– Analysis for the co-primary endpoint of
objective response rate and an interim analysis of progression-free
survival expected in the second half of 2020 –
Exelixis, Inc. (NASDAQ: EXEL) today announced enrollment of the
first 100 patients in COSMIC-311, a phase 3 pivotal trial
evaluating cabozantinib (CABOMETYX®) versus placebo in patients
with radioactive iodine-refractory differentiated thyroid cancer
who have progressed after up to two vascular endothelial growth
factor (VEGF) receptor-targeted therapies.
“Given the encouraging clinical activity observed for
cabozantinib in phase 1 and 2 trials in differentiated thyroid
cancer, and the poor prognosis for patients who have progressed
after prior VEGF receptor-targeting therapy, it is exciting to
reach this milestone for COSMIC-311,” said Gisela Schwab, M.D.,
President, Product Development and Medical Affairs and Chief
Medical Officer, Exelixis. “This brings us one step closer to a
first analysis that will help us better understand cabozantinib’s
potential in treating patients with this intractable form of
thyroid cancer. We look forward to sharing those initial results
later this year.”
COSMIC-311 is a multicenter, randomized, double-blind,
placebo-controlled phase 3 pivotal trial that aims to enroll
approximately 300 patients at 150 sites globally. Patients will be
randomized in a 2:1 ratio to receive either cabozantinib 60 mg or
placebo once daily. Exelixis expects to conduct an analysis in the
first 100 patients for the co-primary endpoint of objective
response rate, and an interim analysis of progression-free survival
in the second half of 2020. Additionally, total enrollment of 300
patients is expected to be reached in the second half of 2020.
More information about this trial is available at
ClinicalTrials.gov.
About Differentiated Thyroid Cancer
Approximately 53,000 new cases of thyroid cancer will be
diagnosed in the U.S. in 2020.1 Nearly three out of four of these
cases will be in women, and the disease is more commonly diagnosed
at a younger age compared to most other adult cancers.1 While
cancerous thyroid tumors include differentiated, medullary and
anaplastic forms, differentiated thyroid tumors make up about 90
percent of cases.1 These include papillary, follicular and Hürthle
cell cancer.1 Differentiated thyroid cancer is typically treated
with surgery followed by ablation of the remaining thyroid with
radioiodine, but approximately 5% to 15% of cases are resistant to
radioiodine treatment. 2,3 For these patients, life expectancy is
only three to six years from the time metastatic lesions are
detected.4,5,6
About CABOMETYX® (cabozantinib)
In the U.S., CABOMETYX tablets are approved for the treatment of
patients with advanced RCC and for the treatment of patients with
HCC who have been previously treated with sorafenib. CABOMETYX
tablets have also received regulatory approvals in the European
Union and additional countries and regions worldwide. In 2016,
Exelixis granted Ipsen exclusive rights for the commercialization
and further clinical development of cabozantinib outside of the
United States and Japan. In 2017, Exelixis granted exclusive rights
to Takeda Pharmaceutical Company Limited for the commercialization
and further clinical development of cabozantinib for all future
indications in Japan.
CABOMETYX is not indicated for radioiodine-refractory
differentiated thyroid cancer.
Important Safety Information
Warnings and Precautions
Hemorrhage: Severe and fatal hemorrhages occurred with
CABOMETYX. The incidence of Grade 3 to 5 hemorrhagic events was 5%
in CABOMETYX patients in RCC and HCC studies. Discontinue CABOMETYX
for Grade 3 or 4 hemorrhage. Do not administer CABOMETYX to
patients who have a recent history of hemorrhage, including
hemoptysis, hematemesis, or melena.
Perforations and Fistulas: Gastrointestinal (GI)
perforations, including fatal cases, occurred in 1% of CABOMETYX
patients. Fistulas, including fatal cases, occurred in 1% of
CABOMETYX patients. Monitor patients for signs and symptoms of
perforations and fistulas, including abscess and sepsis.
Discontinue CABOMETYX in patients who experience a Grade 4 fistula
or a GI perforation.
Thrombotic Events: CABOMETYX increased the risk of
thrombotic events. Venous thromboembolism occurred in 7% (including
4% pulmonary embolism) and arterial thromboembolism in 2% of
CABOMETYX patients. Fatal thrombotic events occurred in CABOMETYX
patients. Discontinue CABOMETYX in patients who develop an acute
myocardial infarction or serious arterial or venous thromboembolic
event requiring medical intervention.
Hypertension and Hypertensive Crisis: CABOMETYX can cause
hypertension, including hypertensive crisis. Hypertension occurred
in 36% (17% Grade 3 and <1% Grade 4) of CABOMETYX patients. Do
not initiate CABOMETYX in patients with uncontrolled hypertension.
