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
BOSTON--(BUSINESS WIRE)--Dec. 4, 2018--
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 Study
Presenter: Jennifer Brown,
Harvard Medical School and Dana-Farber Cancer Institute
Abstract
Number/Publication ID: 1856
Session: 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 Study
Presenter:
Matthew Davids, Dana-Farber Cancer Institute
Abstract
Number/Publication ID: 3140
Session: 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 Studies
Presenter: Ian
Flinn, Sarah Cannon Research Institute
Abstract
Number/Publication ID: 3146
Session: 642. CLL: Therapy,
excluding Transplantation: Poster II
Title: Simultaneous inhibition of BCL-2 and PI3K signaling
overcomes ibrutinib resistance in mantle cell lymphoma
Presenter:
Haige Ye, MD Anderson Cancer Center
Abstract
Number/Publication ID: 2950
Session: 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 iNHL
Presenter:
Pier Luigi Zinzani, University of Bologna Institute of Hematology
Abstract
Number/Publication ID: 4167
Session: 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 Model
Presenter: Shih-Shih
Chen, The Feinstein Institute for Medical Research, Northwell Health
Abstract
Number/Publication ID: 4420
Session: 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) FCR
Presenter:
Timothy Z. Lehmberg, Dana-Farber Cancer Institute
Abstract
Number/Publication ID: 4395
Session: 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/
Source: Verastem, Inc.
Verastem Oncology:
Brian Sullivan
Senior Director,
Corporate Development
+1-781-469-1636
bsullivan@verastem.com
Media:
Jeff Stoecker
FleishmanHillard
+1-617-692-0509
media@verastem.com
Investors:
Joseph Rayne
Argot Partners
+1-617-340-6075
joseph@argotpartners.com
