Multiple Clinical Data Presentations
Highlighting Updated Long-Term Follow-Up from the Phase 3 DUO and
the DUO Crossover Extension Studies
New Preclinical Research Suggests Duvelisib
Overcomes Ibrutinib Resistance in CLL Models through Elimination of
Malignant B Cells and Disruption of the Supportive Tumor
Microenvironment
Verastem, Inc. (Nasdaq:VSTM) (Verastem Oncology or the Company),
focused on developing and commercializing medicines to improve the
survival and quality of life of cancer patients, today announced
the presentation of seven posters highlighting new and updated
clinical and preclinical data from its duvelisib development
program at the American Society of Hematology (ASH) 2018 Annual
Meeting, taking place December 1-4, 2018, in San Diego. Duvelisib
is an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the
first approved dual inhibitor of PI3K-delta and PI3K-gamma.
“The PI3K pathway is critical for the survival and proliferation
of many types of cancer cells,” said Robert Forrester, Verastem
President and Chief Executive Officer. “At Verastem Oncology we are
committed to progressing the scientific research and clinical
development with our corporate, clinical and academic research
partners worldwide to unlock the potential of PI3K inhibition and
usher in new treatment strategies for patients in need.”
“Research being presented at ASH this year by Chen, et al used
CLL patient samples to demonstrate critical points about dual
PI3K-delta and PI3K-gamma inhibition,” said Jonathan Pachter, PhD,
Chief Scientific Officer at Verastem Oncology. “This research
suggests that while PI3K-delta inhibition targets the malignant B
cells directly, PI3K-gamma inhibition blocks the support of CLL
growth by macrophages and T cells in the tumor microenvironment.
Data presented show that when CLL cells from patients who
progressed on ibrutinib were implanted in mice, dual PI3K-delta and
PI3K-gamma inhibition effectively reduced the CLL burden thereby
suggesting the potential value of the dual inhibition in tumors
resistant to BTK inhibition. The importance of dual inhibition of
PI3K-delta and PI3K-gamma, in this case in combination with BCL-2
inhibition, was also described by Ye, et al in an aggressive
lymphoma model. This study highlights the synergistic activity of
the combination in inhibiting ibrutinib resistance compensatory
pathways and inducing apoptosis in preclinical models of Mantle
Cell Lymphoma.”
“We are delighted to have presented a wide range of data from
our ongoing duvelisib development programs, including updated
long-term follow-up data from the Phase 3 DUO study as well as the
DUO crossover extension study,” said Hagop Youssoufian, MSc, MD,
Head of Medical Strategy at Verastem Oncology. “Other key
presentations include the Zinzani and Lehmberg data, which describe
compelling new biomarker research being conducted relating to
predictive factors for response to duvelisib in certain hematologic
malignancies.”
Details for the ASH 2018 poster presentations are as
follows:
Poster Presentations
Title: Clinical and Biological Indicators of Duvelisib
Efficacy in CLL from the Phase 3 DUO StudyPresenter:
Jennifer Brown, Harvard Medical School and Dana-Farber Cancer
InstituteAbstract Number/Publication ID: 1856Session:
642. CLL: Therapy, excluding Transplantation: Poster I
Title: The Efficacy and Safety of Duvelisib Following
Disease Progression on Ofatumumab in Patients with
Relapsed/Refractory CLL or SLL: Updated Results from the DUO
Crossover Extension StudyPresenter: Matthew Davids,
Dana-Farber Cancer InstituteAbstract Number/Publication ID:
3140Session: 642. CLL: Therapy, excluding Transplantation:
Poster II
Title: Characterization of the Long-Term Efficacy and
Safety of Duvelisib Monotherapy in Patients with
Relapsed/Refractory CLL/SLL on Treatment for > 2 Years across 4
Clinical StudiesPresenter: Ian Flinn, Sarah Cannon Research
InstituteAbstract Number/Publication ID: 3146Session:
642. CLL: Therapy, excluding Transplantation: Poster II
Title: Simultaneous inhibition of BCL-2 and PI3K
signaling overcomes ibrutinib resistance in mantle cell
lymphomaPresenter: Haige Ye, MD Anderson Cancer
CenterAbstract Number/Publication ID: 2950Session: 625.