Monitor blood pressure regularly during CABOMETYX treatment.
Withhold CABOMETYX for hypertension that is not adequately
controlled with medical management; when controlled, resume at a
reduced dose. Discontinue CABOMETYX for severe hypertension that
cannot be controlled with anti-hypertensive therapy or for
hypertensive crisis.
Diarrhea: Diarrhea occurred in 63% of CABOMETYX patients.
Grade 3 diarrhea occurred in 11% of CABOMETYX patients. Withhold
CABOMETYX until improvement to Grade 1 and resume at a reduced dose
for intolerable Grade 2 diarrhea, Grade 3 diarrhea that cannot be
managed with standard antidiarrheal treatments, or Grade 4
diarrhea.
Palmar-Plantar Erythrodysesthesia (PPE): PPE occurred in
44% of CABOMETYX patients. Grade 3 PPE occurred in 13% of CABOMETYX
patients. Withhold CABOMETYX until improvement to Grade 1 and
resume at a reduced dose for intolerable Grade 2 PPE or Grade 3
PPE.
Proteinuria: Proteinuria occurred in 7% of CABOMETYX
patients. Monitor urine protein regularly during CABOMETYX
treatment. Discontinue CABOMETYX in patients who develop nephrotic
syndrome.
Osteonecrosis of the Jaw (ONJ): ONJ occurred in <1% of
CABOMETYX patients. ONJ can manifest as jaw pain, osteomyelitis,
osteitis, bone erosion, tooth or periodontal infection, toothache,
gingival ulceration or erosion, persistent jaw pain, or slow
healing of the mouth or jaw after dental surgery. Perform an oral
examination prior to CABOMETYX initiation and periodically during
treatment. Advise patients regarding good oral hygiene practices.
Withhold CABOMETYX for at least 3 weeks prior to scheduled dental
surgery or invasive dental procedures, if possible. Withhold
CABOMETYX for development of ONJ until complete resolution.
Impaired Wound Healing: Wound complications occurred with
CABOMETYX. Withhold CABOMETYX for at least 3 weeks prior to
elective surgery. Do not administer CABOMETYX for at least 2 weeks
after major surgery and until adequate wound healing is observed.
The safety of resumption of CABOMETYX after resolution of wound
healing complications has not been established.
Reversible Posterior Leukoencephalopathy Syndrome (RPLS):
RPLS, a syndrome of subcortical vasogenic edema diagnosed by
characteristic findings on MRI, can occur with CABOMETYX. Evaluate
for RPLS in patients presenting with seizures, headache, visual
disturbances, confusion, or altered mental function. Discontinue
CABOMETYX in patients who develop RPLS.
Embryo-Fetal Toxicity: CABOMETYX can cause fetal harm.
Advise pregnant women and females of reproductive potential of the
potential risk to a fetus. Verify the pregnancy status of females
of reproductive potential prior to initiating CABOMETYX and advise
them to use effective contraception during treatment and for 4
months after the last dose.
Adverse Reactions
The most commonly reported (≥25%) adverse reactions are:
diarrhea, fatigue, decreased appetite, PPE, nausea, hypertension,
and vomiting.
Drug Interactions
Strong CYP3A4 Inhibitors: If coadministration with strong
CYP3A4 inhibitors cannot be avoided, reduce the CABOMETYX dosage.
Avoid grapefruit or grapefruit juice.
Strong CYP3A4 Inducers: If coadministration with strong
CYP3A4 inducers cannot be avoided, increase the CABOMETYX dosage.
Avoid St. John’s wort.
USE IN SPECIFIC POPULATIONS
Lactation: Advise women not to breastfeed during
CABOMETYX treatment and for 4 months after the final dose.
Hepatic Impairment: In patients with moderate hepatic
impairment, reduce the CABOMETYX dosage. CABOMETYX is not
recommended for use in patients with severe hepatic impairment.
Please see accompanying full Prescribing Information:
https://cabometyx.com/downloads/CABOMETYXUSPI.pdf.
About Exelixis
Founded in 1994, Exelixis, Inc. (NASDAQ: EXEL) is a commercially
successful, oncology-focused biotechnology company that strives to
accelerate the discovery, development and commercialization of new
medicines for difficult-to-treat cancers. Following early work in
model system genetics, we established a broad drug discovery and
development platform that has served as the foundation for our
continued efforts to bring new cancer therapies to patients in
need. Our discovery efforts have resulted in four commercially
available products, CABOMETYX® (cabozantinib), COMETRIQ®
(cabozantinib), COTELLIC® (cobimetinib) and MINNEBRO®
(esaxerenone), and we have entered into partnerships with leading
pharmaceutical companies to bring these important medicines to
patients worldwide. Supported by revenues from our marketed
products and collaborations, we are committed to prudently
reinvesting in our business to maximize the potential of our
pipeline. We are supplementing our existing therapeutic assets with
targeted business development activities and internal drug
discovery — all to deliver the next generation of Exelixis
medicines and help patients recover stronger and live longer.
