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 its
partner Yakult Honsha Co., Ltd. (Yakult) has dosed the first
patient in a Phase 1b Japanese bridging study evaluating COPIKTRA®
(duvelisib) in patients with relapsed or refractory chronic
lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) following
at least one prior therapy. COPIKTRA is an oral inhibitor of
phosphoinositide 3-kinase (PI3K), and the first approved dual
inhibitor of PI3K-delta and PI3K-gamma in the United States.
“The start of patient dosing in Yakult’s first clinical study of
COPIKTRA in Japan is another important step forward in Verastem
Oncology’s strategy to expand the global potential of COPIKTRA for
hematological malignancies across the globe,” said Brian Stuglik,
Chief Executive Officer of Verastem Oncology. “The results of this
study are expected to form the basis of a regulatory submission for
COPIKTRA for the treatment of relapsed or refractory CLL/SLL in
Japan, where therapies are extremely limited. We look forward to
supporting Yakult through the clinical development of COPIKTRA in
Japan to help rapidly advance this oral, novel therapy for patients
living with CLL/SLL.”
Verastem and Yakult entered into an exclusive licensing
agreement in June 2018 for Yakult to develop and commercialize
COPIKTRA for the treatment, prevention or diagnosis of all oncology
indications in Japan. Yakult’s Phase 1b, multicenter, open-label
study is expected to enroll approximately 10 patients with relapsed
or refractory CLL/SLL after at least one prior therapy. The primary
endpoint of the study is objective response rate. Secondary
endpoints of the study include overall survival, progression free
survival and safety. This Phase 1b study is expected to serve as a
bridging study based on the efficacy and safety observed in
Verastem Oncology’s Phase 3 DUO study. The results of the Phase 1b
bridging study are expected to form the basis of a regulatory
submission for COPIKTRA for the treatment of relapsed or refractory
CLL/SLL in Japan.
COPIKTRA was approved in September 2018 by the U.S. Food and
Drug Administration (FDA) for the treatment of adult patients with
relapsed or refractory CLL/SLL after at least two prior therapies.
In addition, COPIKTRA has been granted accelerated approval by the
FDA for the treatment of adult patients with relapsed or refractory
follicular lymphoma (FL) after at least two prior systemic
therapies. Accelerated approval in FL was based on overall response
rate and continued approval may be contingent upon verification and
description of clinical benefit in confirmatory trials.
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 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.
SELECT IMPORTANT SAFETY INFORMATION
This does not include all information needed to use COPIKTRA™
(duvelisib) safety 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% 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% of
COPIKTRA-treated patients. Monitor for the development of severe
diarrhea or colitis. Withhold COPIKTRA.
- Fatal and/or serious cutaneous reactions occurred in 5% of
COPIKTRA-treated patients. Withhold COPIKTRA.
- Fatal and/or serious pneumonitis occurred in 5% of
COPIKTRA-treated patients. Monitor for pulmonary symptoms and
interstitial infiltrates. Withhold COPIKTRA.
INDICATIONS AND USAGE
COPIKTRA is a kinase inhibitor 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.
- Relapsed or refractory follicular lymphoma (FL) after at least
two prior systemic therapies. Accelerated approval based on overall
response rate and continued approval may be contingent upon
confirmatory trials
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 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 the possibility of unfavorable results from clinical
trials evaluating COPIKTRA (duvelisib) for the treatment CLL/SLL.
Verastem and/or Yakult may also be unable to enroll patients in
future studies in Japan and may need to modify or delay these
studies or perform additional studies. Ultimately, Verastem and/or
Yakult may fail to secure regulatory approval for COPIKTRA
(duvelisib) in that region. 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20191007005217/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
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