Results from the Dose Optimization Portion of
the Study to be Presented
PRIMO Expansion Phase To Investigate Duvelisib
75mg Twice Daily for Two Cycles, Followed by 25mg Twice Daily
Four Additional Abstracts Selected for
Presentation, Including Results from a Phase 1 Study Investigating
Duvelisib in Combination with Venetoclax in Patients with Relapsed
or Refractory CLL/SLL
Verastem, Inc. (Nasdaq:VSTM) (Verastem Oncology or the Company),
a biopharmaceutical company focused on developing and
commercializing medicines seeking to improve the survival and
quality of life of cancer patients, today announced that five
abstracts highlighting data for COPIKTRA™ (duvelisib) have been
selected for presentation at the upcoming American Society of
Hematology 2019 Annual Meeting taking place December 7-10, 2019, in
Orlando.
“We are pleased to share additional data on duvelisib across
multiple areas of research that continues to expand our
understanding of its potential benefit and utility for patients
with certain types of blood cancers,” said Brian Stuglik, Chief
Executive Officer of Verastem Oncology. “The results of the dose
optimization portion of the PRIMO study provide important guidance
to support our ongoing evaluation of duvelisib for the treatment of
relapsed or refractory PTCL.”
A key abstract at the meeting will feature clinical data from
the dose optimization portion of the registration-directed Phase 2
PRIMO study evaluating duvelisib in patients with relapsed or
refractory peripheral T-cell lymphoma (PTCL). This open-label,
multicenter trial is currently ongoing and is expected to enroll
approximately 120 patients. In the dose optimization portion of the
study, patients were randomized to receive duvelisib 25mg twice
daily with an option for dose escalation (cohort 1) or duvelisib
75mg twice daily continuously (cohort 2) until disease progression
or unacceptable toxicity (cycle=28 days).
The primary endpoint of the dose optimization portion is
investigator-assessed overall response rate (ORR). Based on the
efficacy and safety data to be reported at the meeting, the
investigators have elected to investigate duvelisib starting at
75mg twice daily for two cycles, followed by 25mg twice daily,
during the dose expansion portion of the study which is currently
ongoing. Updated data from those shown in the abstract will be
presented at the meeting. Duvelisib is not approved for the
treatment of PTCL.
“Identifying additional options for this aggressive type of
T-cell lymphoma is critical. In the initial cohort of this trial,
we identified that the dose of 75mg twice daily for two cycles
helped to achieve more rapid tumor control in what are often
aggressive diseases. We will assess if following the induction by
25mg twice daily dose we are able to maintain longer-term disease
control and mitigate the potential for later onset toxicities in
patients with relapsed or refractory PTCL,” said Steven Horwitz,
MD, Memorial Sloan Kettering Cancer Center, and principal
investigator of Phase 2 PRIMO study. “We look forward to sharing
updated data from this ongoing study at ASH 2019.”
Other abstracts at the meeting include: Preliminary results from
a Phase 1 study investigating duvelisib in combination with
venetoclax in patients with relapsed or refractory chronic
lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL); an
analysis of cytogenetic and molecular markers associated with
improved outcomes in the Phase 3 DUO study; and a description of
the [soon to be initiated] TEMPO study investigating an
intermittent dosing regimen of duvelisib in patients with indolent
non-Hodgkin lymphoma. Preclinical data highlighting the
effectiveness of duvelisib in combination with venetoclax in
Richter syndrome will also be presented.
Details for the ASH 2019 presentations are as
follows:
Poster Presentations
Title: Dose Optimization of Duvelisib in Patients with
Relapsed or Refractory Peripheral T-Cell Lymphoma from the Phase 2
PRIMO Trial: Selection of Regimen for the Dose-Expansion Phase
Lead author: Steven Horwitz, Memorial Sloan Kettering Cancer
Center Poster #: 1567 Session: 624. Hodgkin Lymphoma
and T/NK Cell Lymphoma – Clinical Studies: Poster I Date and
Time: Saturday, December 7, 2019; 5:30-7:30PM ET
Location: Orange County Convention Center, Hall B
Title: A Phase I Study of Duvelisib and Venetoclax in
Patients with Relapsed or Refractory CLL / SLL Lead author:
Jennifer Crombie, Dana-Farber Cancer Institute Poster #:
1763 Session: 642. CLL: Therapy, excluding Transplantation:
Poster I Date and Time: Saturday, December 7, 2019;
5:30-7:30 PM ET Location: Orange County Convention Center,
Hall B
Title: Cytogenetic and Molecular Marker Associations to
Outcomes with Duvelisib and Ofatumumab Treatment in Patients with
Relapsed or Refractory CLL/SLL in the DUO Trial Lead author:
Jennifer Brown, Dana-Farber Cancer Institute Poster #: 4312
Session: 642. CLL: Therapy, excluding Transplantation:
Poster III Date and Time: Monday, December 9, 2019;
6:00-8:00 PM ET Location: Orange County Convention Center,
Hall B
Title: The Dual PI3K-δ/γ Inhibitor Duvelisib in
Combination with the Bcl-2 Inhibitor Venetoclax Shows Promising
Responses in Richter Syndrome-PDX Models Lead author: Andrea
Iannello, Università degli Studi di Torino Poster #: 2862
Session: 625. Lymphoma: Pre-Clinical—Chemotherapy and
Biologic Agents: Poster II Date and Time: Sunday, December
8, 6:00-8:00 PM ET Location: Orange County Convention
Center, Hall B
Publication Only Presentations
Title: Trial in Progress (TiP): A Phase 2,
Randomized, Open-Label, 2-Arm Study Comparing 2 Intermittent Dosing
Schedules of Duvelisib in Patients with Indolent Non-Hodgkin
Lymphoma (iNHL) (TEMPO) Lead author: Reem Karmali, Lurie
Cancer Center, Northwestern University Session: 623. Mantle
cell, follicular, and other indolent B Cell Lymphoma – Clinical
studies
PDF copies of these poster presentations will be available
here after the meeting.
