduct of this study; received grants from Chugai, Kyowa Kirin, and AbbVie, outside the submitted work. KS , C-KM , KK , J-JL , P-SK , S-YH , BD , MK , and S-SL have nothing to report.

Funding Information:
We thank the patients who participated in the CANDOR trial and the staff at the trial sites who cared for them. Medical writing support, in accordance with the GPP3 guidelines, was provided by Swapnil Kher, PhD, of Cactus Life Sciences (part of Cactus Communications) and was funded by Amgen Inc.

Publisher Copyright:
© 2021, Japanese Society of Hematology.

Keywords

Asian population
CANDOR trial
Carfilzomib
Daratumumab
Relapsed refractory multiple myeloma

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10.1007/s12185-021-03204-9

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Suzuki, K., Min, C. K., Kim, K., Lee, J. J., Shibayama, H., Ko, P. S., Huang, S. Y., Li, S. S., Ding, B., Khurana, M., & Iida, S. (2021). Carfilzomib, dexamethasone, and daratumumab in Asian patients with relapsed or refractory multiple myeloma: post hoc subgroup analysis of the phase 3 CANDOR trial. International Journal of Hematology, 114(6), 653-663. https://doi.org/10.1007/s12185-021-03204-9

@article{1943f6064f8f47369d3b54b5a4e0d55c,

title = "Carfilzomib, dexamethasone, and daratumumab in Asian patients with relapsed or refractory multiple myeloma: post hoc subgroup analysis of the phase 3 CANDOR trial",

abstract = "Background: Due to increasing use of frontline lenalidomide, effective and safe lenalidomide-free therapies for relapsed/refractory multiple myeloma (RRMM) are needed in Asia. This subgroup analysis of phase 3 CANDOR study evaluated efficacy and safety of KdD vs Kd in Asian patients with RRMM. Methods: Self-identified Asian patients with RRMM (KdD = 46; Kd = 20) with 1‒3 prior therapies were included. The primary endpoint of progression-free survival was estimated by stratified Cox regression. Results: Baseline demographics and patient characteristics were balanced in both arms. KdD reduced the risk of progression or death by 25% vs Kd [hazard ratio (HR) = 0.75; 95% CI 0.259, 2.168] in the Asian subgroup, compared with 37% vs Kd (0.63; 0.464, 0.854) in the overall CANDOR population. Percentage of patients who reported grade ≥ 3 treatment-emergent adverse events (TEAEs) in the KdD and Kd arms was 95.7 and 90.0%, respectively. Serious AEs were observed in 58.7 and 40.0% of patients in the KdD and Kd arms, respectively. There were two (4.3%) fatal TEAEs in the KdD arm due to infections. Conclusions: There was a trend toward better efficacy and a favorable benefit-risk profile for KdD vs Kd in Asian patients with RRMM. Cautious interpretation is warranted due to small patient size.",

keywords = "Asian population, CANDOR trial, Carfilzomib, Daratumumab, Relapsed refractory multiple myeloma",

author = "Kenshi Suzuki and Min, {Chang Ki} and Kihyun Kim and Lee, {Je Jung} and Hirohiko Shibayama and Ko, {Po Shen} and Huang, {Shang Yi} and Li, {Sin Syue} and Bifeng Ding and Monica Khurana and Shinsuke Iida",

note = "Funding Information: HS has received honoraria from Takeda, Ono, Novartis, Celgene, Janssen, Chugai, Sanofi, AstraZeneca and Kyowa Kirin; research funding from Janssen, Ono, Celgene, Novartis, Sanofi, AstraZeneca, AbbVie, and Chugai; and scholarship endowment from Astellas, Teijin, Shionogi, Eisai, Sanofi, Taiho, and Nippon Shinyaku. SI received grants and personal fees from Ono; received grants and fees from Takeda, Janssen, Celgene, Sanofi, Bristol-Myers Squibb, and Daiichi Sankyo during the conduct of this study; received grants from Chugai, Kyowa Kirin, and AbbVie, outside the submitted work. KS , C-KM , KK , J-JL , P-SK , S-YH , BD , MK , and S-SL have nothing to report. Funding Information: We thank the patients who participated in the CANDOR trial and the staff at the trial sites who cared for them. Medical writing support, in accordance with the GPP3 guidelines, was provided by Swapnil Kher, PhD, of Cactus Life Sciences (part of Cactus Communications) and was funded by Amgen Inc. Publisher Copyright: {\textcopyright} 2021, Japanese Society of Hematology.",

year = "2021",

month = dec,

doi = "10.1007/s12185-021-03204-9",

language = "English",

volume = "114",

pages = "653--663",

journal = "International Journal of Hematology",

issn = "0925-5710",

publisher = "Springer",

number = "6",

}

Suzuki, K, Min, CK, Kim, K, Lee, JJ, Shibayama, H, Ko, PS, Huang, SY, Li, SS, Ding, B, Khurana, M & Iida, S 2021, 'Carfilzomib, dexamethasone, and daratumumab in Asian patients with relapsed or refractory multiple myeloma: post hoc subgroup analysis of the phase 3 CANDOR trial', International Journal of Hematology, vol. 114, no. 6, pp. 653-663. https://doi.org/10.1007/s12185-021-03204-9

