43% ORR per IRC in Patients with
Double-Refractory Follicular Lymphoma
68% ORR per IRC in Patients with
Double-Refractory Small Lymphocytic Lymphoma
Duvelisib Remains Well Tolerated in Long-Term
Follow Up
Verastem, Inc. (NASDAQ: VSTM), focused on discovering and
developing drugs to improve the survival and quality of life of
cancer patients, today announced the presentation of long-term
follow-up data from the DYNAMO™ study, which met its primary
endpoint of Overall Response Rate (ORR; p=0.0001) at the final
analysis, at the 22nd Congress of the European Hematology
Association (EHA), being held June 22-25, 2017 in Madrid, Spain.
DYNAMO is a Phase 2 clinical study evaluating duvelisib, the
Company’s investigational oral monotherapy, dual inhibitor of
phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, in patients
with indolent non-Hodgkin lymphoma (iNHL) whose disease is
refractory to both rituximab and chemotherapy or
radioimmunotherapy. The presentations focus on the subsets of
patients with follicular lymphoma (FL) or small lymphocytic
lymphoma (SLL) who were enrolled in DYNAMO.
Oral Duvelisib in Patients with Double-Refractory FL
With 18 months of follow-up, the data continues to be consistent
with the primary analysis. Of the 83 patients with
double-refractory FL enrolled in DYNAMO (median 3 prior anticancer
regimens [range 1-10]), 36 responded, which included 1 (1%)
complete response (CR) and 35 (42%) partial responses (PR), for an
ORR of 43% as determined by an independent review committee.
Responses generally occurred shortly after the start of treatment
(median 2 months). Notably, 83% of evaluable patients with FL
treated with duvelisib had a reduction in the size of their target
lymph nodes. Median duration of response was 7.9 months, median
progression-free survival was 8.3 months, and median overall
survival was 27.8 months.
The safety profile of duvelisib monotherapy remains consistent
with what has been previously reported in iNHL and other advanced
hematologic malignancies. In these double-refractory FL patients,
the most common Grade ≥3 hematologic adverse events were
neutropenia (22%), anemia (13%) and thrombocytopenia (9%). Diarrhea
was the most frequently reported nonhematologic adverse event (47%;
16% Grade ≥ 3). As expected in a heavily pretreated and refractory
patient population, severe infections were observed (20%).
Pneumonitis and colitis remained relatively uncommon (each 5%).
Treatment discontinuations attributed to severe adverse events were
infrequent, suggesting that these events were generally
manageable.
Oral Duvelisib in Patients with Double-Refractory SLL
Of the 28 patients with double-refractory SLL enrolled in DYNAMO
(median 3 prior anticancer regimens [range 1-18]), 19 responded,
all of which were PRs, for an ORR of 68% as determined by an
independent review committee. Responses generally occurred shortly
after the start of treatment (median 2 months). Importantly, 100%
of evaluable patients with double-refractory SLL treated with
duvelisib had a reduction in the size of their target lymph nodes.
With a median time on duvelisib of 12 months, median duration of
response was 10.1 months, median progression-free survival was 11.7
months, and median overall survival was 28.9 months.
In these double-refractory SLL patients, the most common Grade
≥3 hematologic adverse events were neutropenia (32%),
thrombocytopenia (21%) and anemia (21%). The most frequently
reported Grade ≥3 nonhematologic adverse events were pneumonia
(14%), increases in alanine aminotransferase (7%) and aspartate
aminotransferase (11%), and diarrhea (11%). As expected in a
heavily pretreated and refractory patient population, severe
infections were observed (36%). Colitis occurred in 3 (11%) SLL
patients. No double-refractory SLL patients experienced
pneumonitis. Treatment discontinuations attributed to the most
common adverse events were infrequent, suggesting that these events
were generally manageable.
“We believe that oral duvelisib has the potential to be an
important new treatment option for lymphoma patients,” commented
Pier Luigi Zinzani, MD, PhD, of the University of Bologna Institute
of Hematology and an Investigator participating in the study. “What
I find particularly encouraging are the responses we saw in
patients with double-refractory disease, a population with few
treatment options left. The data we are presenting at EHA continue
to demonstrate that duvelisib monotherapy can achieve meaningful
and durable responses.”
Hagop Youssoufian, MSc, MD, Head of Hematology and Oncology
Development at Verastem, stated, “The data from DYNAMO remain
positive, and reporting the results from long-term follow-up is
important for the medical community and for the overall development
of duvelisib. Oral duvelisib monotherapy has demonstrated clinical
activity across a number of hematologic cancers, including chronic
lymphocytic leukemia, iNHL, and T-cell lymphoma. Based on the
results we have seen thus far, we remain fully committed to
exploring duvelisib’s potential across a wide range of lymphoid
malignancies.”
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
LymphomaAbstract code: S777Topic: Indolent
Non-Hodgkin lymphoma – ClinicalSession title: Follicular
lymphoma – ClinicalLocation: Hall CDate 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 StudyAbstract code: E1130Topic: Indolent
Non-Hodgkin lymphoma – ClinicalLocation: e-poster
screensDate 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.
More About the Phase 2 DYNAMO™ Study
DYNAMO™ is a Phase 2, single-arm study, which evaluated the
efficacy and safety of duvelisib 25 mg twice daily as monotherapy
in 129 iNHL patients, including follicular lymphoma (n=83), small
lymphocytic lymphoma (n=28), and marginal zone lymphoma (n=18)
whose disease has progressed and are refractory to rituximab and to
either chemotherapy or radioimmunotherapy. The primary endpoint of
the study was ORR as assessed by an independent review committee.
DYNAMO met its primary ORR endpoint (p=0.0001) at the final
analysis.
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
response to therapy.
About Duvelisib
Duvelisib is an investigational, 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-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.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. 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 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 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 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, NCT02783625, NCT02158091
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Verastem, Inc.Brian Sullivan, 781-292-4214Director,
Corporate Developmentbsullivan@verastem.com
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