* Detailed top-line results from Phase III CONTACT-02 trial demonstrated
statistically significant progression-free survival benefit for combination
of Cabometyx(®) and atezolizumab in metastatic castration-resistant prostate
cancer
* Four-year extended follow-up data from landmark Phase III CheckMate -9ER
trial reinforce sustained long-term efficacy benefits for the combination of
Cabometyx(®) and nivolumab versus sunitinib in advanced renal cell carcinoma
PARIS, FRANCE, 22 January 2024 - Ipsen (Euronext: IPN; ADR: IPSEY) announced
today new data to be presented for Cabometyx(®) (cabozantinib) in combination
with immunotherapy across indications at the upcoming American Society of
Clinical Oncology Genitourinary Symposium (ASCO GU) taking place on 25-27
January 2024 in San Francisco, U.S.
Detailed top-line results from the Phase III CONTACT-02 trial of the combination
of Cabometyx and atezolizumab versus a second novel hormone therapy (NHT) in
people living with metastatic castration-resistant prostate cancer (mCRPC) and
measurable extra-pelvic soft tissue disease who have progressed on one prior
NHT, are to be presented as an oral presentation (Abstract #18).
With a median follow-up of 14.3 months, data from the primary analysis of
progression-free survival (PFS) from the CONTACT-02 trial demonstrated a
statistically significant PFS benefit for the combination of Cabometyx and
atezolizumab of 6.3 months versus 4.2 months for a second NHT (hazard ratio
(HR): 0.65, 95% confidence interval (CI): 0.50-0.84; p=0.0007). At an interim
analysis for the other primary endpoint of overall survival (OS), the data
demonstrated a trend toward improvement for the combination, however, these data
were immature, and the trial will continue to the next planned analysis,
anticipated in 2024. Safety for the combination appeared to be consistent with
the known safety profiles of the individual medicines, and no new safety signals
were identified.
Prostate cancer is the second most common cancer in men(1) and for those living
with advanced metastatic castration-resistant disease, the prognosis is poor,
with an estimated survival of 1-2 years(2).
"At the advanced metastatic castration-resistant stage of disease, the prognosis
is poor, with a median survival of two years and limited available treatment
options," said Stéphane Oudard, Professor of Oncology and Chief of the Oncology
Clinical and Translational Research Unit at Georges Pompidou Hospital in Paris,
France. "These results from the CONTACT-02 trial represent a positive step in
the context of the current treatment landscape, contributing the first positive
Phase III data of its kind for the benefit of patients, as we await further data
from the overall survival analysis."
Also, four-year extended follow-up data from the landmark Phase III CheckMate
-9ER trial investigating the combination of Cabometyx and nivolumab versus
sunitinib in people living with previously untreated advanced renal cell
carcinoma (aRCC) will be presented (Abstract #362).
With a median follow-up of 55.6 months for OS, the combination of Cabometyx and
nivolumab demonstrated a sustained and clinically meaningful OS benefit versus
sunitinib, with an absolute median OS gain of 10.5 months (46.5 months for the
combination vs 36.0 months for sunitinib, HR 0.77, 95% CI: 0.63-0.95).
Additionally, median PFS remained almost double that for the combination versus
sunitinib, at 16.4 vs 8.4 months respectively (HR 0.58, 95% CI: 0.49-0.70). The
safety profile was consistent with the known safety profiles of the individual
medicines, and no new safety signals were identified.
Renal cell carcinoma is the most common form of kidney cancer(3)(, )(4) and for
the 30% of people diagnosed with an advanced form of the disease, the 5-year
survival rate is low at 12%, with no identified cure for this disease.(5)(,)(6)
"Data from our ongoing trials continue to reinforce the value of Cabometyx for
patients across a number of challenging tumor types," said Christelle Huguet,
EVP and Head of Research and Development, Ipsen. "In combination with
immunotherapy, Cabometyx is delivering long-term survival benefits today for
people living with renal cell carcinoma worldwide, while also showcasing future
potential in metastatic castration-resistant prostate cancer, an area of
significant unmet need where no other trials of this modality have proven
successful in recent decades."
