Abstract Highlighting Long-Term Follow Up Data from the DYNAMO® Study
of Duvelisib in Patients with Double-Refractory Follicular Lymphoma
Selected for Oral Presentation
BOSTON--(BUSINESS WIRE)--May 18, 2017--
Verastem, Inc. (NASDAQ:VSTM), focused on discovering and developing
drugs to improve the survival and quality of life of cancer patients,
today announced an abstract featuring long-term follow up data from the
DYNAMO® study evaluating duvelisib in patients with follicular lymphoma
(FL) has been selected for oral presentation at the 22ndCongress of the European Hematology Association (EHA) being held June
22-25, 2017 in Madrid, Spain. In addition, an abstract describing Phase
2 data, also from the DYNAMO study, evaluating duvelisib in patients
with small lymphocytic lymphoma (SLL) has been selected for an e-poster
presentation at the meeting. DYNAMO is a Phase 2 clinical trial
evaluating the safety and efficacy of duvelisib in patients with
indolent non-Hodgkin lymphoma (iNHL) that are double refractory to both
rituximab and chemotherapy.
“In the previously reported Phase 2 DYNAMO study results, duvelisib
monotherapy demonstrated statistically significant clinical activity in
iNHL patients, acheiving the primary endpoint with a 46% overall
response rate, and was generally well tolerated with a manageable safety
profile with appropriate risk mitigation,” said Hagop Youssoufian, MSc,
MD, Head of Hematology and Oncology Development at Verastem. “We look
forward to presenting the long-term follow up data in June.”
Details for the presentations at EHA 2017 are:
Oral Presentation
Title: DYNAMO: A Phase 2 Study Demonstrating the Clinical
Activity of Duvelisib in Patients with Double-Refractory Follicular
Lymphoma
Presenter: Pier Luigi Zinzani, MD, PhD, University
of Bologna Institute of Hematology
Abstract code: S777
Topic:
Indolent Non-Hodgkin lymphoma – Clinical
Session title:
Follicular lymphoma – Clinical
Location: Hall C
Date
and time: Sunday, June 25, 2017, 8:45 – 9:00 CET
A copy of the oral presentation slides will be available here
following the conclusion of the oral presentation.
E-Poster Presentation
Title: DYNAMO: The Clinical Activity of Duvelisib in Patients
with Double-Refractory Small Lymphocytic Lymphoma in a Phase 2 Study
Abstract
code: E1130
Topic: Indolent Non-Hodgkin lymphoma –
Clinical
Location: e-poster screens
Date and time:
Friday, June 23, 2017 from 9:30 CET to Saturday, June 24, 2017 at 19:00
CET
A copy of the e-poster presentation will be available here
following the conclusion of the meeting.
About the Tumor Microenvironment
The tumor microenvironment encompasses multiple tumor and non-tumor cell
populations and an extracellular matrix that support cancer cell
survival. This includes immunosuppressive regulatory T-cells,
myeloid-derived suppressor cells, tumor-associated macrophages,
cancer-associated fibroblasts and extracellular matrix proteins that can
hamper the entry and therapeutic benefit of cytotoxic T-cells and
anti-cancer drugs. In addition to targeting the proliferative and
survival signaling of cancer cells, Verastem’s product candidates,
including duvelisib and defactinib, also target the tumor
microenvironment to potentially improve a patient’s response to therapy.
About Duvelisib
Duvelisib is an investigational, dual inhibitor of phosphoinositide
3-kinase (PI3K)-delta and PI3K-gamma, two enzymes that are 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 clinical trials,
including DUO™, a randomized, Phase 3 monotherapy study in patients with
relapsed or refractory CLL,4 and DYNAMO™, a single-arm, Phase
2 monotherapy study in patients with refractory iNHL that achieved its
primary endpoint of ORR upon top-line analysis of efficacy data.5
Duvelisib is also being evaluated for the treatment of hematologic
malignancies through investigator-sponsored studies, including T-cell
lymphoma.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 iNHL and is currently being evaluated in
a Phase 3 clinical trial in patients with CLL. 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 our rights to develop or commercialize our product
candidates. 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 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; 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. will fail to fully perform under the duvelisib license agreement;
that Verastem will not pursue or submit regulatory filings for its
product candidates; 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
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.
4www.clinicaltrials.gov,
NCT02004522
5www.clinicaltrials.gov,
NCT01882803
6www.clinicaltrials.gov,
NCT02783625, NCT02783625, NCT02158091
View source version on businesswire.com: http://www.businesswire.com/news/home/20170518005559/en/
Source: Verastem, Inc.
Verastem, Inc.
Brian Sullivan, 781-292-4214
Director,
Corporate Development
bsullivan@verastem.com