DARZALEX ® responses were demonstrated in patients with a median of 5 prior therapies 1 *
overall response rate 1 ( 95 % CI : 20.8 , 38.9 )
Important Safety Information
DARZALEX ® responses were demonstrated in patients with a median of 5 prior therapies 1 *
%
overall response rate 1 ( 95 % CI : 20.8 , 38.9 )
• DARZALEX ® achieved sCR + VGPR in 12 % of patients 1
• Duration of response range : 1.2 to 13.1 + months 1
PR = partial response ; VGPR = very good partial response ; sCR = stringent complete response .
* For this open-label single-arm phase 2 trial of 106 relapsed / refractory patients who were administered pre- and post-infusion medications and treated with 16 mg / kg DARZALEX ® until unacceptable toxicity or disease progression , ef� cacy results were based on ORR as determined by an Independent Review Committee assessment using International Myeloma Working Group ( IMWG ) criteria . 1 , 2
†
In the trial , sCR was de�ned as complete response ( CR ) plus a normal serum free light chain ( FLC ) ratio and the absence of clonal plasma cells in the bone marrow by immunohistochemistry or immuno�uorescence or 2- to 4-color �ow cytometry . 3
• The most frequently reported adverse reactions ( ≥20 %) were infusion reactions ( 48 %), fatigue ( 39 %), nausea ( 27 %), back pain ( 23 %), pyrexia ( 21 %), cough ( 21 %), and upper respiratory tract infection ( 20 %) 1 ‡
— Serious adverse reactions were reported in 51 ( 33 %) patients . The most frequent serious adverse reactions were pneumonia ( 6 %), general physical health deterioration ( 3 %), and pyrexia ( 3 %) 1
• 4 % of patients discontinued treatment due to adverse reactions ( ARs ); ARs resulted in treatment delay for 24 patients ( 15 %), most frequently for infections 1
‡
Safety data were pooled from 3 open-label clinical studies of relapsed / refractory patients treated with 16 mg / kg DARZALEX ® ( N = 156 ). 1
Important Safety Information
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
The most frequently reported adverse reactions ( incidence ≥20 %) were : infusion reactions ( 48 %), fatigue ( 39 %), nausea ( 27 %), back pain ( 23 %), pyrexia ( 21 %), cough ( 21 %), and upper respiratory tract infection ( 20 %).
Serious adverse reactions were reported in 51 ( 33 %) patients . The most frequent serious adverse reactions were pneumonia ( 6 %), general physical health deterioration ( 3 %), and pyrexia ( 3 %).
DRUG INTERACTIONS
References : 1 . DARZALEX ® [ Prescribing Information ]. Horsham , PA : Janssen Biotech , Inc . 2 . Data on � le . Trial Design . Janssen Biotech , Inc . 3 . Data on � le . sCR . Janssen Biotech , Inc .
For more information , visit www . darzalex . com
No drug interaction studies have been performed .
048504-160304
© Janssen Biotech , Inc . 2016 03 / 16 048265-160301