ASH Clinical News September 2016 | Page 51
DARZALEX® responses were demonstrated in patients with a median of
5 prior therapies1*
%
overall response rate1
(95% CI: 20.8, 38.9)
PR=partial response; VGPR=very good partial
response; sCR=stringent complete response.
• DARZALEX® achieved sCR + VGPR in 12% of patients1
*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, efcacy 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 dened 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 immunouorescence
or 2- to 4-color ow cytometry.3
†
• Duration of response range: 1.2 to 13.1+ months1
• 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 infections1
‡
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 immunoxation (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
No drug interaction studies have been performed.
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
© Janssen Biotech, Inc. 2016
03/16
048265-160301
048504-160304