DARZALEX ® + Vd signi�cantly improved PFS vs Vd alone 1
DARZALEX ® + Vd signi�cantly improved PFS vs Vd alone 1
100
80
61
%
PFS (%)
60
40
20
DARZALEX ® + Vd Vd
P < 0.0001 HR = 0.39 ( 95 % CI : 0.28 , 0.53 )
0 0 3 6 9 12 15
Months reduction in the risk of disease progression or death with DARZALEX ® + Vd
CASTOR was an open-label , randomized , active-controlled phase 3 trial comparing treatment with DARZALEX ® 16 mg / kg + Vd ( n = 251 ) to Vd alone ( n = 247 ) in multiple myeloma patients who received a minimum of 1 prior therapy . Patients receiving DARZALEX ® were treated with pre- and post-infusion medications . DARZALEX ® was given until disease progression . Ef� cacy was evaluated by PFS based on International Myeloma Working Group ( IMWG ) criteria . 1 , 2
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 .
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 immuno� xation ( 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 %), in� uenza ( 3 %) and pyrexia ( 3 %).
DRUG INTERACTIONS
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 .
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Please see brief summary of full Prescribing Information on adjacent pages .
For more information , visit www . darzalexhcp . com
References : 1 . DARZALEX ® [ Prescribing Information ]. Horsham , PA : Janssen Biotech , Inc . 2 . Palumbo A , Chanan-Khan A , Weisel K , et al ; the CASTOR Investigators . N Engl J Med . 2016 ; 375 ( 8 ): 754-766 .
In patients who received DARZALEX ® in combination with bortezomib and dexamethasone , the most frequently reported adverse reactions ( incidence ≥20 %) were : thrombocytopenia ( 90 %), neutropenia ( 58 %), peripheral sensory neuropathy ( 47 %), infusion reactions ( 45 %), upper respiratory tract infection ( 44 %), diarrhea ( 32 %), cough ( 27 %), peripheral edema ( 22 %), and dyspnea ( 21 %). The overall incidence of serious adverse reactions was 42 %. Serious adverse reactions were upper respiratory tract infection ( 5 %), diarrhea ( 2 %) and atrial � brillation ( 2 %).
© Janssen Biotech , Inc . 2017 05 / 17 064370-170418