- Recommendation based on the Phase III CheckMate -9ER trial, in
which Cabometyx® (cabozantinib) in combination with Opdivo®
(nivolumab) doubled progression-free survival and significantly
improved overall survival and response rates1
- Cabometyx® in combination with Opdivo® showed consistent
efficacy benefits across key subgroups of patients1
- Patients treated with Cabometyx® in combination with Opdivo®
reported significantly better health-related quality of life and a
lower rate of discontinuation versus sunitinib2,3
Disclaimer: Intended for international media and investor
audiences only
Regulatory News:
Ipsen (Euronext: IPN; ADR: IPSEY) today announced that the
Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) has recommended approval for
Cabometyx® (cabozantinib) in combination with Bristol Myers
Squibb’s Opdivo® (nivolumab) for the first-line treatment of
advanced renal cell carcinoma (aRCC). The European Commission,
which has the authority to approve medicines for the European Union
(E.U.), will now review the CHMP recommendation and a final
decision on the application in the E.U. is expected in the coming
months.
“Advanced renal cell carcinoma is a disease that significantly
impacts the lives of people around the world. We’re proud to be
able to share that the CHMP has confirmed a positive recommendation
for Cabometyx® in combination with Opdivo®, bringing this impactful
new treatment option one step closer for patients,” said Howard
Mayer, Executive Vice President and Head of Research and
Development, Ipsen. “At Ipsen, we are committed to progressing
treatment for cancers which have an urgent need for additional
therapeutic options and this recommendation marks an important
milestone in achieving this.”
The CHMP adopted the positive opinion based on results from the
pivotal Phase III CheckMate -9ER trial, which demonstrated
significant and clinically meaningful improvements in
progression-free survival (PFS), overall survival (OS) and
objective response rate (ORR) compared to sunitinib, with
consistent efficacy benefits observed across key subgroups of
patients.1 Cabometyx® combined with Opdivo® was well tolerated and
reflected the known safety profiles of the immunotherapy and
tyrosine kinase inhibitor (TKI) components in first-line advanced
RCC.1 The full data from the CheckMate -9ER trial were presented
during a Presidential Symposium at the European Society for Medical
Oncology (ESMO) Virtual Congress 2020. At the recent American
Society of Clinical Oncology 2021 Genitourinary Cancers Symposium
(ASCO GU), additional data from the CheckMate -9ER trial were also
presented, highlighting sustained superior efficacy with a longer
duration of follow-up as well as significantly improved
health-related quality of life outcomes for the combination versus
sunitinib.2,3
Ipsen and its partners have shared the CheckMate -9ER data with
regulatory authorities around the world. The combination of
Cabometyx® and Opdivo® was approved by the U.S. Food and Drug
Administration (FDA) as first-line treatment for patients living
with advanced renal cell carcinoma in January 2021.
“Today’s news is welcomed by physicians treating people living
with advanced renal cell carcinoma,” said Dr. Cristina Suárez,
Medical Oncologist at the Vall d´Hebron University Hospital,
Barcelona, Spain, and a lead investigator on the Phase III
CheckMate -9ER trial. “The positive CHMP opinion brings us one step
closer to the promise of a new approach that combines improved
treatment outcomes, a favorable tolerability profile and superior
health-related quality of life for patients.”
About renal cell carcinoma There are over 400,000 new
cases of kidney cancer diagnosed worldwide each year.4 Of these,
renal cell carcinoma (RCC) is the most common type of kidney
cancer, accounting for approximately 90% of cases.5,6 It is twice
as common in men, and male patients account for over two thirds of
deaths.4 If detected in the early stages, the five-year survival
rate is high, but for patients with advanced or late-stage
metastatic RCC the survival rate is much lower, around 12%, with no
identified cure for this disease.7,8
About the CheckMate -9ER trial CheckMate -9ER is an
open-label, randomized, multi-national Phase III trial evaluating
patients with previously untreated advanced or metastatic RCC. A
total of 651 patients (23% favorable risk, 58% intermediate risk,
20% poor risk; 25% PD-L1 ≥1%) were randomized to Cabometyx® plus
Opdivo® (n= 323) versus sunitinib (n= 328). The primary endpoint is
progression-free survival (PFS). Secondary endpoints include
overall survival (OS) and objective response rate (ORR). The
primary efficacy analysis is comparing the doublet combination
versus sunitinib in all randomized patients. The trial is sponsored
by Bristol Myers Squibb and Ono Pharmaceutical Co and co-funded by
Exelixis, Ipsen and Takeda Pharmaceutical Company Limited.