COPIKTRA is indicated for the treatment of adult patients with
relapsed or refractory chronic lymphocytic leukemia (CLL) or small
lymphocytic lymphoma (SLL)_after at least two prior therapies and
in relapsed or refractory follicular lymphoma (FL) after at least
two prior system therapies. Accelerated approved in FL was based on
overall response rate and continued approval may be contingent upon
confirmatory trials.
COPIKTRA includes a Boxed Warning for fatal and serious
toxicities including infections, diarrhea or colitis, cutaneous
reactions and pneumonitis. See full Prescribing Information for
complete Boxed Warning and other important safety information.
SELECT IMPORTANT SAFETY INFORMATION
This does not include all information needed to use COPIKTRA™
(duvelisib) safely and effectively. See full Prescribing
Information.
WARNING: FATAL AND SERIOUS TOXICITIES:
INFECTIONS, DIARRHEA OR COLITIS, CUTANEOUS REACTIONS, and
PNEUMONITIS
See full Prescribing
Information for complete boxed warning
- Fatal and/or serious infections occurred in 31% (4% fatal) of
COPIKTRA-treated patients. Monitor for signs and symptoms of
infection. Withhold COPIKTRA if infection is suspected.
- Fatal and/or serious diarrhea or colitis occurred in 18%
(<1% fatal) of COPIKTRA-treated patients. Monitor for the
development of severe diarrhea or colitis. Withhold COPIKTRA.
- Fatal and/or serious cutaneous reactions occurred in 5% (<1%
fatal) of COPIKTRA-treated patients. Withhold COPIKTRA.
- Fatal and/or serious pneumonitis occurred in 5% (<1% fatal)
of COPIKTRA-treated patients. Monitor for pulmonary symptoms and
interstitial infiltrates. Withhold COPIKTRA.
WARNINGS AND PRECAUTIONS
- Hepatotoxicity: Monitor hepatic function.
- Neutropenia: Monitor blood counts.
- Embryo-Fetal toxicity: COPIKTRA can cause fetal harm. Advise
patients of potential risk to a fetus and to use effective
contraception.
ADVERSE REACTIONS
The most common adverse reactions (≥20%) are diarrhea or
colitis, neutropenia, rash, fatigue, pyrexia, cough, nausea, upper
respiratory infection, pneumonia, musculoskeletal pain, and
anemia.
To report Adverse Reactions, contact FDA at 1-800-FDA-1088
(1-800-332-1088) or www.fda.gov/medwatch and Verastem Oncology at
1-877-7RXVSTM (1-877-779-8786).
DRUG INTERACTIONS
- CYP3A inducers: Avoid co-administration with strong CYP3A
inducers.
- CYP3A inhibitors: Monitor for COPIKTRA toxicities when
co-administered with strong or moderate CYP3A inhibitors. Reduce
COPIKTRA dose to 15 mg twice daily when co-administered with strong
CYP3A4 inhibitors.
- CYP3A substrates: Monitor for signs of toxicities when
co-administering COPIKTRA with sensitive CYP3A substrates.
USE IN SPECIFIC POPULATIONS Lactation: Advise women not
to breastfeed.
About COPIKTRA™ (duvelisib)
COPIKTRA is an oral inhibitor of phosphoinositide 3-kinase
(PI3K), and the first approved dual inhibitor of PI3K-delta and
PI3K-gamma, two enzymes known to help support the growth and
survival of malignant B-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 COPIKTRA is indicated for the treatment of
adult patients with relapsed or refractory chronic lymphocytic
leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two
prior therapies and relapsed or refractory follicular lymphoma (FL)
after at least two prior systemic therapies. COPIKTRA is also being
developed by Verastem Oncology for the treatment of peripheral
T-cell lymphoma (PTCL), for which it has received Fast Track status
and Orphan Drug Designation, and is being investigated in
combination with other agents through investigator-sponsored
studies.4 For more information on COPIKTRA, please visit
www.COPIKTRA.com. Information about duvelisib clinical trials can
be found on www.clinicaltrials.gov.
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 within
the meaning of the Private Securities Litigation Reform Act of 1995
that are subject to risks, uncertainties and other factors,
including those related to the safety and efficacy of COPIKTRA; the
uncertainties inherent in research and development of COPIKTRA,
such as negative or unexpected results of clinical trials; that
enrollment of clinical trials may take longer than expected; and
that COPIKTRA or our 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. These risks, uncertainties and other
factors could cause actual results to differ materially from those
referred to in the forward-looking statements. The reader is
cautioned not to rely on these forward-looking statements.
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 June 30, 2019, as filed with
the Securities and Exchange Commission (SEC) on August 1, 2019, its
Annual Report on Form 10-K for the year ended December 31, 2018 as
filed with the SEC on March 12, 2019 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, NCT03372057.
Dr. Horwitz has been compensated for consulting services by
Verastem Oncology and also receives research support from the
company.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20191106005590/en/
Investors: John Doyle Vice President, Investor Relations &
Finance +1 781-469-1546 jdoyle@verastem.com
Media: Lisa Buffington Corporate Communications +1 781-292-4205
lbuffington@verastem.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