Verastem, Inc. (Nasdaq:VSTM) (Verastem Oncology or the Company),
a biopharmaceutical company focused on developing and
commercializing medicines seeking to improve the survival and
quality of life of cancer patients, today announced that five
posters highlighting clinical data for COPIKTRA™ (duvelisib) will
be presented at the Lymphoma & Myeloma 2019 International
Congress taking place October 23-26, 2019, in New York City. The
presented abstracts focus on clinical data from the Phase 3 DUO
study, including evaluation of COPIKTRA efficacy and safety in
high-risk patients with relapsed or refractory chronic lymphocytic
leukemia/small lymphocytic lymphoma (CLL/SLL), dose modification
data and results from a post-hoc analysis evaluating the effect of
COPIKTRA on lymphocytosis in patients. Other presented data include
the characterization of duvelisib in patients with refractory
Marginal Zone Lymphoma from the Phase 2 DYNAMO study, and an update
on the safety profile and management of adverse events in heavily
pre-treated patients with advanced hematological malignancies.
“Findings from the DUO study demonstrated that patients taking
duvelisib who have received two or more prior therapies experienced
improved clinical outcomes and a manageable safety profile,” states
Matthew S. Davids, MD, Associate Director, Center for Chronic
Lymphocytic Leukemia at Dana-Farber Cancer Institute. “These
results with duvelisib are important for this patient population,
which is in need of targeted therapies to control their
disease.”
“The data presented at this year’s Lymphoma & Myeloma
Congress reflect the utility of duvelisib in patients with relapsed
or refractory CLL/SLL after at least two prior therapies, including
in patients with advanced disease or at high-risk of recurrence,”
commented Hagop Youssoufian, MSc, M.D., Head of Medical Strategy at
Verastem Oncology. “Further, the research supports the approach to
management of adverse events through dose interruptions or dose
reductions without an impact on the patient’s response, which could
allow patients who are benefitting to stay on therapy longer.”
COPIKTRA, a targeted oral inhibitor of phosphoinositide 3-kinase
(PI3K), and the first approved dual inhibitor of PI3K-delta and
PI3K-gamma, received approval as monotherapy from the U.S. Food and
Drug Administration (FDA) in September 2018 for the treatment of
patients with relapsed or refractory CLL/SLL after at least two
prior therapies. COPIKTRA also received accelerated approval for
the treatment of adult patients with relapsed or refractory
follicular lymphoma (FL) after at least two prior systemic
therapies. Continued approval in FL may be contingent upon
verification and description of clinical benefit in confirmatory
trials.
Details for the poster presentations are as follows:
Title: An improved benefit-risk profile of duvelisib in
patients with chronic lymphocytic leukemia or small lymphocytic
lymphoma who received ≥2 prior therapies Lead author: Matt
Davids, M.D., Dana-Farber Cancer Institute, Boston, MA
Presentation ID: P-012
Title: Effect of dose modifications on response to
duvelisib in patients with relapsed or refractory CLL/SLL in the
DUO trial Lead author: Nicole Lamanna, Columbia University
Medical Center Presentation ID: P-030
Title: Patterns of duvelisib-induced lymphocytosis in
patients with relapsed/refractory chronic lymphocytic
leukemia/small lymphocytic lymphoma, including those with high-risk
factors treated in the DUO trial Lead author: Jacqueline
Barrientos, Zucker School of Medicine at Hofstra/Northwell
Presentation ID: P-015
Title: Characterization of duvelisib in patients with
refractory marginal zone lymphoma: data from the phase 2 DYNAMO
trial Lead author: Eric Jacobsen, Dana-Farber Cancer
Institute, Boston, MA Presentation ID: P-029
Title: Safety Profile and Management of Adverse Events
Associated with Duvelisib in Patients with Advanced Hematologic
Malignancies Lead author: Karen Francoeur, Verastem Oncology
Presentation ID: P-031
PDF copies of these poster presentations will be available
here after the meeting.
COPIKTRA includes a Boxed Warning for fatal and serious
toxicities including infections, diarrhea or colitis, cutaneous
reactions and pneumonitis. See full Prescribing Information for
complete Boxed Warning and other important safety information.
SELECT IMPORTANT SAFETY INFORMATION
This does not include all information needed to use COPIKTRA™
(duvelisib) safely and effectively. See full Prescribing
Information.
WARNING: FATAL AND SERIOUS TOXICITIES: INFECTIONS, DIARRHEA OR
COLITIS, CUTANEOUS REACTIONS, and PNEUMONITIS See full
Prescribing Information for complete boxed warning
- Fatal and/or serious infections occurred in 31% (4% fatal) of
COPIKTRA-treated patients. Monitor for signs and symptoms of
infection. Withhold COPIKTRA if infection is suspected.
- Fatal and/or serious diarrhea or colitis occurred in 18%
(<1% fatal) of COPIKTRA-treated patients. Monitor for the
development of severe diarrhea or colitis. Withhold COPIKTRA.
- Fatal and/or serious cutaneous reactions occurred in 5% (<1%
fatal) of COPIKTRA-treated patients. Withhold COPIKTRA.
- Fatal and/or serious pneumonitis occurred in 5% (<1% fatal)
of COPIKTRA-treated patients. Monitor for pulmonary symptoms and
interstitial infiltrates. Withhold COPIKTRA.
INDICATIONS AND USAGE
COPIKTRA is a kinase inhibitor indicated for the treatment of
adult patients with:
- Relapsed or refractory chronic lymphocytic leukemia (CLL) or
small lymphocytic lymphoma (SLL) after at least two prior
therapies.
