Combination of Duvelisib and Romidepsin Resulting in a 59% Overall
Response Rate in Relapsed or Refractory Peripheral T-Cell Lymphoma
BOSTON--(BUSINESS WIRE)--Dec. 3, 2018--
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.
References
1The Leukemia & Lymphoma Society.
Peripheral T-Cell Lymphoma Facts. July 2014.
2Leukemia
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/
Source: Verastem, Inc.
Verastem Oncology:
Brian Sullivan
Senior Director,
Corporate Development
+1 781-469-1636
bsullivan@verastem.com
Media:
Jeff
Stoecker
FleishmanHillard
+1 617-692-0509
media@verastem.com
Investors:
Joseph
Rayne
Argot Partners
+1 617-340-6075
joseph@argotpartners.com