TY - JOUR

T1 - Carfilzomib, dexamethasone, and daratumumab in Asian patients with relapsed or refractory multiple myeloma

T2 - post hoc subgroup analysis of the phase 3 CANDOR trial

AU - Suzuki, Kenshi

AU - Min, Chang Ki

AU - Kim, Kihyun

AU - Lee, Je Jung

AU - Shibayama, Hirohiko

AU - Ko, Po Shen

AU - Huang, Shang Yi

AU - Li, Sin Syue

AU - Ding, Bifeng

AU - Khurana, Monica

AU - Iida, Shinsuke

N1 - Funding Information: HS has received honoraria from Takeda, Ono, Novartis, Celgene, Janssen, Chugai, Sanofi, AstraZeneca and Kyowa Kirin; research funding from Janssen, Ono, Celgene, Novartis, Sanofi, AstraZeneca, AbbVie, and Chugai; and scholarship endowment from Astellas, Teijin, Shionogi, Eisai, Sanofi, Taiho, and Nippon Shinyaku. SI received grants and personal fees from Ono; received grants and fees from Takeda, Janssen, Celgene, Sanofi, Bristol-Myers Squibb, and Daiichi Sankyo during the conduct of this study; received grants from Chugai, Kyowa Kirin, and AbbVie, outside the submitted work. KS , C-KM , KK , J-JL , P-SK , S-YH , BD , MK , and S-SL have nothing to report. Funding Information: We thank the patients who participated in the CANDOR trial and the staff at the trial sites who cared for them. Medical writing support, in accordance with the GPP3 guidelines, was provided by Swapnil Kher, PhD, of Cactus Life Sciences (part of Cactus Communications) and was funded by Amgen Inc. Publisher Copyright: © 2021, Japanese Society of Hematology.

PY - 2021/12

Y1 - 2021/12

N2 - Background: Due to increasing use of frontline lenalidomide, effective and safe lenalidomide-free therapies for relapsed/refractory multiple myeloma (RRMM) are needed in Asia. This subgroup analysis of phase 3 CANDOR study evaluated efficacy and safety of KdD vs Kd in Asian patients with RRMM. Methods: Self-identified Asian patients with RRMM (KdD = 46; Kd = 20) with 1‒3 prior therapies were included. The primary endpoint of progression-free survival was estimated by stratified Cox regression. Results: Baseline demographics and patient characteristics were balanced in both arms. KdD reduced the risk of progression or death by 25% vs Kd [hazard ratio (HR) = 0.75; 95% CI 0.259, 2.168] in the Asian subgroup, compared with 37% vs Kd (0.63; 0.464, 0.854) in the overall CANDOR population. Percentage of patients who reported grade ≥ 3 treatment-emergent adverse events (TEAEs) in the KdD and Kd arms was 95.7 and 90.0%, respectively. Serious AEs were observed in 58.7 and 40.0% of patients in the KdD and Kd arms, respectively. There were two (4.3%) fatal TEAEs in the KdD arm due to infections. Conclusions: There was a trend toward better efficacy and a favorable benefit-risk profile for KdD vs Kd in Asian patients with RRMM. Cautious interpretation is warranted due to small patient size.

AB - Background: Due to increasing use of frontline lenalidomide, effective and safe lenalidomide-free therapies for relapsed/refractory multiple myeloma (RRMM) are needed in Asia. This subgroup analysis of phase 3 CANDOR study evaluated efficacy and safety of KdD vs Kd in Asian patients with RRMM. Methods: Self-identified Asian patients with RRMM (KdD = 46; Kd = 20) with 1‒3 prior therapies were included. The primary endpoint of progression-free survival was estimated by stratified Cox regression. Results: Baseline demographics and patient characteristics were balanced in both arms. KdD reduced the risk of progression or death by 25% vs Kd [hazard ratio (HR) = 0.75; 95% CI 0.259, 2.168] in the Asian subgroup, compared with 37% vs Kd (0.63; 0.464, 0.854) in the overall CANDOR population. Percentage of patients who reported grade ≥ 3 treatment-emergent adverse events (TEAEs) in the KdD and Kd arms was 95.7 and 90.0%, respectively. Serious AEs were observed in 58.7 and 40.0% of patients in the KdD and Kd arms, respectively. There were two (4.3%) fatal TEAEs in the KdD arm due to infections. Conclusions: There was a trend toward better efficacy and a favorable benefit-risk profile for KdD vs Kd in Asian patients with RRMM. Cautious interpretation is warranted due to small patient size.

KW - Asian population

KW - CANDOR trial

KW - Carfilzomib

KW - Daratumumab

KW - Relapsed refractory multiple myeloma

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U2 - 10.1007/s12185-021-03204-9

DO - 10.1007/s12185-021-03204-9

M3 - Article

C2 - 34410635

AN - SCOPUS:85113141033

SN - 0925-5710

VL - 114

SP - 653

EP - 663

JO - International Journal of Hematology

JF - International Journal of Hematology

IS - 6

ER -

Carfilzomib, dexamethasone, and daratumumab in Asian patients with relapsed or refractory multiple myeloma: post hoc subgroup analysis of the phase 3 CANDOR trial

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Keywords

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