- Relapsed or refractory follicular lymphoma (FL) after at least
two prior systemic therapies. Accelerated approval based on overall
response rate and continued approval may be contingent upon
confirmatory trials
WARNINGS AND PRECAUTIONS
- Hepatotoxicity: Monitor hepatic function.
- Neutropenia: Monitor blood counts.
- Embryo-Fetal toxicity: COPIKTRA can cause fetal harm. Advise
patients of potential risk to a fetus and to use effective
contraception.
ADVERSE REACTIONS
The most common adverse reactions (≥20%) are diarrhea or
colitis, neutropenia, rash, fatigue, pyrexia, cough, nausea, upper
respiratory infection, pneumonia, musculoskeletal pain, and
anemia.
To report Adverse Reactions, contact FDA at 1-800-FDA-1088
(1-800-332-1088) or www.fda.gov/medwatch and Verastem Oncology at
1-877-7RXVSTM (1-877-779-8786).
DRUG INTERACTIONS
- CYP3A inducers: Avoid co-administration with strong CYP3A
inducers.
- CYP3A inhibitors: Monitor for COPIKTRA toxicities when
co-administered with strong or moderate CYP3A inhibitors. Reduce
COPIKTRA dose to 15 mg twice daily when co-administered with strong
CYP3A4 inhibitors.
- CYP3A substrates: Monitor for signs of toxicities when
co-administering COPIKTRA with sensitive CYP3A substrates.
USE IN SPECIFIC POPULATIONS
Lactation: Advise women not to breastfeed.
About COPIKTRA™ (duvelisib)
COPIKTRA is an oral inhibitor of phosphoinositide 3-kinase
(PI3K), and the first approved dual inhibitor of PI3K-delta and
PI3K-gamma, two enzymes known to help support the growth and
survival of malignant B-cells. PI3K signaling may lead to the
proliferation of malignant B-cells and is thought to play a role in
the formation and maintenance of the supportive tumor
microenvironment.1,2,3 COPIKTRA is indicated for the treatment of
adult patients with relapsed or refractory chronic lymphocytic
leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two
prior therapies and relapsed or refractory follicular lymphoma (FL)
after at least two prior systemic therapies. COPIKTRA is also being
developed by Verastem Oncology for the treatment of peripheral
T-cell lymphoma (PTCL), for which it has received Fast Track status
and Orphan Drug Designation, and is being investigated in
combination with other agents through investigator-sponsored
studies.4 For more information on COPIKTRA, please visit
www.COPIKTRA.com. Information about duvelisib clinical trials can
be found on www.clinicaltrials.gov.
About Verastem Oncology
Verastem Oncology (Nasdaq: VSTM) is a commercial
biopharmaceutical company committed to the development and
commercialization of medicines to improve the lives of patients
diagnosed with cancer. We are driven by the strength, tenacity and
courage of those battling cancer – single-minded in our resolve to
deliver new therapies that not only keep cancer at bay, but improve
the lives of patients diagnosed with cancer. Because for us, it’s
personal.
Our first FDA approved product is now available for the
treatment of patients with certain types of indolent non-Hodgkin’s
lymphoma (iNHL). Our pipeline comprises product candidates that
seek to treat cancer by modulating the local tumor
microenvironment. For more information, please visit
www.verastem.com.
Forward looking statements notice
This press release includes forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
that are subject to risks, uncertainties and other factors,
including those related to the safety and efficacy of COPIKTRA; the
uncertainties inherent in research and development of COPIKTRA,
such as negative or unexpected results of clinical trials; that
enrollment of clinical trials may take longer than expected; and
that COPIKTRA or our other product candidates will cause unexpected
safety events, experience manufacturing or supply interruptions or
failures, or result in unmanageable safety profiles as compared to
their levels of efficacy. These risks, uncertainties and other
factors could cause actual results to differ materially from those
referred to in the forward-looking statements. The reader is
cautioned not to rely on these forward-looking statements.
Other risks and uncertainties include those identified under the
heading “Risk Factors” in the Company’s Quarterly Report on Form
10-Q for the quarterly period ended June 30, 2019, as filed with
the Securities and Exchange Commission (SEC) on August 1, 2019, its
Annual Report on Form 10-K for the year ended December 31, 2018 as
filed with the SEC on March 12, 2019 and in any subsequent filings
with the SEC. The forward-looking statements contained in this
press release reflect Verastem Oncology’s views as of the date
hereof, and the Company does not assume and specifically disclaims
any obligation to update any forward-looking statements whether as
a result of new information, future events or otherwise, except as
required by law.
References
1 Winkler D.G., Faia K.L., DiNitto J.P. et al. PI3K-delta and
PI3K-gamma inhibition by IPI-145 abrogates immune responses and
suppresses activity in autoimmune and inflammatory disease models.
Chem Biol 2013; 20:1-11. 2 Reif K et al. Cutting Edge: Differential
Roles for Phosphoinositide 3 kinases, p110-gamma and p110-delta, in
lymphocyte chemotaxis and homing. J Immunol 2004:173:2236-2240. 3
Schmid M et al. Receptor Tyrosine Kinases and TLR/IL1Rs
Unexpectedly activate myeloid cell PI3K, a single convergent point
promoting tumor inflammation and progression. Cancer Cell
2011;19:715-727. 4 www.clinicaltrials.gov, NCT03372057.
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version on businesswire.com: https://www.businesswire.com/news/home/20191023005246/en/
Investors: John Doyle Vice President, Investor Relations &
Finance +1 781-469-1546 jdoyle@verastem.com Media: Lisa Buffington
Corporate Communications +1 781-292-4205
lbuffington@verastem.com
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