TY - JOUR
T1 - Daratumumab plus bortezomib and dexamethasone versus bortezomib and dexamethasone in relapsed or refractory multiple myeloma
T2 - updated analysis of CASTOR
AU - Spencer, Andrew
AU - Lentzsch, Suzanne
AU - Weisel, Katja
AU - Avet-Loiseau, Hervé
AU - Mark, Tomer M
AU - Spicka, Ivan
AU - Masszi, Tamas
AU - Lauri, Birgitta
AU - Levin, Mark-David
AU - Bosi, Alberto
AU - Hungria, Vania
AU - Cavo, Michele
AU - Lee, Je-Jung
AU - Nooka, Ajay K
AU - Quach, Hang
AU - Lee, Cindy
AU - Barreto, Wolney
AU - Corradini, Paolo
AU - Min, Chang-Ki
AU - Scott, Emma C
AU - Chanan-Khan, Asher A
AU - Horvath, Noemi
AU - Capra, Marcelo
AU - Beksac, Meral
AU - Ovilla, Roberto
AU - Jo, Jae-Cheol
AU - Shin, Ho-Jin
AU - Sonneveld, Pieter
AU - Soong, David
AU - Casneuf, Tineke
AU - Chiu, Christopher
AU - Amin, Himal
AU - Qi, Ming
AU - Thiyagarajah, Piruntha
AU - Sasser, A Kate
AU - Schecter, Jordan M
AU - Mateos, Maria-Victoria
N1 - Copyright © 2018, Ferrata Storti Foundation.
PY - 2018/9/20
Y1 - 2018/9/20
N2 - Daratumumab, a CD38 human monoclonal antibody, demonstrated significant clinical activity in combination with bortezomib and dexamethasone versus bortezomib and dexamethasone alone in the primary analysis of CASTOR, a phase 3 study in relapsed and/or refractory multiple myeloma. A post hoc analysis based on treatment history and longer follow-up is presented. After 19.4 (range: 0 to 27.7) months of median follow-up, daratumumab plus bortezomib and dexamethasone prolonged progression-free survival (median: 16.7 versus 7.1 months; hazard ratio, 0.31; 95% confidence interval, 0.24-0.39; P <0.0001) and improved the overall response rate (83.8% versus 63.2%; P <0.0001) compared with bortezomib and dexamethasone alone. The progression-free survival benefit of daratumumab plus bortezomib and dexamethasone was most apparent in patients with 1 prior line of therapy (median: not reached versus 7.9 months; hazard ratio, 0.19; 95% confidence interval, 0.12-0.29; P <0.0001). Daratumumab plus bortezomib and dexamethasone was also superior to bortezomib and dexamethasone alone in subgroups based on prior treatment exposure (bortezomib, thalidomide, or lenalidomide), lenalidomide-refractory status, time since last therapy (≤12, >12, ≤6, or >6 months), or cytogenetic risk. Minimal residual disease-negative rates were >2.5-fold higher with daratumumab across subgroups. The safety profile of daratumumab plus bortezomib and dexamethasone remained consistent with longer follow-up. Daratumumab plus bortezomib and dexamethasone demonstrated significant clinical activity across clinically relevant subgroups and provided the greatest benefit to patients treated at first relapse.TRIAL REGISTRATION: clinicaltrials.gov identifier: NCT02136134.
AB - Daratumumab, a CD38 human monoclonal antibody, demonstrated significant clinical activity in combination with bortezomib and dexamethasone versus bortezomib and dexamethasone alone in the primary analysis of CASTOR, a phase 3 study in relapsed and/or refractory multiple myeloma. A post hoc analysis based on treatment history and longer follow-up is presented. After 19.4 (range: 0 to 27.7) months of median follow-up, daratumumab plus bortezomib and dexamethasone prolonged progression-free survival (median: 16.7 versus 7.1 months; hazard ratio, 0.31; 95% confidence interval, 0.24-0.39; P <0.0001) and improved the overall response rate (83.8% versus 63.2%; P <0.0001) compared with bortezomib and dexamethasone alone. The progression-free survival benefit of daratumumab plus bortezomib and dexamethasone was most apparent in patients with 1 prior line of therapy (median: not reached versus 7.9 months; hazard ratio, 0.19; 95% confidence interval, 0.12-0.29; P <0.0001). Daratumumab plus bortezomib and dexamethasone was also superior to bortezomib and dexamethasone alone in subgroups based on prior treatment exposure (bortezomib, thalidomide, or lenalidomide), lenalidomide-refractory status, time since last therapy (≤12, >12, ≤6, or >6 months), or cytogenetic risk. Minimal residual disease-negative rates were >2.5-fold higher with daratumumab across subgroups. The safety profile of daratumumab plus bortezomib and dexamethasone remained consistent with longer follow-up. Daratumumab plus bortezomib and dexamethasone demonstrated significant clinical activity across clinically relevant subgroups and provided the greatest benefit to patients treated at first relapse.TRIAL REGISTRATION: clinicaltrials.gov identifier: NCT02136134.
U2 - 10.3324/haematol.2018.194118
DO - 10.3324/haematol.2018.194118
M3 - Article
C2 - 30237264
JO - Haematologica
JF - Haematologica
SN - 0390-6078
ER -