ASH Clinical News FINAL_ACN_3.14_FULL_ISSUE_DIGITAL | Page 86

On Location ASH 2017 Inside Look
Insights from Scientific Program Co-Chairs
Andrew Weyrich, PhD
Professor of Internal
Medicine
Adjunct Professor of
Pathology
University of Utah School
of Medicine
Salt Lake City, UT
Dr. Weyrich: For this year’s scientific
program, we’ve added a Special Scientific
Symposium on “Hot Topics in Hematology”
that highlights late-breaking, high-impact
stories in hematopoiesis, thrombosis, and
cardiovascular disease. This session features
cutting-edge science with significant
clinical implications and is sure to be a
standing-room-only event.
Which areas of research do you think
will have the most exciting implica-
tions for clinical practice?
Dr. Weyrich: The late-breaking abstracts
always deliver exciting news, and shouldn’t
be missed. This year’s Ernest Beutler Lecture
and Prize, to be delivered by Luigi Naldini,
MD, PhD, and Marina Cavazzana, MD,
PhD, will focus on how HIV has been
exploited to generate efficient and safe
vectors used for the treatment of acquired
Scott Armstrong,
MD, PhD
Chairman,
Department of
Pediatric Oncology,
Dana-Farber Cancer
Institute
Boston, MA
How does this year’s Scientific
Program differ from previous years?
Dr. Armstrong: In designing this
year’s program we had two specific
goals: feature basic-science presen-
tations that have practice-changing
implications and include sessions
with themes and speakers whose
work cuts across malignant and
non-malignant hematology.
Dr. Armstrong: We are witnessing
ongoing discovery in clonal
hematopoiesis in regards to how
the clinical entity CHIP (clonal
For CLL patients with
17p deletion who
have received at least
one prior therapy...
AIM
What are this year’s “can’t-miss”
events?
Dr. Weyrich: This year’s Scientific
Spotlight Sessions (focusing on
analyses of complex sequencing
data in acquired and inherited
hematologic diseases and the
impact of the microbiome on the
hematologic system) will deliver
cutting-edge, clinically relevant
information that will resonate with
a broad audience.
ASH’s scientific committees
have been working all year to
develop outstanding scientific
sessions that feature presentations
from internationally-recognized
experts in benign and malignant
hematology. These sessions will
reveal new discoveries relevant to
hematology researchers.
Dr. Armstrong: There are three
sessions that I think will be of
particular interest to attendees: the
Ad Hoc Scientific Committee on
Epigenetics and Genomics discuss-
ing “Novel Epigenetic Modifica-
tions in Cancer and Development,”
the Joint Session of the Scientific
Committee on Myeloid Biology &
Scientific Committee on Myeloid
Neoplasia discussing “Clonal Evolu-
tion in Myeloid Malignancies,” and
the Special Scientific Symposia on
“Understanding and Modulating the
DNA Damage Response.”
blood diseases – a fascinating topic.
Attendees will learn about the histori-
cal development of hematopoietic stem
cell (HSC) gene therapy and the present
clinical applications and benefits of HSC
gene transfer by lentiviral vectors.
Indication and Important Safety Information
Indication
• VENCLEXTA is indicated for the treatment of patients with chronic
lymphocytic leukemia (CLL) with 17p deletion, as detected by an
FDA-approved test, who have received at least one prior therapy. a
• This indication is approved under accelerated approval based on
overall response rate. Continued approval for this indication may be
contingent upon verification and description of clinical benefit in a
confirmatory trial.
Important Safety Information
Contraindication
• Concomitant use of VENCLEXTA with strong CYP3A inhibitors at
initiation and during ramp-up phase is contraindicated.
Tumor Lysis Syndrome
• Tumor lysis syndrome (TLS), including fatal events and renal failure
requiring dialysis, has occurred in previously treated CLL patients with
high tumor burden treated with VENCLEXTA.
• VENCLEXTA poses a risk for TLS in the initial 5-week ramp-up phase.
Changes in blood chemistries consistent with TLS that require prompt
management can occur as early as 6 to 8 hours following the first
dose of VENCLEXTA and at each dose increase.
• Patients should be assessed for TLS risk, including evaluation of
tumor burden and comorbidities, and should receive appropriate
prophylaxis for TLS, including hydration and anti-
hyperuricemics. Reduced renal function (CrCl <80 mL/min)
further increases the risk. Monitor blood chemistries and
manage abnormalities promptly. Interrupt dosing if needed.
Employ more intensive measures (IV hydration, frequent
monitoring, hospitalization) as overall risk increases.
• Concomitant use of VENCLEXTA with strong or moderate
CYP3A inhibitors and P-gp inhibitors may increase the risk of
TLS at initiation and during the ramp-up phase, and may require
dose adjustment due to increases in VENCLEXTA exposure.
Neutropenia
• Grade 3 or 4 neutropenia occurred in 41% (98/240) of patients
treated with VENCLEXTA. Monitor complete blood counts
throughout treatment. Interrupt dosing or reduce dose for
severe neutropenia. Consider supportive measures including
antimicrobials for signs of infection and use of growth factors
(e.g., G-CSF).
Immunization
• Do not administer live attenuated vaccines prior to, during, or
after treatment with VENCLEXTA until B-cell recovery. Advise
patients that vaccinations may be less effective.
Embryo-Fetal Toxicity
• VENCLEXTA may cause embryo-fetal harm when administered
VENCLEXTA™ is a trademark of AbbVie, Inc.
Distributed and marketed by AbbVie, Inc., 1 North Waukegan Road, North Chicago, IL 60064
Marketed by Genentech USA, Inc., 1 DNA Way, South San Francisco, CA 94080-4990
©2016 AbbVie, Inc. and Genentech USA, Inc.
750-1839967/July 2016
Printed in USA
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ASH Clinical News