ASH Clinical News ACN_4.13_full issue_Web | Page 43

the analysis for Revised International
Prognostic Scoring System score, type
of MDS, TP53 mutation status, and
conditioning regimen, patients with at
least one persistent mutation were still at
an increased risk of disease progression
(HR=4.48; 95% CI 2.21-9.08; p<0.001)
and had a lower rate of one-year PFS
(HR=2.39; 95% CI 1.40-4.09; p=0.002),
compared with those without persistent
mutations.
“We hope these findings lead to
post-transplant mutation testing being in-
corporated into routine clinical care,” Dr.
Jacoby said, noting that researchers are
working to develop a clinical-grade, gene
panel test capable of detecting lower-level
mutations. “Our goal is to move forward
with a large prospective trial using the
clinical-grade assay to detect mutations at
30 days and 100 days post-transplant, to
determine if providing an intervention in
patients who test positive for a mutation
could prevent or delay relapse.”
The study’s findings are limited by its
single-center design, which may reduce
the generalizability of the results, and
limited patient numbers.
“Incorporation of a gene panel assay
to monitor minimum residual disease will
need to include error-corrected sequenc-
ing that is not standard for most commer-
cially available assays,” Dr. Jacoby added.
“Many clinical assays also do not include
matched normal DNA from a patient, so
the assay would also need to be validated
using tumor-only samples in a cohort.”
The authors reported no conflicts of
interest.
REFERENCE
Duncavage EJ, Jacoby MA, Chang GS, et al. Mutation clearance
after transplantation for myelodysplastic syndrome. N Engl J Med.
2018;379:1028-41.
Jivi ® is a new extended half-life rFVIII
hemophilia A treatment with a unique,
step-wise prophylaxis dosing regimen 1
For hemophilia A patients 12 years and older
The recommended initial regimen is 30-40 IU/kg twice weekly. 1
Based on the bleeding episodes 1 :
— The regimen may be adjusted to 45-60 IU/kg every 5 days.
— A regimen may be further individually adjusted to less or more frequent dosing.
IU, international units; kg, kilograms; rFVIII, recombinant Factor VIII.
To contact your rep and learn more,
visit www.hcp.jivi.com.
Reference: 1. Jivi ® Prescribing Information. Whippany, NJ: Bayer LLC; 2018.
The most frequently (≥5%) reported adverse
reactions in clinical trials in previously treated
patients (PTPs) ≥12 years of age were
headache, cough, nausea, and fever.
For additional important risk and use
information, please see the Brief Summary
on the following pages.
You are encouraged to report side effects or quality
complaints of prescription drugs to the FDA. Visit
www.fda.gov/medwatch or call 1-800-FDA-1088.
In case of clinical suspicion of loss of drug
effect, conduct testing for Factor VIII inhibitors
and Factor VIII recovery. A low post-infusion
Factor VIII level in the absence of detectable
Bayer, the Bayer Cross, and Jivi are registered trademarks of Bayer.
© 2018 Bayer. All rights reserved. Printed in USA 09/18 PP-875-US-0234
A clinical immune response associated with IgM
anti-PEG antibodies, manifested as symptoms
of acute hypersensitivity and/or loss of drug
effect, has been observed primarily in patients
< 6 years of age. The symptoms of the clinical
immune response were transient. Anti-PEG
IgM titers decreased over time to undetectable
levels. No immunoglobulin class switching
was observed.
Factor VIII inhibitors indicates that loss of
drug effect is likely due to anti-PEG antibodies.
Discontinue Jivi and switch patients to a
previously effective Factor VIII product.
Neutralizing antibody (inhibitor) formation can
occur following administration of Jivi. Carefully
monitor patients for the development of
Factor VIII inhibitors, using appropriate clinical
observations and laboratory tests. If expected
plasma Factor VIII activity levels are not attained
or if bleeding is not controlled as expected with
administered dose, suspect the presence of an
inhibitor (neutralizing antibody).
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IMPORTANT SAFETY INFORMATION (CONT’D)