About Cabometyx® (cabozantinib) Cabometyx® is currently
approved in 57 countries, including in the European Union, the
U.K., Norway, Iceland, Australia, New Zealand, Switzerland, South
Korea, Canada, Brazil, Taiwan, Hong-Kong, Singapore, Macau, Jordan,
Lebanon, Russian Federation, Ukraine, Turkey, United Arab Emirates,
Saudi Arabia, Serbia, Israel, Mexico, Chile, Peru, Panama,
Guatemala, Dominican Republic, Ecuador and Thailand for the
treatment of advanced RCC in adults who have received prior
VEGF-targeted therapy; in the European Union, the U.K., Norway,
Iceland, Canada, Australia, Brazil, Taiwan, Hong Kong, Singapore,
Lebanon, Jordan, Russian Federation, Ukraine, Turkey, United Arab
Emirates, Saudi Arabia, Israel, Mexico, Chile, Peru, Panama,
Guatemala, Dominican Republic, Ecuador and Thailand for previously
untreated intermediate- or poor-risk advanced RCC; and in the
European Union, the U.K., Norway, Iceland, Canada, Australia,
Switzerland, Saudi Arabia, Serbia, Israel, Taiwan, Hong Kong, South
Korea, Singapore, Jordan, Russian Federation, Ukraine, Turkey,
Lebanon, United Arab Emirates, Peru, Panama, Guatemala, Chile,
Dominican Republic, Ecuador and Thailand for HCC in adults who have
previously been treated with sorafenib.
The detailed recommendations for the use of Cabometyx® are
described in the Summary of Product Characteristics (SmPC) and in
the U.S. Prescribing Information (PI).
Cabometyx® is marketed by Exelixis, Inc. in the United States
and by Takeda Pharmaceutical Company Limited in Japan. Ipsen has
exclusive rights for the commercialization and further clinical
development of Cabometyx® outside of the U.S. and Japan. Cabometyx®
is a registered trademark of Exelixis, Inc.
About Ipsen Ipsen is a global mid-size biopharmaceutical
company with a focus on transformative medicines in Oncology, Rare
Disease and Neuroscience. Ipsen also has a well-established
Consumer Healthcare business. With total sales over €2.5 billion in
2020, 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; Shanghai, China). The Group has about
5,700 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.fr
Opdivo® is a registered trademark of Bristol-Myers Squibb
Company.
Ipsen—Cautionary Note Regarding Forward-Looking
Statements 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 and also taking into
consideration assessment delays of certain clinical trials in light
of the ongoing COVID-19 pandemic. 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 2018 Registration
Document available on its website (www.ipsen.com).
References
- Choueiri TK et al. Nivolumab + cabozantinib vs sunitinib in
first-line treatment for advanced renal cell carcinoma: First
results from the randomized phase III CheckMate 9ER trial. European
Society for Medical Oncology. 2020; 31:4, DOI:
https://doi.org/10.1016/j.annonc.2020.08.2257
- Motzer et al., ASCO-GU 2021. Nivolumab + cabozantinib
(NIVO+CABO) vs sunitinib (SUN) as first-line therapy for advanced
renal cell carcinoma (aRCC): extended follow-up and outcomes in the
sarcomatoid subgroup of CheckMate -9ER.
- Cella et al., ASCO-GU 2021. Patient-reported outcomes (PROs) of
patients (pts) with advanced renal cell carcinoma (aRCC) treated
with first-line (1L) nivolumab plus cabozantinib (NIVO+CABO) vs
sunitinib (SUN): the randomized phase 3 CheckMate -9ER trial.
- Kidney Cancer Factsheet. GLOBOCAN 2018. Accessed: February
2021. Available:
https://gco.iarc.fr/today/data/factsheets/cancers/29-Kidney-fact-sheet.pdf.
- Kidney Cancer. Mayo Clinic. Accessed: February 2021. Available:
https://www.mayoclinic.org/diseases-conditions/kidney-cancer/symptoms-causes/syc-20352664.
- Infographic: Kidney Cancer. Mayo Clinic. Accessed: February
2021. Available:
https://www.mayoclinic.org/diseases-conditions/kidney-cancer/multimedia/kidney-cancer-infographic/ifg-20441505.
- Survival rates for kidney cancer. American Cancer Society.
Accessed: February 2021. Available:
https://www.cancer.org/cancer/kidney-cancer/detection-diagnosis-staging/survival-rates.html.
- Orlin, I et al. Renal cell carcinomas epidemiology in the era
of widespread imaging. Journal of Clinical Oncology. 2019; 37:15.
DOI:
https://ascopubs.org/doi/10.1200/JCO.2019.37.15_suppl.e13083.
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version on businesswire.com: https://www.businesswire.com/news/home/20210226005280/en/
Media Giovanni Asta Head of Global Franchises
Communication/Global Head of Institutional Affairs, Patient
Advocacy & Communication/Italy +39 335 744 07 34
giovanni.asta@ipsen.com
Media and Financial Community Ipsen Global Communications
global@communication.ipsen.info
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