- Trial
investigating Cabometyx®
(cabozantinib) in combination with atezolizumab
demonstrated a positive trend towards improvement for one of the
primary endpoints of overall survival, but did not meet statistical
significance
- Ipsen will
not pursue regulatory submissions for the combination regimen in
countries where we have commercialization rights (outside of the US
and Japan)
- We remain
confident in the proven profile of Cabometyx as a monotherapy and
in combination with immunotherapy, across approved and potential
future indications
PARIS, FRANCE, 15 September 2024
- Ipsen (Euronext: IPN; ADR: IPSEY) announced today
detailed final overall survival (OS) data from the Phase III
CONTACT-02 trial investigating the combination of Cabometyx®
(cabozantinib) and atezolizumab in metastatic castration-resistant
prostate cancer (mCRPC). The trial investigated the combination
regimen versus a second novel hormonal therapy (NHT) in men
previously treated with one NHT and measurable soft-tissue disease.
At a median follow-up of 24.0 months, these data demonstrated a
numerical but not statistically significant improvement in OS for
the combination versus a second NHT (hazard ratio: 0.89; 95%
confidence interval: 0.72-1.10; P=0.296). As previously announced,
the trial met the other primary endpoint of progression-free
survival (PFS), demonstrating a statistically significant benefit
in PFS.1 Safety for the combination appeared to be consistent with
the known safety profiles of the individual medicines, and no new
safety signals were identified.
Based on the results of the final OS analysis
and anticipated challenging regulatory environment in the countries
in which Ipsen has commercialization rights (outside the US and
Japan), Ipsen will not pursue regulatory submissions for this
combination regimen in mCRPC.
We remain confident, in the proven profile of
Cabometyx as a monotherapy and in combination with immunotherapy
across approved indications, as well as its ongoing future
potential.
Ipsen wishes to thank the patients, their
families and healthcare teams for their participation in this
clinical trial.
ENDS
About Cabometyx
Cabometyx (cabozantinib) is a small molecule
that inhibits multiple receptor tyrosine kinases, including VEGFRs,
MET, RET and the TAM family (TYRO3, MER, AXL).2 These receptor
tyrosine kinases are involved in both normal cellular function and
pathologic processes such as oncogenesis, metastasis, tumor
angiogenesis (the growth of new blood vessels that tumors need to
grow), drug resistance, modulation of immune activities and
maintenance of the tumor microenvironment.2,3,4,5
Exelixis granted Ipsen exclusive rights for the
commercialization and further clinical development of Cabometyx
outside of the U.S. and Japan. Exelixis granted exclusive rights to
Takeda Pharmaceutical Company Limited (Takeda) for the
commercialization and further clinical development of Cabometyx for
all future indications in Japan. Exelixis holds the exclusive
rights to develop and commercialize Cabometyx in the U.S.
In over 65 countries outside of the United
States and Japan, including in the European Union, Cabometyx is
currently indicated as a:3
- Monotherapy for advanced renal cell
carcinoma (aRCC).
- as first-line treatment of adults
with intermediate- or poor-risk disease.
- in adults following prior
VEGFR-targeted therapy.
- A combination with nivolumab for
the first-line treatment of aRCC in adults.
- Monotherapy for the treatment of
adults living with locally advanced or metastatic differentiated
thyroid carcinoma, refractory or not eligible to radioactive iodine
who have progressed during or after prior systemic therapy.
- Monotherapy for the treatment of
hepatocellular carcinoma 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
(EU SmPC).
About mCRPC
Prostate cancer is the second most common cancer
in men and the fourth most common cancer overall globally.6 In
2020, there were more than 1.4 million new cases of prostate cancer
and about 375,300 deaths worldwide.6 Prostate cancer is considered
mCRPC when it has spread beyond the prostate and does not respond
to androgen-suppression therapies, a common treatment for prostate
cancer.7 Men diagnosed with mCRPC often have a poor prognosis, with
an estimated survival of 1-2 years.8
About CONTACT-02
CONTACT-02 is a global, multicenter, randomized,
Phase III, open-label study that enrolled 575 patients who were
randomized 1:1 to the experimental arm of Cabometyx in combination
with atezolizumab and the control arm of a second NHT (either
abiraterone and prednisone or enzalutamide). The study included
patients with mCRPC who have measurable extra-pelvic soft tissue
metastasis and who have progressed on one prior NHT. The two
primary endpoints of the trial are progression-free survival (PFS)
and OS. The PFS analysis was conducted in the first 400 randomized
patients (PFS in the intent-to-treat [ITT] population) and assessed
by a blinded independent radiology committee (BIRC) per RECIST 1.1.
