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