– Clinical trial will also explore
single-agent activity of cabozantinib in the first-line setting
–
Exelixis, Inc. (Nasdaq:EXEL) and Ipsen (Euronext:IPN;
ADR:IPSEY) today announced the initiation of COSMIC-312, a
phase 3 pivotal trial of cabozantinib (CABOMETYX®) in combination
with atezolizumab (TECENTRIQ®) versus sorafenib in previously
untreated advanced hepatocellular carcinoma (HCC). The co-primary
endpoints of the trial are progression-free survival and overall
survival. An exploratory arm will also evaluate cabozantinib
monotherapy in this first-line setting.
“Liver cancer is the fastest-rising cause of cancer-related
death in the U.S., underscoring the need for new treatment options
for this patient community,” said Gisela Schwab, M.D., President,
Product Development and Medical Affairs and Chief Medical Officer,
Exelixis. “Based on past evidence of potential synergistic effects
with cabozantinib and immune checkpoint inhibitors, the combination
offers promise for patients with advanced liver cancer who have not
received prior treatment.”
COSMIC-312 is a multicenter, randomized, controlled phase 3
pivotal trial that aims to enroll approximately 640 patients at up
to 200 sites globally. Patients will be randomized 6:3:1 to one of
three arms: cabozantinib (40 mg) and atezolizumab, sorafenib, or
cabozantinib (60 mg).
Exelixis is sponsoring COSMIC-312, and Ipsen will co-fund the
trial. Ipsen will have access to the results to support potential
future regulatory submissions outside of the U.S. and Japan.
Genentech, a member of the Roche Group, is providing atezolizumab
for use in this trial.
“With more than 800,000 new diagnoses of liver cancer worldwide
each year and a poor prognosis for patients with advanced disease,
there is an urgent need to identify new treatment options,” said R.
Kate Kelley, M.D., Associate Professor of Clinical Medicine,
Division of Hematology/Oncology, University of California, San
Francisco, and lead investigator on COSMIC-312. “We look forward to
learning whether the combination of cabozantinib and atezolizumab
may improve outcomes for previously untreated patients.”
More information about this trial is available at
ClinicalTrials.gov.
About HCC
Liver cancer is the second-leading cause of cancer death
worldwide, accounting for more than 700,000 deaths and 800,000 new
cases each year.1 In the U.S., the incidence of liver cancer has
more than tripled since 1980.2 HCC is the most common form of liver
cancer, making up about three-fourths of the estimated nearly
42,000 new cases in the U.S. in 2018.2 HCC is the fastest-rising
cause of cancer-related death in the U.S.3 According to the
GLOBOCAN data, it is estimated that across the European Union
(EU-28) nearly 60,000 new patients will be diagnosed with liver
cancer in 2020.4 Without treatment, patients with advanced HCC
usually survive less than 6 months.5
About CABOMETYX® (cabozantinib)
CABOMETYX tablets are approved in the United States for the
treatment of patients with renal cell carcinoma (RCC). On May 29,
2018, Exelixis announced that the U.S. Food and Drug Administration
(FDA) accepted for filing the supplemental New Drug Application for
CABOMETYX for previously treated advanced HCC and assigned a
Prescription Drug User Fee Act action date of January 14, 2019. In
March 2017, the FDA granted orphan drug designation to cabozantinib
for the treatment of advanced HCC.
CABOMETYX tablets are also approved in: the European Union,
Norway, Iceland, Australia, Switzerland, South Korea, Canada,
Brazil and Taiwan for the treatment of advanced RCC in adults who
have received prior VEGF-targeted therapy; in the European Union
for previously untreated intermediate- or poor-risk advanced RCC;
in Canada for adult patients with advanced RCC who have received
prior VEGF targeted therapy; and in the European Union, Norway and
Iceland for HCC in adults who have previously been treated with
sorafenib.
CABOMETYX is not indicated for previously untreated advanced
HCC.
About Exelixis’ Collaboration with Ipsen
On February 29, 2016, Exelixis and Ipsen jointly announced an
exclusive licensing agreement for the commercialization and further
development of cabozantinib indications outside of the United
States, Canada and Japan. On December 21, 2016, this agreement was
amended to include commercialization rights for Ipsen in Canada.
