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 CSPC Pharmaceutical Group Limited (HKEx: 1093) (CSPC), a
leading pharmaceutical company in China, has dosed the first
patient in a pivotal Chinese bridging study evaluating COPIKTRA®
(duvelisib) in patients with relapsed or refractory follicular
lymphoma (FL). 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.
“Building on CSPC’s strong track record of successfully
developing and commercializing oncology products in China, we are
pleased that this CSPC trial is now underway as they work to
provide a new option for patients with follicular lymphoma in
China, where there are limited options for this difficult to treat
disease,” said Brian Stuglik, Chief Executive Officer of Verastem
Oncology. “The first patient dosed in this trial is a critical step
in our mission to bring COPIKTRA to patients around the world.”
In September of 2018, Verastem Oncology and CSPC entered into an
exclusive licensing agreement for CSPC to develop and commercialize
Verastem Oncology’s COPIKTRA for the treatment of all oncology
indications in China. CSPC’s single-arm, open-label, multi-center
pivotal study is designed to evaluate the antitumor activity and
safety of duvelisib administered to patients diagnosed with
relapsed or refractory follicular lymphoma. This study is expected
to serve as a bridging study based on the efficacy and safety
observed in Verastem Oncology’s Phase 2 DYNAMO study. The results
of this study will form the basis of a regulatory submission for
COPIKTRA for the treatment of relapsed or refractory FL in
China.
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 chronic lymphocytic leukemia/small
lymphocytic lymphoma (CLL/SLL) after at least two prior therapies.
COPIKTRA also received accelerated approval for the treatment of
adult patients with relapsed or refractory follicular lymphoma (FL)
after at least two prior systemic therapies. Continued approval in
FL 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, in the United States. 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 in the United
States 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 in the United States,
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% (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.
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 CSPC Pharmaceutical Group Limited
CSPC Pharmaceutical Group Limited is a leading pharmaceutical
group in China. The Company has been listed on the Main Board of
the Hong Kong Stock Exchange since 1994 and is currently a
constituent stock of Hang Sang Index. CSPC is a leading developer
and manufacturer of innovative and generic drugs in China.
Blockbuster innovative products in CSPC’s pipeline include NBP
(butylphthalide), OULAINING (oxiracetam), XUANNING (maleate
levamlodipine), DUOMEISU, JINYOULI and KEAILI. CSPC is also a major
manufacturer of bulk drugs, including vitamin C, antibiotics and
caffeine. The production facilities of CSPC are mainly located in
Shijiazhuang City, Hebei Province, China. For more information,
please visit its website at http://www.cspc.com.hk.
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;
whether and when any applications for COPIKTRA 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 COPIKTRA, 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 COPIKTRA
will be commercially successful in such jurisdictions; that we or
CSPC will fail to fully perform under the duvelisib license
agreement; 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 September 30, 2019, as filed
with the Securities and Exchange Commission (SEC) on October 30,
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/20200129005392/en/
Verastem Oncology: 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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