Results from the DUO™ crossover study with
duvelisib demonstrate superior ORR and PFS compared to prior
ofatumumab treatment and consistent with ORR in patients who were
initially treated with duvelisib in the DUO™ Study
Promising initial clinical activity of
defactinib, an oral FAK inhibitor, in combination with
pembrolizumab and gemcitabine in patients with pancreatic cancer
whose disease progressed on one or more prior lines of
chemotherapy
Verastem, Inc. (Nasdaq: VSTM) (Verastem Oncology or the
Company), a biopharmaceutical company focused on developing and
commercializing medicines to improve the survival and quality of
life of cancer patients, today announced that five abstracts have
been selected for poster presentations at the 54th Annual Meeting
of the American Society of Clinical Oncology (ASCO) being held June
1-5, 2018 in Chicago.
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, as well as defactinib, its
oral small molecule inhibitor of Focal Adhesion Kinase (FAK). The
poster presentations will highlight the latest findings from the
Company’s ongoing clinical trials for duvelisib, the Phase 3 DUO
study crossover extension in patients with relapsed or refractory
chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL),
in addition to a Phase 1 study of defactinib in combination with
pembrolizumab and gemcitabine in patients with relapsed/refractory
pancreatic cancer.
A poster will also be presented on PRIMO, a Phase II study that
Verastem Oncology has initiated to evaluate duvelisib monotherapy
in peripheral T-cell lymphoma (PTCL), one of the most aggressive
forms of non-Hodgkin lymphoma (NHL). The U.S. Food and Drug
Administration (FDA) has granted fast track designation to the
investigation of duvelisib for the potential treatment of patients
with peripheral T-cell lymphoma (PTCL) who have received at least
one prior therapy. This study was initiated based on promising
activity observed with duvelisib monotherapy in T-cell lymphomas in
the Phase I study. In addition, posters on biomarker measurements
in the DUOTM and DYNAMOTM studies, as well as in a treatment naive
follicular lymphoma study, will be presented.
“In the crossover extension trial of the Phase 3 DUO study,
patients treated with duvelisib following confirmed disease
progression on prior ofatumumab therapy exhibited a 73% overall
response rate (ORR), compared to a 28% ORR with ofatumumab in the
DUO study. These results were consistent with the ORR of patients
originally initiated on duvelisib. This response rate was
accompanied by a longer median progression-free survival (mPFS),
with duvelisib-treated patients achieving 15-month mPFS, compared
to 9 months when they were treated with ofatumumab,” said Diep Le,
MD, PhD, Chief Medical Officer of Verastem Oncology.
Dr. Le added, “For our lead FAK inhibitor defactinib, Dr. Andrea
Wang-Gillam will describe initial results from the ongoing Phase 1
study evaluating defactinib in combination with pembrolizumab and
gemcitabine in patients with advanced pancreatic cancer. In
addition to defining a recommended Phase 2 dose, the combination
regimen has been well tolerated with promising signs of clinical
activity, including one confirmed partial response in a pancreatic
cancer patient and stable disease in additional pancreatic
patients.”
“Data presented at this year’s ASCO meeting by Verastem Oncology
and collaborative researchers also directly demonstrate inhibition
of both PI3K-delta and PI3K-gamma in patients treated with
duvelisib,” said Jonathan Pachter, PhD, Chief Scientific Officer of
Verastem Oncology. “Accordingly, biomarker changes observed in
duvelisib-treated patients indicate targeting of malignant B-cells
directly along with targeting of the supportive tumor
microenvironment.”