Ipsen has opted to participate in this phase 3 trial in first-line
advanced HCC and will have access to the results to support
potential future regulatory submissions. They may also participate
in future studies at their choosing.
About Exelixis’ Collaboration with Takeda
On January 30, 2017, Exelixis and Takeda jointly announced an
exclusive licensing agreement for the commercialization and further
development of cabozantinib indications in Japan. Under the
parties’ collaboration agreement, if Takeda opts to participate in
funding this phase 3 trial, or future studies, Takeda will have
access to the respective study results to support potential future
regulatory submissions in their territory.
Exelixis holds the exclusive rights to develop and commercialize
cabozantinib in the United States.
Please see Important Safety Information below and full U.S.
prescribing information
athttps://cabometyx.com/downloads/CABOMETYXUSPI.pdf.
U.S. Important Safety Information
- Hemorrhage: Severe and fatal
hemorrhages have occurred with CABOMETYX. In two RCC studies, the
incidence of Grade ≥ 3 hemorrhagic events was 3% in
CABOMETYX-treated patients. Do not administer CABOMETYX to patients
that have or are at risk for severe hemorrhage.
- Gastrointestinal (GI) Perforations
and Fistulas: In RCC studies, fistulas were reported in 1% of
CABOMETYX-treated patients. Fatal perforations occurred in patients
treated with CABOMETYX. In RCC studies, gastrointestinal (GI)
perforations were reported in 1% of CABOMETYX-treated patients.
Monitor patients for symptoms of fistulas and perforations,
including abscess and sepsis. Discontinue CABOMETYX in patients who
experience a fistula which cannot be appropriately managed or a GI
perforation.
- Thrombotic Events: CABOMETYX
treatment results in an increased incidence of thrombotic events.
In RCC studies, venous thromboembolism occurred in 9% (including 5%
pulmonary embolism) and arterial thromboembolism occurred in 1% of
CABOMETYX-treated patients. Fatal thrombotic events occurred in the
cabozantinib clinical program. Discontinue CABOMETYX in patients
who develop an acute myocardial infarction or any other arterial
thromboembolic complication.
- Hypertension and Hypertensive
Crisis: CABOMETYX treatment results in an increased incidence
of treatment-emergent hypertension, including hypertensive crisis.
In RCC studies, hypertension was reported in 44% (18% Grade
≥ 3) of CABOMETYX-treated patients. Monitor blood pressure
prior to initiation and regularly during CABOMETYX treatment.
Withhold CABOMETYX for hypertension that is not adequately
controlled with medical management; when controlled, resume
CABOMETYX at a reduced dose. Discontinue CABOMETYX for severe
hypertension that cannot be controlled with anti-hypertensive
therapy. Discontinue CABOMETYX if there is evidence of hypertensive
crisis or severe hypertension despite optimal medical
management.
- Diarrhea: In RCC studies,
diarrhea occurred in 74% of patients treated with CABOMETYX.
Grade 3 diarrhea occurred in 11% of patients treated with
CABOMETYX. Withhold CABOMETYX in patients who develop intolerable
Grade 2 diarrhea or Grade 3-4 diarrhea that cannot be managed with
standard antidiarrheal treatments until improvement to Grade 1;
resume CABOMETYX at a reduced dose.
- Palmar-Plantar Erythrodysesthesia
(PPE): In RCC studies, palmar-plantar erythrodysesthesia (PPE)
occurred in 42% of patients treated with CABOMETYX. Grade 3 PPE
occurred in 8% of patients treated with CABOMETYX. Withhold
CABOMETYX in patients who develop intolerable Grade 2 PPE or Grade
3 PPE until improvement to Grade 1; resume CABOMETYX at a reduced
dose.
- Reversible Posterior
Leukoencephalopathy Syndrome (RPLS), a syndrome of subcortical
vasogenic edema diagnosed by characteristic finding on MRI,
occurred in the cabozantinib clinical program. Perform an
evaluation for RPLS in any patient presenting with seizures,
headache, visual disturbances, confusion or altered mental
function. Discontinue CABOMETYX in patients who develop RPLS.
