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 three
posters highlighting clinical data for COPIKTRA™ (duvelisib) will
be presented at the 18th Annual International Workshop on Chronic
Lymphocytic Leukemia taking place September 20-23, 2019, in
Edinburgh, UK. The presented abstracts focus on clinical data from
the Phase 3 DUO study including evaluation of COPIKTRA efficacy and
safety in heavily pre-treated 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,
including those with high-risk factors.
“Many patients with CLL or SLL eventually relapse and are in
need of additional therapy options to help control their disease,”
said Marco Montillo, M.D., Head, Department of Hematology and
Oncology, Niguarda Cancer Center, Niguarda Hospital, Milan, Italy.
“In the DUO study, duvelisib monotherapy demonstrated significantly
improved clinical outcomes in patients with relapsed refractory
disease who had received two or more prior therapies. In the study,
the safety profile of duvelisib was generally manageable through
dose modifications or interruptions.”
“The data presented at iwCLL this year highlight findings from
the Phase 3 DUO study in the labeled indication of relapsed or
refractory CLL/SLL after at least 2 prior therapies,” commented
Hagop Youssoufian, MSc, M.D., Head of Medical Strategy at Verastem
Oncology. “Of note, response rates appeared to be preserved in
COPIKTRA-treated patients whose adverse events, occurring on
therapy, were effectively managed through dose interruptions or
dose reductions. These findings from the study are an important
factor in helping physicians navigate the management of adverse
events in the clinical setting with the goal of not compromising
efficacy.”
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 iwCLL 2019 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: Marco Montillo,
Niguarda Cancer Center
Presentation ID: 1914
Date and time: Sunday, September
22, 2019; all day
Title: Effect of dose modifications
on response to duvelisib in patients with relapsed or refractory
CLL/SLL in the DUO trial
Lead author: Paolo Ghia, Università
Vita-Salute San Raffaele and IRCCS Ospedale San Raffaele
Presentation ID: 2034
Date and time: Sunday, September
22, 2019; all day
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: 2033
Date and time: Sunday, September
22, 2019; all day
PDF copies of these poster presentations will be available here
after the meeting.
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% 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% of
COPIKTRA-treated patients. Monitor for the development of severe
diarrhea or colitis. Withhold COPIKTRA.
- Fatal and/or serious cutaneous reactions occurred in 5% of
COPIKTRA-treated patients. Withhold COPIKTRA.
- Fatal and/or serious pneumonitis occurred in 5% of
COPIKTRA-treated patients. Monitor for pulmonary symptoms and
interstitial infiltrates. Withhold COPIKTRA.
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.
Please see accompanying full Prescribing Information,
including Boxed Warning.
About Chronic Lymphocytic Leukemia/Small Lymphocytic
Lymphoma
Chronic lymphocytic leukemia (CLL) and small lymphocytic
lymphoma (SLL) are cancers that affect lymphocytes and are
essentially the same disease, with the only difference being the
location where the cancer primarily occurs. When most of the cancer
cells are located in the bloodstream and the bone marrow, the
disease is referred to as CLL, although the lymph nodes and spleen
are often involved. When the cancer cells are located mostly in the
lymph nodes, the disease is called SLL. The symptoms of CLL/SLL
include a tender, swollen abdomen and feeling full even after
eating only a small amount. Other symptoms can include fatigue,
shortness of breath, anemia, bruising easily, night sweats, weight
loss, and frequent infections. However, many patients with CLL/SLL
will live for years without symptoms. There are approximately
200,000 patients in the US affected by CLL/SLL with nearly 20,000
new diagnoses this year alone. While there are therapies currently
available, real-world data reveals that a significant number of
patients either relapse following treatment, become refractory to
current agents, or are unable to tolerate treatment, representing a
significant medical need. The potential of additional oral agents,
particularly as a monotherapy that can be used in the general
community physician’s armamentarium, may hold significant value in
the treatment of patients with CLL/SLL.
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 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 about
Verastem Oncology’s strategy, future plans and prospects, and
financial results. The words "anticipate," "believe," "estimate,"
"expect," "intend," "may," "plan," "predict," "project," "target,"
"potential," "will," "would," "could," "should," "continue," and
similar expressions are intended to identify forward-looking
statements, although not all forward-looking statements contain
these identifying words. Each forward-looking statement is subject
to risks and uncertainties that could cause actual results to
differ materially from those expressed or implied in such
statement.
Applicable risks and uncertainties include the risks and
uncertainties, among other things, regarding: the commercial
success of COPIKTRA™ in the United States; physician and patient
adoption of COPIKTRA, 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; whether and when any applications for COPIKTRA may
be filed with regulatory authorities in any other jurisdictions;
whether and when regulatory authorities in any other jurisdictions
may approve any such other applications that may be filed for
COPIKTRA, which will depend on the assessment by such regulatory
authorities of the benefit-risk profile suggested by the totality
of the efficacy and safety information submitted and, if approved,
whether COPIKTRA will be commercially successful in such
jurisdictions; our ability to obtain, maintain and enforce patent
and other intellectual property protection for COPIKTRA and our
other product candidates; the scope, timing, and outcome of any
legal proceedings; decisions by regulatory authorities regarding
labeling and other matters that could affect the availability or
commercial potential of COPIKTRA; the fact that regulatory
authorities in the U.S. or other jurisdictions, if approved, could
withdraw approval; whether preclinical testing of our product
candidates and preliminary or interim data from clinical trials
will be predictive of the results or success of ongoing or later
clinical trials; that the timing, scope and rate of reimbursement
for our product candidates is uncertain; that third-party payors
(including government agencies) may not reimburse for COPIKTRA;
that there may be competitive developments affecting our product
candidates; that data may not be available when expected; that
enrollment of clinical trials may take longer than expected; 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; that COPIKTRA will be ineffective at
treating patients with lymphoid malignancies; that we will be
unable to successfully initiate or complete the clinical
development and eventual commercialization of our product
candidates; that the development and commercialization of our
product candidates will take longer or cost more than planned; that
we may not have sufficient cash to fund our contemplated
operations; that we, CSPC Pharmaceutical Group, Yakult Honsha Co.,
Ltd., Sanofi or Infinity Pharmaceuticals, Inc. will fail to fully
perform under the duvelisib license agreements; that we may be
unable to make additional draws under our debt facility or obtain
adequate financing in the future through product licensing,
co-promotional arrangements, public or private equity, debt
financing or otherwise; that we will not pursue or submit
regulatory filings for our product candidates, including for
duvelisib in patients with chronic lymphocytic leukemia/small
lymphocytic lymphoma (CLL/SLL) or indolent non-Hodgkin lymphoma
(iNHL) in other jurisdictions; and that our product candidates will
not receive regulatory approval, become commercially successful
products, or result in new treatment options being offered to
patients.
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/20190920005019/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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