In a phase Ib/II investigational study of
duvelisib, a dual inhibitor of PI3K-δ,γ in combination with FCR
(dFCR) for frontline therapy of younger CLL patients, dFCR was
observed to be a highly active regimen, achieving ORR of 97% and
81% bone marrow MRD negativity
Additional data presentations support the
hypothesis that duvelisib targets malignant B-cells directly and
modulates the tumor microenvironment, as well as demonstrate robust
clinical activity of duvelisib in patients relapsed/refractory to
ofatumamab
Verastem Oncology (Nasdaq:VSTM), a biopharmaceutical company
focused on developing and commercializing medicines to improve the
survival and quality of life of cancer patients, today announced
the selection of four abstracts for oral and poster presentations
at the 23rd Congress of the European Hematology Association (EHA)
being held June 14-17, 2018 in Stockholm, Sweden.
The Company will present data on its lead product candidate,
duvelisib, a first-in-class oral dual inhibitor of phosphoinositide
3-kinase (PI3K)-delta and PI3K-gamma. An oral presentation by Dr.
Matthew Davids, Dana-Farber Cancer Institute, will highlight the
latest data from a Phase Ib/II study of duvelisib in combination
with FCR (dFCR) as a frontline treatment in younger patients with
chronic lymphocytic leukemia (CLL). Three posters will highlight
additional duvelisib data, including crossover extension results
from the Phase 3 DUO™ study in patients with relapsed or refractory
CLL/small lymphocytic lymphoma (CLL/SLL), and new biomarker
analyses on the tumor microenvironment modulation from DUOTM and
the Phase 2 DYNAMOTM study in patients with refractory indolent
non-Hodgkin lymphoma (iNHL), and the dual PI3K-delta and PI3K-gamma
activity of duvelisib in the CONTEMPOTM study in patients with
untreated follicular lymphoma who are treated with duvelisib in
combination with CD20 antibody immunotherapy.
“At EHA 2018, Dr. Matthew Davids will deliver an oral
presentation describing results from the ongoing Phase Ib/II study
evaluating duvelisib in combination with FCR (chemo-immunotherapy)
in younger CLL patients,” said Diep Le, MD, PhD, Chief Medical
Officer of Verastem Oncology. “To date, the combination regimen has
shown to be effective as an initial therapy with an ORR of 97%,
including 28% of evaluable patients achieving a complete response
or complete response with incomplete blood count recovery, and 69%
achieving a partial response. A high rate of 81% bone marrow MRD
negativity was observed in patients with at least one evaluation.
Collectively, the data being presented at EHA this year continue to
provide important insights to guide the future clinical development
of duvelisib across a wide range of hematologic malignancies, both
as a monotherapy and in combination with other agents.”
Details for the EHA 2018 presentation and posters are as
follows:
Oral Presentation
Title: A Phase IB/II Study of duvelisib in combination
with FCR (DFCR) for Frontline Therapy of Younger CLL
PatientsLead author: Dr. Matthew Davids, Dana-Farber Cancer
InstituteTopic: Chronic lymphocytic leukemia and related
disorders - ClinicalSession Title: Combination treatment
with targeted agents in CLLDate and Time: Saturday, June 16,
12:15 - 12:30 CESTLocation: Victoria HallFinal Abstract
Code: S807
Poster Presentations
Title:The Efficacy of Duvelisib Monotherapy Following
Disease Progression on Ofatumumab Monotherapy in Patients with
Relapsed/Refractory CLL or SLL in a Phase 3 Crossover Extension
StudyLead author: Dr. Bryone Kuss, Flinders Medical
CenterTopic: Chronic lymphocytic leukemia and related
disorders - ClinicalSession Title: Chronic lymphocytic
leukemia and related disorders - ClinicalDate and Time:
Friday, June 15, 17:30 - 19:00 CESTLocation: Poster
areaFinal Abstract Code: PF354Title: The effect of
duvelisib, a dual inhibitor of PI3K-δ,γ, on components of the tumor
microenvironment in previously untreated follicular
lymphoma.Lead author: Dr. Carla Casulo, University of
Rochester, Wilmot Cancer CenterTopic: Non-Hodgkin lymphoma
Biology & Translational ResearchSession Title:
Non-Hodgkin lymphoma Biology & Translational ResearchDate
and Time: Friday, June 15, 17:30 - 19:00 CESTLocation:
Poster areaFinal Abstract Code: PF646
Title: Duvelisib inhibition of chemokines in patients
with CLL (DUO study) and iNHL (DYNAMO study).Lead author:
Dr. David Weaver, Verastem OncologyTopic: Non-Hodgkin
lymphoma Biology & Translational ResearchSession Title:
Non-Hodgkin lymphoma Biology & Translational ResearchDate
and Time: Friday, June 15, 17:30 - 19:00 CESTLocation:
Poster areaFinal Abstract Code: PF649About
Duvelisib
Duvelisib is a first-in-class investigational oral, 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- and T-cells and is thought to play a
role in the formation and maintenance of the supportive tumor
microenvironment.1,2,3 Duvelisib was 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/small lymphocytic lymphoma (CLL/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. Verastem Oncology’s 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) was accepted for
filing by the U.S. Food and Drug Administration (FDA), granted
Priority Review and assigned a target action date of October 5,
2018. Duvelisib is also being developed by Verastem Oncology 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 Oncology
Verastem, Inc. (Nasdaq:VSTM), operating as Verastem Oncology, is
a biopharmaceutical company focused on developing and
commercializing medicines to improve the survival and quality of
life of cancer patients. Verastem Oncology 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/small lymphocytic
lymphoma (CLL/SLL). Verastem Oncology’s 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) was accepted for filing by the U.S. Food
and Drug Administration (FDA), granted Priority Review and assigned
a target action date of October 5, 2018. In addition, Verastem
Oncology 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 (NSCLC), and
mesothelioma. Verastem Oncology’s product candidates seek to treat
cancer by modulating the local tumor microenvironment and enhancing
anti-tumor immunity. 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 investigational product candidates, including duvelisib
and defactinib, and Verastem Oncology’s PI3K and FAK programs
generally, the structure of our planned and pending clinical
trials, Verastem Oncology’s financial guidance 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 approval of Verastem
Oncology’s New Drug Application for duvelisib will not occur on the
expected timeframe or at all, including by the U.S. Food and Drug
Administration’s target action date; that a filing of a European
Marketing Application may not be achieved in fiscal year 2019 or at
all; that even if data from clinical trials is positive, regulatory
authorities may require additional studies for approval or may
approve for indications or patient populations that are not as
broad as intended and the product may not prove to be safe and
effective or may require labeling with use or distribution
restrictions; that the preclinical testing of Verastem Oncology’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 the full data from the DUO study
will not be consistent with the previously presented results of the
study; that data may not be available when expected, including for
the Phase 3 DUO study; 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 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 iNHL; 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 Annual Report on Form 10-K for the year ended December
31, 2017 as filed with the Securities and Exchange Commission (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.
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, NCT02004522
5 www.clinicaltrials.gov, NCT01882803
6 www.clinicaltrials.gov, NCT02783625, NCT02158091
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version on businesswire.com: https://www.businesswire.com/news/home/20180517005838/en/
Verastem Oncology, Inc.Marianne M. LambertsonVice
President, Corporate CommunicationsInvestor Relations/Public
Relations+1 781-292-4273mlambertson@verastem.com
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