ASH Clinical News FINAL_ACN_3.14_FULL_ISSUE_DIGITAL | Page 63
DARZALEX ® + Vd signi cantly improved PFS vs Vd alone 1
100
61
%
80
reduction in the risk of
disease progression or
death with DARZALEX ® + Vd
60
40
DARZALEX ® + Vd
Vd
20
P<0.0001
HR=0.39 (95% CI: 0.28, 0.53)
0
0
3
6
9
12
15
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
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 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%).
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.
063483-161117
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