Details for the ASCO 2018 presentations are as
follows:
Duvelisib
Title: The efficacy of duvelisib monotherapy following
disease progression on ofatumumab monotherapy in patients with
relapsed/refractory CLL or SLL in the DUO crossover extension
studyLead author: Dr. Bryone Kuss, Flinders Medical
CenterSession: Hematologic Malignancies – Lymphoma and
Chronic Lymphocytic LeukemiaPoster #: 170Abstract #:
7533Location: McCormick Place Hall ADate and Time:
Monday, June 4, 8:00 – 11:30 a.m. CT
Title: The effect of duvelisib, a dual inhibitor of
PI3K-δ,γ, on components of the tumor microenvironment in previously
untreated follicular lymphomaLead author: Dr. Carla Casulo,
University of Rochester, Wilmot Cancer CenterSession:
Hematologic Malignancies – Lymphoma and Chronic Lymphocytic
LeukemiaPoster #: 216Abstract #: 7579Location:
McCormick Place Hall ADate and Time: Monday, June 4, 8:00 –
11:30 a.m. CT
Title: The PRIMO study: A phase 2 study of duvelisib
efficacy and safety in patients with relapsed or refractory
peripheral t-cell lymphoma (PTCL)Lead author: Dr. Steven
Horwitz, Memorial Sloan Kettering Cancer CenterSession:
Hematologic Malignancies – Lymphoma and Chronic Lymphocytic
LeukemiaPoster #: 222bAbstract #:
TPS7590Location: McCormick Place Hall ADate and Time:
Monday, June 4, 8:00 – 11:30 a.m. CT
Title: Duvelisib inhibition of chemokines in patients
with CLL (DUO study) and iNHL (DYNAMO study)Lead author: Dr.
David Weaver, Verastem OncologySession: Tumor
BiologyPoster #: 161Abstract #: 12048Location:
McCormick Place Hall ADate and Time: Monday, June 4, 1:15 –
4:45 p.m. CT
Defactinib
Title: Phase I study of defactinib combined with
pembrolizumab and gemcitabine in patients with advanced
cancerLead author: Dr. Andrea Wang-Gillam, Washington
University School of Medicine in St. LouisSession:
Developmental Therapeutics – Clinical Pharmacology and Experimental
TherapeuticsPoster #: 387Abstract #:
2561Location: McCormick Place Hall ADate and Time:
Monday, June 4, 8:00 – 11:30 a.m. CT
About 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 Defactinib
Defactinib is an investigational inhibitor of focal adhesion
kinase (FAK), a non-receptor tyrosine kinase that mediates
oncogenic signaling in response to cellular adhesion and growth
factors.7 Based on the multi-faceted roles of FAK, defactinib is
used to treat cancer through modulation of the tumor
microenvironment and enhancement of anti-tumor immunity.8,9
Defactinib 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. These studies are combination clinical trials with
pembrolizumab and avelumab from Merck & Co. and Pfizer/Merck
KGaA, respectively.10,11,12 Information about these and additional
clinical trials evaluating the safety and efficacy of defactinib
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 drugs 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, NCT020045225
www.clinicaltrials.gov, NCT018828036 www.clinicaltrials.gov,
NCT02783625, NCT021580917 Schaller M.D. and Parsons J.T. Focal
adhesion kinase: an integrin-linked protein tyrosine kinase. Trends
Cell Biol. 1993 3: 258-62.8 Jiang H et al. Targeting focal adhesion
kinase renders pancreatic cancers responsive to checkpoint
immunotherapy. Nat Med 2016: Aug 22(8) 851-60.9 Sulzmaier F.J. et
al. FAK in cancer: mechanistic findings and clinical applications.
Nature Rev Cancer. 2014 14: 598-610.10 www.clinicaltrials.gov,
NCT0254653111 www.clinicaltrials.gov, NCT0294331712
www.clinicaltrials.gov, NCT02758587
View source
version on businesswire.com: https://www.businesswire.com/news/home/20180516006497/en/
Verastem OncologyMarianne M. Lambertson, +1
781-292-4273Vice President, Corporate CommunicationsInvestor
Relations/Public Relationsmlambertson@verastem.com
Verastem (NASDAQ:VSTM)
Historical Stock Chart
From Feb 2024 to Mar 2024
Verastem (NASDAQ:VSTM)
Historical Stock Chart
From Mar 2023 to Mar 2024