- Embryo-fetal Toxicity may be
associated with CABOMETYX. Advise pregnant women of the potential
risk to a fetus. Advise females of reproductive potential to use
effective contraception during CABOMETYX treatment and for 4 months
after the last dose.
- Adverse Reactions: The most
commonly reported (≥25%) adverse reactions are: diarrhea, fatigue,
nausea, decreased appetite, hypertension, PPE, weight decreased,
vomiting, dysgeusia, and stomatitis.
- Strong CYP3A4 Inhibitors: If
concomitant use with strong CYP3A4 inhibitors cannot be avoided,
reduce the CABOMETYX dosage.
- Strong CYP3A4 Inducers: If
concomitant use with strong CYP3A4 inducers cannot be avoided,
increase the CABOMETYX dosage.
- Lactation: Advise women not to
breastfeed while taking CABOMETYX and for 4 months after the final
dose.
- Hepatic Impairment: In patients
with mild to 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 genetic systems, 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. We discovered our three commercially available products,
CABOMETYX® (cabozantinib), COMETRIQ® (cabozantinib) and COTELLIC®
(cobimetinib), and 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 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.
About Ipsen
Ipsen is a global biopharmaceutical group focused on innovation
and specialty care. The group develops and commercializes
innovative medicines in three key therapeutic areas - Oncology,
Neuroscience and Rare Diseases. Its commitment to Oncology is
exemplified through its growing portfolio of key therapies for
prostate cancer, neuroendocrine tumors, renal cell carcinoma and
pancreatic cancer. Ipsen also has a well-established Consumer
Healthcare business. With total sales over €1.9 billion in 2017,
Ipsen sells more than 20 drugs in over 115 countries, with a direct
commercial presence in more than 30 countries. Ipsen's R&D is
focused on its innovative and differentiated technological
platforms located in the heart of the leading biotechnological and
life sciences hubs (Paris-Saclay, France; Oxford, UK; Cambridge,
US). The Group has about 5,400 employees worldwide. Ipsen is listed
in Paris (Euronext: IPN) and in the United States through a
Sponsored Level I American Depositary Receipt program (ADR: IPSEY).
For more information on Ipsen, visit www.ipsen.com.
Exelixis Forward-Looking Statements
This press release contains forward-looking statements,
including, without limitation, statements related to: the potential
of the combination of cabozantinib and atezolizumab, or of
cabozantinib as a monotherapy, as treatment options for patients
with previously untreated advanced HCC; 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 the combination of
cabozantinib and atezolizumab, or of cabozantinib as a monotherapy,
to demonstrate safety and/or efficacy in COSMIC-312; 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, including the
ability or willingness of Exelixis’ collaboration partners to
invest in the resources necessary to complete the 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; 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 November 1,
2018, and in Exelixis’ future filings with the SEC. 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.
Ipsen Forward-Looking Statement
The forward-looking statements, objectives and targets contained
herein are based on the Group’s management strategy, current views
and assumptions. Such statements involve known and unknown risks
and uncertainties that may cause actual results, performance or
events to differ materially from those anticipated herein. All of
the above risks could affect the Group’s future ability to achieve
its financial targets, which were set assuming reasonable
macroeconomic conditions based on the information available today.
Use of the words "believes", "anticipates" and "expects" and
similar expressions are intended to identify forward-looking
statements, including the Group’s expectations regarding future
events, including regulatory filings and determinations. Moreover,
the targets described in this document were prepared without taking
into account external growth assumptions and potential future
acquisitions, which may alter these parameters. These objectives
are based on data and assumptions regarded as reasonable by the
Group. These targets depend on conditions or facts likely to happen
in the future, and not exclusively on historical data. Actual
results may depart significantly from these targets given the
occurrence of certain risks and uncertainties, notably the fact
that a promising product in early development phase or clinical
trial may end up never being launched on the market or reaching its
commercial targets, notably for regulatory or competition reasons.
The Group must face or might face competition from generic products
that might translate into a loss of market share. Furthermore, the
Research and Development process involves several stages each of
which involves the substantial risk that the Group may fail to
achieve its objectives and be forced to abandon its efforts with
regards to a product in which it has invested significant sums.