The OS analysis was conducted in the ITT population (n=507). The
secondary endpoint is objective response rate (ORR) per BIRC. The
trial is sponsored by Exelixis and co-funded by Ipsen, Roche and
Takeda. Takeda is conducting the trial in Japan. More information
about CONTACT-02 is available at ClinicalTrials.gov.
About Ipsen
We are a global biopharmaceutical company with a
focus on bringing transformative medicines to patients in three
therapeutic areas: Oncology, Rare Disease and Neuroscience.
Our pipeline is fueled by external innovation
and supported by nearly 100 years of development experience and
global hubs in the U.S., France and the U.K. Our teams in more than
40 countries and our partnerships around the world enable us to
bring medicines to patients in more than 80 countries.
Ipsen is listed in Paris (Euronext: IPN) and in
the U.S. through a Sponsored Level I American Depositary Receipt
program (ADR: IPSEY). For more information, visit ipsen.com.
Ipsen contacts
Investors
- Craig
Marks | +44 7584 349 193
Media
- Amy
Wolf | +41 7 95 76 07 23
- Emma
Roper | +44 7711 766 517
Disclaimers and/or Forward-Looking
StatementsThe forward-looking statements, objectives and
targets contained herein are based on Ipsen’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 Ipsen’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 Ipsen’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 Ipsen. 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 medicine
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. Ipsen must face or might
face competition from generic medicine 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 Ipsen may fail to achieve its objectives and
be forced to abandon its efforts with regards to a medicine in
which it has invested significant sums. Therefore, Ipsen cannot be
certain that favorable results obtained during preclinical 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 medicine concerned. There can be
no guarantees a medicine will receive the necessary regulatory
approvals or that the medicine 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 healthcare legislation;
global trends toward healthcare cost containment; technological
advances, new medicine and patents attained by competitors;
challenges inherent in new-medicine development, including
obtaining regulatory approval; Ipsen’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 Ipsen’s patents
and other protections for innovative medicines; and the exposure to
litigation, including patent litigation, and/or regulatory actions.
Ipsen also depends on third parties to develop and market some of
its medicines which could potentially generate substantial
royalties; these partners could behave in such ways which could
cause damage to Ipsen’s activities and financial results. Ipsen
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 Ipsen’s partners could generate lower revenues
than expected. Such situations could have a negative impact on
Ipsen’s business, financial position or performance. Ipsen
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. Ipsen’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 Ipsen’s latest
Universal Registration Document, available on ipsen.com.
References
1 Agarwal et al. Cabozantinib Plus Atezolizumab
vs Second Novel Hormonal Therapy in Patients With Metastatic
Castration-Resistant Prostate Cancer (mCRPC): Primary Analyses From
the Phase 3 CONTACT-02 Study. As presented at the ASCO GU congress
2024, San Francisco, USA2 El-Khoueiry A. et al., Cabozantinib: An
evolving therapy for hepatocellular carcinoma. Cancer Treatment
Reviews. 2021 Jul;98:102221. DOI: 10.1016/j.ctrv.2021.102221.3
European Medicines Agency. Cabometyx® (cabozantinib) EU Summary of
Product Characteristics. Available from:
https://www.ema.europa.eu/en/documents/product-information/cabometyx-epar-product-information_en.pdf.
Last accessed: September 20244 Yakes M. et al., Cabozantinib
(XL184), a novel MET and VEGFR2 inhibitor, simultaneously
suppresses metastasis, angiogenesis, and tumor growth. Mol Cancer
Ther. 2011;10:2298–2308. DOI: 10.1158/1535-7163.MCT-11-02645 Hsu et
al., AXL and MET in Hepatocellular Carcinoma: A Systematic
Literature Review. Liver Cancer 2021 DOI: 10.1159/0005205016
Prostate cancer statistics. World Cancer Research Fund
International. Available at:
https://www.wcrf.org/cancer-trends/prostate-cancer-statistics/.
Accessed August 20247 Prostate Cancer: Types of Treatment.
Cancer.Net. Available at:
https://www.cancer.net/cancer-types/prostate-cancer/types-treatment.
Accessed September 20248 Moreira, D. M., et al. Predicting Time
From Metastasis to Overall Survival in Castration-Resistant
Prostate Cancer: Results From SEARCH. Clin Genitourin Cancer. 2017;
15: 60–66.e2
- Ipsen PR_CONTACT-02 ESMO_15092024
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