Four Abstracts Selected, Including Two Oral Presentations
BOSTON--(BUSINESS WIRE)--Nov. 1, 2017--
Verastem, Inc. (NASDAQ: VSTM), focused on discovering and developing
drugs to improve the survival and quality of life of cancer patients,
today announced that four abstracts have been selected for presentation,
including two oral presentations, at the upcoming American Society of
Hematology (ASH) 2017 Annual Meeting being held December 9-12, 2017 in
Atlanta. Included among the oral presentations are the detailed results
from the Phase 3 DUO™ study evaluating the efficacy and safety of
duvelisib, a first-in-class oral dual inhibitor of phosphoinositide
3-kinase (PI3K)-delta and PI3K-gamma, in patients with relapsed or
refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma
(SLL). As previously announced, the DUO study achieved its primary
endpoint with oral duvelisib monotherapy demonstrating superiority over
ofatumumab for progression free survival (PFS) in patients with CLL/SLL.
“Previously reported top-line data from the pivotal Phase 3 DUO study
significantly favored duvelisib monotherapy over ofatumumab, an approved
standard of care treatment for patients with relapsed or refractory
CLL/SLL, achieving a statistically significant improvement in median PFS
and a hazard ratio (HR) of 0.52 (p<0.0001), with a consistent and
manageable safety profile,” said Robert Forrester, President and Chief
Executive Officer of Verastem. “We look forward to sharing the detailed
results from the DUO study with the medical community at ASH this year.”
Verastem recently announced that a meeting was held with the U.S. Food
and Drug Administration (FDA) regarding the regulatory path for
duvelisib. Based on the meeting with, and written feedback from the FDA,
Verastem intends to submit a New Drug Application (NDA) requesting the
full approval of duvelisib for the treatment of patients with relapsed
or refractory CLL/SLL and accelerated approval for the treatment of
patients with relapsed or refractory follicular lymphoma (FL). Along
with the clinical data from the DUO study, the duvelisib NDA submission
will also contain the favorable results from the Phase 2 DYNAMO™ study
in double-refractory indolent non-Hodgkin’s lymphoma (iNHL), which also
achieved its primary endpoint with an ORR of 46% (p<0.0001). In the
subset of patients enrolled in the DYNAMO study with double-refractory
FL (n=83), duvelisib demonstrated an ORR of 41%. The Company expects to
submit the duvelisib NDA during the first quarter of 2018.
Details for the ASH 2017 presentations are as follows:
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Oral Presentations
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Title: Results from the Phase 3 DUOTM Trial: A
Randomized Comparison of Duvelisib Vs Ofatumumab in Patients with
Relapsed/Refractory Chronic Lymphocytic Leukemia or Small
Lymphocytic Lymphoma
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Presenter: Ian Flinn, M.D., Ph.D., Sarah Cannon Research
Institute
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Abstract Number/Publication ID: 493
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Session: 642. CLL: Therapy, excluding Transplantation:
Targeting MRD Negative CLL with Combinations of Novel Agents and
Chemoimmunotherapy Regimens, New Treatments; Sunday, December 10,
2017 from 4:30-6:00 PM ET
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Date and Time: Sunday, December 10, 2017 at 4:30 PM ET
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Location: Georgia World Congress Center, Building B, Level
5, Murphy BR 3-4
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Title: In Vitro, In Vivo, and Parallel Phase I Evidence
Support the Safety and Activity of Duvelisib, a PI3K-δ,γ
Inhibitor, in Combination with Romidepsin or Bortezomib in
Relapsed/Refractory T-Cell Lymphoma
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Presenter: Steven Horwitz, M.D., Memorial Sloan Kettering
Cancer Center
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Abstract Number/Publication ID: 819
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Session: 624. Hodgkin Lymphoma and T/NK Cell
Lymphoma—Clinical Studies: T-Cell Lymphoma Clinical Studies;
Monday, December 11, 2017 from 4:30-6:00 PM ET
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Date and Time: Monday, December 11, 2017 at 5:00 PM ET
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Location: Georgia World Congress Center, Building A, Level
4, Marcus Auditorium
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Poster Presentations
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Title: The Dual PI3K-δ,γ Inhibitor Duvelisib Stimulates
Anti-Tumor Immunity and Enhances Efficacy of Immune Checkpoint and
Co-Stimulatory Antibodies in a B Cell Lymphoma Model
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Presenter: Jonathan Pachter, Ph.D., Verastem
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Abstract Number/Publication ID: 1541
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Session: 625. Lymphoma: Pre-Clinical—Chemotherapy and Biologic
Agents: Poster I
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Date and Time: Saturday, December 9, 2017 from 5:30-7:30 PM
ET
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Location: Georgia World Congress Center, Building A, Level
1, Hall A2
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Title: Combinatorial Inhibition of Focal Adhesion Kinase
and BCL-2 in AML
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Presenter: Xiangmeng Wang, Ph.D., MD Anderson Cancer Center
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Abstract Number/Publication ID: 2653
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Session: 616. Acute Myeloid Leukemia: Novel Therapy,
excluding Transplantation: Poster II
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Date and Time: Sunday, December 10, 2017 from 6:00-8:00 PM
ET
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Location: Georgia World Congress Center, Building A, Level
1, Hall A2
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About Duvelisib
Duvelisib is a first-in-class investigational, dual inhibitor of
phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, two enzymes known
to help support the growth and survival of malignant B-cells and
T-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 Duvelisib is
currently being evaluated in late- and mid-stage extension trials,
including DUO™, a randomized, Phase 3 monotherapy study in patients with
relapsed or refractory chronic lymphocytic leukemia (CLL)/small
lymphocytic lymphoma (SLL),4 and DYNAMO™, a single-arm, Phase
2 monotherapy study in patients with refractory indolent non-Hodgkin
lymphoma (iNHL).5 Both DUO and DYNAMO achieved their primary
endpoints and Verastem intends to submit a New Drug Application (NDA)
requesting the full approval of duvelisib for the treatment of patients
with relapsed or refractory CLL/SLL, and accelerated approval for the
treatment of patients with relapsed or refractory follicular lymphoma
(FL). Duvelisib is also being developed by Verastem for the treatment of
peripheral T-cell lymphoma (PTCL), and is being investigated in
combination with other agents through investigator-sponsored studies.6
Information about duvelisib clinical trials can be found on www.clinicaltrials.gov.
