Daratumumab plus bortezomib and dexamethasone versus bortezomib and dexamethasone in relapsed or refractory multiple myeloma: updated analysis of CASTOR

Andrew Spencer, Suzanne Lentzsch, Katja Weisel, Hervé Avet-Loiseau, Tomer M Mark, Ivan Spicka, Tamas Masszi, Birgitta Lauri, Mark-David Levin, Alberto Bosi, Vania Hungria, Michele Cavo, Je-Jung Lee, Ajay K Nooka, Hang Quach, Cindy Lee, Wolney Barreto, Paolo Corradini, Chang-Ki Min, Emma C Scott, Asher A Chanan-Khan, Noemi Horvath, Marcelo Capra, Meral Beksac, Roberto Ovilla, Jae-Cheol Jo, Ho-Jin Shin, Pieter Sonneveld, David Soong, Tineke Casneuf, Christopher Chiu, Himal Amin, Ming Qi, Piruntha Thiyagarajah, A Kate Sasser, Jordan M Schecter, Maria-Victoria Mateos
Haematologica 2018, 103 (12): 2079-2087
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: identifier: 02136134 .

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