Therefore, the Group cannot be certain that favorable results
obtained during pre-clinical trials will be confirmed subsequently
during clinical trials, or that the results of clinical trials will
be sufficient to demonstrate the safe and effective nature of the
product concerned. There can be no guarantees a product will
receive the necessary regulatory approvals or that the product will
prove to be commercially successful. If underlying assumptions
prove inaccurate or risks or uncertainties materialize, actual
results may differ materially from those set forth in the
forward-looking statements. Other risks and uncertainties include
but are not limited to, general industry conditions and
competition; general economic factors, including interest rate and
currency exchange rate fluctuations; the impact of pharmaceutical
industry regulation and health care legislation; global trends
toward health care cost containment; technological advances, new
products and patents attained by competitors; challenges inherent
in new product development, including obtaining regulatory
approval; the Group's ability to accurately predict future market
conditions; manufacturing difficulties or delays; financial
instability of international economies and sovereign risk;
dependence on the effectiveness of the Group’s patents and other
protections for innovative products; and the exposure to
litigation, including patent litigation, and/or regulatory actions.
The Group also depends on third parties to develop and market some
of its products which could potentially generate substantial
royalties; these partners could behave in such ways which could
cause damage to the Group’s activities and financial results. The
Group cannot be certain that its partners will fulfil their
obligations. It might be unable to obtain any benefit from those
agreements. A default by any of the Group’s partners could generate
lower revenues than expected. Such situations could have a negative
impact on the Group’s business, financial position or performance.
The Group expressly disclaims any obligation or undertaking to
update or revise any forward-looking statements, targets or
estimates contained in this press release to reflect any change in
events, conditions, assumptions or circumstances on which any such
statements are based, unless so required by applicable law. The
Group’s business is subject to the risk factors outlined in its
registration documents filed with the French Autorité des Marchés
Financiers. The risks and uncertainties set out are not exhaustive
and the reader is advised to refer to the Group’s 2017 Registration
Document available on its website (www.ipsen.com).
Exelixis, the Exelixis logo, CABOMETYX,
COMETRIQ and COTELLIC are registered U.S. trademarks.
TECENTRIQ® (atezolizumab) is a registered
trademark of Genentech, a member of the Roche Group.
The information stated above was prepared by
Exelixis Inc. and Ipsen and reflects solely the opinion of Exelixis
and Ipsen. Nothing in this statement shall be construed to imply
any support or endorsement of Exelixis or Ipsen, or any of its
products, by the Regents of the University of California, its
officers, agents and employees.
1 International Agency for Research on Cancer. GLOBOCAN 2018.
Liver Fact Sheet. Available
at: http://gco.iarc.fr/today/data/factsheets/cancers/11-Liver-fact-sheet.pdf. Accessed
November 2018.2 American Cancer Society: Cancer Facts and Figures
2018. Available at:
https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2018/cancer-facts-and-figures-2018.pdf.
Accessed November 2018.3 Mittal S, El-Serag HB. Epidemiology of
HCC: Consider the Population. Journal of Clinical Gastroenterology.
2013. 47:S2-S6.4 GLOBOCAN International Agency for Research on
Cancer (IARC). Cancer Tomorrow. Accessed November 2018:
http://globocan.iarc.fr/Pages/burden_sel.aspx5 Weledji E, Orock G,
Ngowe M, NsaghaD. How grim is hepatocellular carcinoma? Annals of
Medicine and Surgery. 2014. 3:71-76.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20181204006141/en/
Investors:Susan HubbardEVP, Public Affairs andInvestor
RelationsExelixis, Inc.(650) 837-8194shubbard@exelixis.com
Media:Lindsay TreadwaySenior Director, Public Affairsand
Advocacy RelationsExelixis, Inc.(650)
837-7522ltreadway@exelixis.com
Investors:Eugenia LitzVice President, Investor
RelationsIpsen+44 (0) 1753 627721eugenia.litz@ipsen.com
Media:Ian WeatherheadVice President, Corporate External
CommunicationsIpsen+44 (0) 1753 627733ian.weatherhead@ipsen.com
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