ASH Clinical News July 2017 V2 - Page 13

DARZALEX ® + Vd significantly improved PFS vs Vd alone 1 100 61 % 80 60 61 40 DARZALEX ® + Vd Vd 20 P<0.0001 HR=0.39 (95% CI: 0.28, 0.53) 0 0 3 6 9 12 15 reduction in the risk of disease progression or death with DARZALEX ® + Vd % CASTOR was an open-label, randomized, active-controlled phase 3 trial comparing with DARZALEX ® 16 mg/kg + Vd reduction treatment in the (n=251) to Vd alone (n=247) in multiple risk of disease myeloma patients who received a minimum of progression or death with 1 prior therapy. Patients receiving DARZALEX ® ® + Vd DARZALEX were treated with pre- and post-infusion medications. DARZALEX ® was given until disease progression. Efficacy was evaluated by PFS based on International Myeloma Working Group (IMWG) criteria. 1,2 Months 79.3 % ORR with DARZALEX ® + Vd vs 59.9% with Vd alone (P<0.0001). CR or better was 18.3% with DARZALEX ® + Vd vs 8.5% with Vd alone. VGPR was 38.2% vs 19.0%, and PR was 22.7% vs 32.4% with DARZALEX ® + Vd vs Vd alone, respectively. 1 Vd=bortezomib and dexamethasone. DRUG INTERACTIONS Important Safety Information (cont’d) Interference with Determination of Complete Response Daratumumab is a human IgG kappa monoclonal antibody that can be detected on both the serum protein electrophoresis (SPE) and immunofixation (IFE) assays used for the clinical monitoring of endogenous M-protein. This interference can impact the determination of complete response and of disease progression in some patients with IgG kappa myeloma protein. Adverse Reactions In patients who received DARZALEX ® in combination with lenalidomide and dexamethasone, the most frequently reported adverse reactions (incidence ≥20%) were: neutropenia (92%), thrombocytopenia (73%), upper respiratory tract infection (65%), infusion reactions (48%), diarrhea (43%), fatigue (35%), cough (30%), muscle spasms (26%), nausea (24%), dyspnea (21%) and pyrexia (20%). The overall incidence of serious adverse reactions was 49%. Serious adverse reactions were pneumonia (12%), upper respiratory tract infection (7%), influenza (3%) and pyrexia (3%). Effect of Other Drugs on Daratumumab: The coadministration of lenalidomide or bortezomib with DARZALEX ® did not affect the pharmacokinetics of daratumumab. Effect of Daratumumab on Other Drugs: The coadministration of DARZALEX ® with bortezomib did not affect the pharmacokinetics of bortezomib. 06348