Exelixis is a member of the Standard & Poor’s (S&P) MidCap
400 index, which measures the performance of profitable mid-sized
companies. For more information about Exelixis, please visit
www.exelixis.com, follow @ExelixisInc on Twitter or like Exelixis,
Inc. on Facebook.
Forward-Looking Statements
This press release contains forward-looking statements,
including, without limitation, statements related to: the
therapeutic potential of cabozantinib as a treatment for patients
with radioactive iodine-refractory differentiated thyroid cancer;
Exelixis’ plans to conduct an analysis in the first 100 patients
enrolled in COSMIC-311 for the co-primary endpoint of objective
response rate, and an interim analysis of progression-free survival
in the second half of 2020; Exelixis’ expectation that total
enrollment of 300 patients in COSMIC-311 will be reached in the
second half of 2020; and Exelixis’ plans to reinvest in its
business to maximize the potential of the company’s pipeline,
including through targeted business development activities and
internal drug discovery. Any statements that refer to expectations,
projections or other characterizations of future events or
circumstances are forward-looking statements and are based upon
Exelixis’ current plans, assumptions, beliefs, expectations,
estimates and projections. Forward-looking statements involve risks
and uncertainties. Actual results and the timing of events could
differ materially from those anticipated in the forward-looking
statements as a result of these risks and uncertainties, which
include, without limitation: risks and uncertainties related to
regulatory review and approval processes and Exelixis’ compliance
with applicable legal and regulatory requirements; the potential
failure of cabozantinib to demonstrate safety and/or efficacy in
COSMIC-311; uncertainties inherent in the product development
process, including evolving regulatory requirements, slower than
anticipated patient enrollment or inability to identify a
sufficient number of clinical trial sites; the costs of conducting
clinical trials; Exelixis’ dependence on third-party vendors for
the development, manufacture and supply of cabozantinib; Exelixis’
ability to protect its intellectual property rights; market
competition, including the potential for competitors to obtain
approval for generic versions of CABOMETYX; changes in economic and
business conditions; and other factors affecting Exelixis and its
development programs discussed under the caption “Risk Factors” in
Exelixis’ Quarterly Report on Form 10-Q filed with the Securities
and Exchange Commission (SEC) on October 30, 2019, and in Exelixis’
future filings with the SEC, including, without limitation,
Exelixis’ Annual Report on Form 10-K expected to be filed with the
SEC on February 25, 2020. All forward-looking statements in this
press release are based on information available to Exelixis as of
the date of this press release, and Exelixis undertakes no
obligation to update or revise any forward-looking statements
contained herein.
Exelixis, the Exelixis logo, CABOMETYX,
COMETRIQ and COTELLIC are registered U.S. trademarks. MINNEBRO is a
Japanese trademark.
__________________ 1 American Cancer Society. About Thyroid
Cancer. Available at:
https://www.cancer.org/cancer/thyroid-cancer/about.html. Accessed
February 2020. 2 Cooper DS, et al. 2009. Revised American Thyroid
Association management guidelines for patients with thyroid nodules
and differentiated thyroid cancer: The American Thyroid Association
(ATA) Guidelines Taskforce on Thyroid Nodules and Differentiated
Thyroid Cancer. Thyroid. 19:1167–1214. 3 Worden F. 2014. Treatment
strategies for radioactive iodine-refractory differentiated thyroid
cancer. Ther Adv Med Oncol. 6:267–279. 4 Xing M, Haugen BR,
Schlumberger M. 2013. Progress in molecular-based management of
differentiated thyroid cancer. Lancet. 381:1058–1069. 5 Pacini F,
et al. 2012. Radioactive iodine-refractory differentiated thyroid
cancer: unmet needs and future directions. Expert Rev Endocrinol
Metab. 7:541–554. 6 Durante C, et al. 2006. Long-term outcome of
444 patients with distant metastases from papillary and follicular
thyroid carcinoma: benefits and limits of radioiodine therapy. J
Clin Endocrinol Metab. 91:2892–2899.
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version on businesswire.com: https://www.businesswire.com/news/home/20200225005987/en/
Investors: Susan Hubbard EVP, Public Affairs and Investor
Relations Exelixis, Inc. (650) 837-8194 shubbard@exelixis.com
Media: Lindsay Treadway Senior Director, Public Affairs and
Advocacy Relations Exelixis, Inc. (650) 837-7522
ltreadway@exelixis.com
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