About Verastem, Inc.
Verastem, Inc. (NASDAQ: VSTM) is a biopharmaceutical company focused on
discovering and developing drugs to improve outcomes for patients with
cancer. Verastem is currently developing duvelisib, a dual inhibitor of
PI3K-delta and PI3K-gamma, which has successfully met its primary
endpoint in a Phase 2 study in indolent non-Hodgkin lymphoma (iNHL) and
a Phase 3 clinical trial in patients with chronic lymphocytic leukemia
(CLL)/small lymphocytic lymphoma (SLL). In addition, Verastem is
developing the FAK inhibitor defactinib, which is currently being
evaluated in three separate clinical collaborations in combination with
immunotherapeutic agents for the treatment of several different cancer
types, including pancreatic cancer, ovarian cancer, non-small cell lung
cancer, and mesothelioma. Verastem’s product candidates seek to treat
cancer by modulating the local tumor microenvironment, enhancing
anti-tumor immunity, and reducing cancer stem cells. For more
information, please visit www.verastem.com.
Verastem, Inc. forward-looking statements notice:
This press release includes forward-looking statements about Verastem's
strategy, future plans and prospects, including statements regarding the
development and activity of Verastem's investigational product
candidates, including duvelisib and defactinib, and Verastem's PI3K and
FAK programs generally, the structure of our planned and pending
clinical trials and the timeline and indications for clinical
development and regulatory submissions. 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 that the full data
from the DUO study will not be consistent with the top-line results of
the study; that the preclinical testing of Verastem's product candidates
and preliminary or interim data from clinical trials may not be
predictive of the results or success of ongoing or later clinical
trials; that data may not be available when expected, including for the
Phase 3 DUO™ study; that even if data from clinical trials is positive,
regulatory authorities may require additional studies for approval and
the product may not prove to be safe and effective; that the degree of
market acceptance of product candidates, if approved, may be lower than
expected; that the timing, scope and rate of reimbursement for our
product candidates is uncertain; 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 our product candidates will cause unexpected
safety events or result in an unmanageable safety profile as compared to
their level of efficacy; that duvelisib will be ineffective at treating
patients with lymphoid malignancies; that Verastem will be unable to
successfully initiate or complete the clinical development of its
product candidates; that the development of Verastem's product
candidates will take longer or cost more than planned; that Verastem may
not have sufficient cash to fund its contemplated operations; that
Verastem or Infinity Pharmaceuticals, Inc. (Infinity) will fail to fully
perform under the duvelisib license agreement; that Verastem may be
unable to make additional draws under its debt facility or obtain
adequate financing in the future through product licensing,
co-promotional arrangements, public or private equity, debt financing or
otherwise; that Verastem will not pursue or submit regulatory filings
for its product candidates, including for duvelisib in patients with CLL
or iNHL; and that Verastem's 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 Verastem's Annual Report on Form 10-K for the year ended December 31,
2016 and in any subsequent filings with the U.S. Securities and Exchange
Commission. The forward-looking statements contained in this press
release reflect Verastem's views as of the date of this release, and
Verastem does not undertake and specifically disclaims any obligation to
update any forward-looking statements.
References
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1 |
Winkler 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.
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2 |
Reif 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.
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3 |
Schmid 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.
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4 |
www.clinicaltrials.gov, NCT02004522
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5 |
www.clinicaltrials.gov, NCT01882803
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6 |
www.clinicaltrials.gov, NCT02783625, NCT02158091
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View source version on businesswire.com: http://www.businesswire.com/news/home/20171101006041/en/
Source: Verastem, Inc.
Verastem, Inc.
Brian Sullivan, 781-292-4214
Director,
Corporate Development
bsullivan@verastem.com