Lymphoma: Pre-Clinical—Chemotherapy and Biologic Agents: Poster
II
Title: Prognostic and Immune-Related Factors for Response
to Duvelisib in the Phase 2 DYNAMO Clinical Trial in
iNHLPresenter: Pier Luigi Zinzani, University of Bologna
Institute of HematologyAbstract Number/Publication ID:
4167Session: 623. Mantle Cell, Follicular, and Other
Indolent B-Cell Lymphoma—Clinical Studies: Poster III
Title: Dual Inhibition of PI3K-δ and PI3K-γ by Duvelisib
Impairs CLL B Cells and CLL-Supporting Cells and Overcomes
Ibrutinib Resistance in a Patient-Derived Xenograft
ModelPresenter: Shih-Shih Chen, The Feinstein Institute for
Medical Research, Northwell HealthAbstract Number/Publication
ID: 4420Session: 642. CLL: Therapy, excluding
Transplantation: Poster III
Title: Dynamic BH3 Profiling Predicts Patient Response
and MRD Status in Chronic Lymphocytic Leukemia (CLL) Patients
Undergoing Frontline Treatment with Kinase Inhibitor Augmented
(KIA) FCRPresenter: Timothy Z. Lehmberg, Dana-Farber Cancer
InstituteAbstract Number/Publication ID: 4395Session:
641. CLL: Biology and Pathophysiology, excluding Therapy: Poster
III
PDF copies of these poster presentations will be available here
following the conclusion of the meeting.
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, including
statements regarding the development and activity of Verastem
Oncology’s lead product duvelisib, and Verastem Oncology’s PI3K and
FAK programs generally, its intent to commercialize duvelisib, the
potential commercial success of duvelisib, the anticipated adoption
of duvelisib by patients and physicians, the structure of its
planned and pending clinical trials and the timeline and
indications for clinical development, regulatory submissions and
commercialization activities. 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, among other things, uncertainties regarding
the commercial success of duvelisib in the United States;
uncertainties regarding physician and patient adoption of
duvelisib, including those related to the safety and efficacy of
duvelisib; the uncertainties inherent in research and development
of duvelisib, such as negative or unexpected results of clinical
trials; whether and when any applications for duvelisib 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
duvelisib, 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 duvelisib will be commercially successful in such
jurisdictions; Verastem Oncology’s ability to obtain, maintain and
enforce patent and other intellectual property protection for
duvelisib and its 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 duvelisib; that
regulatory authorities in the U.S. or other jurisdictions, if
approved, could withdraw approval; whether preclinical testing of
Verastem Oncology’s 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 Verastem Oncology’s product
candidates is uncertain; the risk that third party payors
(including government agencies) will not reimburse for duvelisib;
that there may be competitive developments affecting its product
candidates; that data may not be available when expected; that
enrollment of clinical trials may take longer than expected; that
duvelisib or Verastem Oncology’s 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 duvelisib
will be ineffective at treating patients with lymphoid
malignancies; that Verastem Oncology will be unable to successfully
initiate or complete the clinical development and eventual
commercialization of its product candidates; that the development
and commercialization of Verastem Oncology’s product candidates
will take longer or cost more than planned; that Verastem Oncology
may not have sufficient cash to fund its contemplated operations;
that Verastem Oncology or Infinity Pharmaceuticals, Inc. will fail
to fully perform under the duvelisib license agreement; that
Verastem Oncology 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 Oncology will
not pursue or submit regulatory filings for its product candidates,
including for duvelisib in patients with CLL/SLL or FL in other
jurisdictions; and that Verastem Oncology’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 the Company’s Quarterly Report on Form
10-Q for the quarterly period ended September 30, 2018 as filed
with the Securities and Exchange Commission (SEC) on November 7,
2018, its Annual Report on Form 10-K for the year ended December
31, 2017 as filed with the SEC on March 13, 2018 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20181204005276/en/
Verastem Oncology:Brian SullivanSenior Director, Corporate
Development+1-781-469-1636bsullivan@verastem.com
Media:Jeff
StoeckerFleishmanHillard+1-617-692-0509media@verastem.com
Investors:Joseph RayneArgot
Partners+1-617-340-6075joseph@argotpartners.com
Verastem (NASDAQ:VSTM)
Historical Stock Chart
From Mar 2024 to Apr 2024
Verastem (NASDAQ:VSTM)
Historical Stock Chart
From Apr 2023 to Apr 2024