Regulatory News:
Ipsen (Euronext: IPN; ADR: IPSEY) and its partner Exelixis
(NASDAQ: EXEL) today announced that its global phase 3 CELESTIAL
trial met its primary endpoint of overall survival (OS), with
cabozantinib providing a statistically significant and clinically
meaningful improvement in median OS compared to placebo in patients
with advanced hepatocellular carcinoma (HCC). The independent data
monitoring committee for the study recommended that the trial
should be stopped for efficacy following review of the second
planned interim analysis. CELESTIAL is a randomized, global phase 3
trial of cabozantinib versus placebo in patients with advanced HCC
who have been previously treated with sorafenib. The safety data in
the study were consistent with the established profile of
cabozantinib.
In line with and in collaboration with our partner Exelixis,
Ipsen expects to file in the first half of 2018 a variation of the
initial application to the EMA and other relevant regulatory
agencies and to evaluate potential next steps in the
development strategy for cabozantinib outside the United States and
Japan as a treatment for advanced HCC in patients who have been
previously treated. Detailed results from CELESTIAL will be
submitted for presentation at a future medical conference.
Alexandre Lebeaut, MD, Executive Vice-President, R&D,
Chief Scientific Officer, Ipsen, said: “Liver cancer is one of
the leading causes of cancer deaths worldwide and more effective
treatment options are urgently needed. We are pleased to report
that in the CELESTIAL clinical study cabozantinib has been shown to
provide a survival benefit and therefore has the potential to bring
a new oral systemic treatment to previously treated patients with
advanced liver cancer. ”
About the CELESTIAL Study
CELESTIAL is a randomized, double-blind, placebo-controlled
study of cabozantinib in patients with advanced HCC conducted at
more than 100 sites globally in 19 countries. The trial was
designed to enroll 760 patients with advanced HCC who previously
received sorafenib and may have received up to two prior systemic
cancer therapies for HCC and had adequate liver function.
Enrollment of the trial was completed in September 2017, and 773
patients were ultimately randomized. Patients were randomized 2:1
to receive 60 mg of cabozantinib once daily or placebo and were
stratified based on etiology of the disease (hepatitis C, hepatitis
B or other), geographic region (Asia versus other regions) and
presence of extrahepatic spread and/or macrovascular invasion (yes
or no). No cross-over was allowed between the study arms.
The primary endpoint for the trial is OS, and secondary
endpoints include objective response rate and progression-free
survival. Exploratory endpoints include patient-reported outcomes,
biomarkers and safety.
Based on available clinical trial data from various published
trials conducted in the second-line setting of advanced HCC, the
CELESTIAL trial statistics for the primary endpoint of OS assumed a
median OS of 8.2 months for the placebo arm. A total of 621 events
provide the study with 90 percent power to detect a 32 percent
increase in median OS (HR = 0.76) at the final analysis. Two
interim analyses were planned and conducted at 50 percent and 75
percent of the planned 621 events.
About HCCHepatocellular Carcinoma (HCC) is the most
common form of liver cancer in adults.1 The disease originates in
cells called hepatocytes found in the liver. With approximately
800’000 new cases diagnosed each year, HCC is the sixth most common
cancer and the second-leading cause of cancer deaths worldwide.2,3
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 the
disease in advanced stage usually survive between 4 and 8
months.5
About CABOMETYX® (cabozantinib)Cabometyx® is an
oral small molecule inhibitor of receptors, including VEGFR, MET,
AXL and RET. In preclinical models, cabozantinib has been shown to
inhibit the activity of these receptors, which are involved in
normal cellular function and pathologic processes such as tumor
angiogenesis, invasiveness, metastasis and drug resistance.
In February of 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. This agreement was amended in December of
2016 to include commercialization rights for Ipsen in Canada. On
April 25, 2016, the FDA approved Cabometyx® tablets for the
treatment of patients with advanced RCC who have received prior
anti-angiogenic therapy and on September 9, 2016, the European
Commission approved Cabometyx® tablets for the treatment of
advanced RCC in adults who have received prior vascular endothelial
growth factor (VEGF)-targeted therapy in the European Union, Norway
and Iceland. Cabometyx® is available in 20 mg, 40 mg or 60 mg
doses. The recommended dose is 60 mg orally, once daily.
Ipsen also submitted to European Medicines Agency (EMA) the
regulatory dossier for cabozantinib as a treatment for first-line
advanced RCC in the European Union on August 28, 2017; on September
8, 2017, Ipsen announced that the EMA validated the
application.
Cabozantinib is not approved for the treatment of advanced
hepatocellular carcinoma.
About Ipsen
Ipsen is a global specialty-driven biopharmaceutical group
focused on innovation and specialty care. The group develops and
commercializes innovative medicines in three key therapeutic areas
- Oncology, Neurosciences 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 close to €1.6
billion in 2016, 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, and centers located in the
heart of leading biotechnological and life sciences hubs
(Paris-Saclay, France; Oxford, UK; Cambridge, US). The Group has
about 5,100 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.
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 2016 Registration
Document available on its website (www.ipsen.com).
References
1. McGlynn KA, London WT. The Global
Epidemiology of Hepatocellular Carcinoma, Present and Future.
Clinics in liver disease. 2011;15(2):223-x.
doi:10.1016/j.cld.2011.03.006.2. Ferlay J, Soerjomataram I, Dikshit
R, et al: Cancer incidence and mortality worldwide: sources,
methods and major patterns in GLOBOCAN 2012. Int J Cancer
136:E359-86, 20153. GLOBOCAN International Agency for Research on
Cancer (IARC). Available at:
http://gco.iarc.fr/today/fact-sheets-cancers?cancer=7&type=0&sex=04.
GLOBOCAN International Agency for Research on Cancer (IARC).
Available at: http://globocan.iarc.fr/Pages/burden_sel.aspx5.
Annals of Oncology 23 (Supplement 7): vii41–vii48, 2012
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IpsenMediaIan Weatherhead, Tél.: +44 (0)
7584230549Vice-President, Corporate External communicationsE-mail:
ian.weatherhead@ipsen.comorBrigitte Le Guennec, Tel.: +33
(0)1 58 33 51 17Corporate External Communication ManagerE-mail :
brigitte.le.guennec@ipsen.comorFinancial
CommunityEugenia Litz, Tel.: +44 (0) 1753
627721Vice-President Investor RelationsE-mail:
eugenia.litz@ipsen.comorCôme de La Tour du Pin, Tel.: +33
(0)1 58 33 53 31Investor Relations ManagerE-mail:
come.de.la.tour.du.pin@ipsen.com
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