Combination of Duvelisib and Romidepsin
Resulting in a 59% Overall Response Rate in Relapsed or Refractory
Peripheral T-Cell Lymphoma
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 an
oral presentation highlighting new clinical data from an
investigator sponsored trial, led by Steven Horwitz, MD, Memorial
Sloan Kettering Cancer Center (MSK), evaluating duvelisib in
combination with romidepsin in patients with relapsed or refractory
T-cell lymphomas, including peripheral T-cell lymphoma (PTCL) and
cutaneous T-cell lymphoma (CTCL) 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 data demonstrate that the combination of oral duvelisib and
romidepsin has an acceptable safety profile and the presence of
early signals of anti-lymphoma activity in patients with PTCL,”
said Steven Horwitz, MD, Memorial Sloan Kettering Cancer Center
(MSK), co-principal investigator of the Phase 1 study, and lead
author of the oral presentation. “The response rate observed to
date from the combination is compelling considering that PTCL is an
aggressive type of non-Hodgkin lymphoma for which new therapies are
desperately needed. We look forward to further elucidating the
potential of this novel combination regimen through completion of
this expansion cohort.”
Phase 1 Results with Duvelisib and Romidepsin in Relapsed or
Refractory PTCL
In this multicenter, dose-expansion portion of the Phase 1
trial, oral duvelisib was dosed at 75mg twice-daily (BID) on days
1-28. Romidepsin 10mg/m2 was dosed on Days 1, 8, and 15 on a 28-day
cycle. Of the 38 patients evaluable for efficacy (PTCL, n=27; CTCL,
n=11), 21 responded (9 complete responses (CRs) and 12 partial
responses (PRs)) for an overall response rate (ORR) of 55%. Sixteen
of the 27 patients with PTCL responded (9 CRs and 7 PRs) for an ORR
of 59%. Five of the 11 patients with CTCL responded (all PRs) for
an ORR of 45%. Median progression-free survival (PFS) for patients
with PTCL was 6.72 months and 5.41 months for patients with CTCL.
Among the 39 patients evaluable for safety, the most common Grade
≥3 adverse events were neutropenia (33%), diarrhea (15%) and
increased alanine aminotransferase (13%).
A PDF copy of the oral presentation will be available here
following the conclusion of the session.
Verastem Oncology is currently conducting an open-label,
multicenter, Phase 2 clinical trial (the PRIMO study; NCT03372057)
evaluating the efficacy and safety of duvelisib monotherapy in
adult patients with histologically confirmed relapsed or refractory
PTCL. This study is expected to enroll approximately 120
patients.
In addition, Verastem Oncology’s PTCL program was recently
selected to participate in The Leukemia and Lymphoma Society’s®
Therapy Acceleration Program® which provides additional resources
to support the development of therapies for patients with blood
cancers. The program is supporting work on translational biomarkers
of response, patient enrollment acceleration in PRIMO and an
increase in the total patient enrollment in the combination study
of duvelisib and romidepsin being presented at ASH.
Details for presentation are as follows:
Oral Presentation
Title: The combination of Duvelisib, a PI3K-δ,γ
Inhibitor, and Romidepsin is highly active in relapsed/refractory
peripheral T-cell lymphoma with low rates of transaminitis: Results
of a multicenter, multi-arm phase 1 study with expansion
cohorts Presenter: Steven Horwitz, Memorial Sloan
Kettering Cancer Center and NYC Health +
Hospitals/Bellevue Abstract Number/Publication ID:
683 Session: 624. Hodgkin Lymphoma and T/NK Cell
Lymphoma—Clinical Studies: Immunotherapy and Targeted
Strategies
About Peripheral T-Cell Lymphoma
Peripheral T-cell lymphoma (PTCL) is a rare, aggressive type of
non-Hodgkin lymphoma (NHL) that develops in mature white blood
cells called “T cells” and “natural killer (NK) cells”1 which
circulate with the lymphatic system.2 PTCL accounts for between
10-15% of all non-Hodgkin lymphomas (NHLs) and generally affects
people aged 60 years and older.1 Although there are many different
subtypes of peripheral T-cell lymphoma, they often present in a
similar way, with widespread, enlarged, painless lymph nodes in the
neck, armpit or groin.2 There is currently no established standard
of care for patients with relapsed or refractory disease.1
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.
References1 The Leukemia & Lymphoma Society.
Peripheral T-Cell Lymphoma Facts. July 2014.2 Leukemia Foundation.
http://www.leukaemia.org.au/blood-cancers/lymphomas/non-hodgkin-lymphoma-nhl/peripheral-t-cell-lymphoma
View source
version on businesswire.com: https://www.businesswire.com/news/home/20181203005998/en/
Verastem Oncology:Brian SullivanSenior Director, Corporate
Development+1 781-469-1636bsullivan@verastem.comMedia:Jeff
StoeckerFleishmanHillard+1
617-692-0509media@verastem.comInvestors:Joseph RayneArgot
Partners+1 617-340-6075joseph@argotpartners.com
Verastem (NASDAQ:VSTM)
Historical Stock Chart
From Aug 2024 to Sep 2024
Verastem (NASDAQ:VSTM)
Historical Stock Chart
From Sep 2023 to Sep 2024