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.
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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
VL - 114
SP - 653
EP - 663
JO - International Journal of Hematology
JF - International Journal of Hematology
SN - 0925-5710
IS - 6
ER -