Daratumumab plus bortezomib and dexamethasone versus bortezomib and dexamethasone in relapsed or refractory multiple myeloma: updated analysis of CASTOR
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Daratumumab plus bortezomib and dexamethasone versus bortezomib and dexamethasone in relapsed or refractory multiple myeloma: updated analysis of CASTOR. / Spencer, Andrew; Lentzsch, Suzanne; Weisel, Katja; Avet-Loiseau, Hervé; Mark, Tomer M; Spicka, Ivan; Masszi, Tamas; Lauri, Birgitta; Levin, Mark-David; Bosi, Alberto; Hungria, Vania; Cavo, Michele; Lee, Je-Jung; Nooka, Ajay K; Quach, Hang; Lee, Cindy; Barreto, Wolney; Corradini, Paolo; Min, Chang-Ki; Scott, Emma C; Chanan-Khan, Asher A; Horvath, Noemi; Capra, Marcelo; Beksac, Meral; Ovilla, Roberto; Jo, Jae-Cheol; Shin, Ho-Jin; Sonneveld, Pieter; Soong, David; Casneuf, Tineke; Chiu, Christopher; Amin, Himal; Qi, Ming; Thiyagarajah, Piruntha; Sasser, A Kate; Schecter, Jordan M; Mateos, Maria-Victoria.
In: HAEMATOLOGICA, Vol. 103, No. 12, 12.2018, p. 2079-2087.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - Daratumumab plus bortezomib and dexamethasone versus bortezomib and dexamethasone in relapsed or refractory multiple myeloma: 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 - 2018/12
Y1 - 2018/12
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: 0-27.7) 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% con fidence 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: 02136134.
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: 0-27.7) 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% con fidence 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: 02136134.
KW - Journal Article
U2 - 10.3324/haematol.2018.194118
DO - 10.3324/haematol.2018.194118
M3 - SCORING: Journal article
C2 - 30237264
VL - 103
SP - 2079
EP - 2087
JO - HAEMATOLOGICA
JF - HAEMATOLOGICA
SN - 0390-6078
IS - 12
ER -