Additionally, health-related quality of life (HRQoL) data from a modelling
analysis based on the CheckMate 9ER trial explored the link between HRQoL and
clinical outcomes at a median follow-up of 32.9 months (Abstract #384). These
data provide further patient-focused context to the benefits of the combination
of Cabometyx and nivolumab, whilst also reinforcing the association of the
combination with an increased chance of tumor shrinkage, survival and
progression-free survival, independent of early HRQoL deterioration.
ENDS
About Cabometyx
Cabozantinib is a small molecule that inhibits multiple receptor tyrosine
kinases (RTKs), including VEGFRs, MET, RET and the TAM family (TYRO3, MER,
AXL).(7) 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.(7)(,)(8)(,)(9)(,)(10)
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 60 countries outside of the United States and Japan, including in the
European Union (E.U.), Cabometyx is currently indicated as:(8)
* 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.
* in 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 (DTC), refractory or not
eligible to radioactive iodine (RAI) 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)
(https://www.ema.europa.eu/en/medicines/human/EPAR/cabometyx).
About mCRPC
Prostate cancer is the second most common cancer in men and the fourth most
common cancer overall globally.(1) In 2020, there were more than 1.4 million new
cases of prostate cancer and about 375,300 deaths worldwide.(1) 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.(11)
Men diagnosed with mCRPC often have a poor prognosis, with an estimated survival
of 1-2 years.(2)
About aRCC
There were over 400,000 new cases of kidney cancer diagnosed worldwide in
2020.(12) Of these, RCC is the most common type of kidney cancer, accounting for
approximately 90% of cases.(3,4) It is almost twice as common in men, and male
patients account for over two thirds of deaths.(12) At diagnosis, up to 30% of
patients present with advanced or metastatic RCC. If detected in the early
stages, the five-year survival rate is high, but for people living with advanced
or late-stage metastatic RCC, the survival rate is much lower, around 12%, with
no identified cure for this disease.(5,6)
About the CONTACT-02 trial
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 visceral disease or measurable extra-pelvic
adenopathy and who have progressed on one prior NHT. The two primary endpoints
of the trial are 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
(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fclinicaltrial
s.gov%2Fct2%2Fshow%2FNCT04446117%3Fterm%3DCONTACT%2B02%26draw%3D2%26rank%3D1&esh
eet=52243262&newsitemid=20200630005244&lan=en-
US&anchor=ClinicalTrials.gov&index=5&md5=a57eb14750da6cdf587e71d5ba55c1ee).
About the CheckMate -9ER trial
CheckMate -9ER is an open-label, randomized, multi-national Phase III trial
evaluating people living 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 nivolumab (n= 323) versus
sunitinib (n= 328). The primary endpoint is progression-free survival (PFS). The
secondary endpoints include OS and ORR. The primary efficacy analysis compared
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. More information
about CheckMate -9ER is available at ClinicalTrials.gov
(https://clinicaltrials.gov/study/NCT03141177).
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 100 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
Email: corporate.communications@ipsen.com
(mailto:corporate.communications@ipsen.com)
Investors
Craig Marks | +44 7584 349 193
Media
Joanna Parish | +44 7840 023 741
Disclaimers and/or Forward-Looking Statements
The 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
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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
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INJYRhuLZP1b2RRGQKaNMQhqDBefwdyOcUcRf2VYKHI9RWUEWA==).
References
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(2) Moreira, D. M., et al. Predicting Time From Metastasis to Overall Survival
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(3) Kidney Cancer. Mayo Clinic. Available: https://www.mayoclinic.org/diseases-
conditions/kidney-cancer/symptoms-causes/syc-20352664. Accessed: January 2024.
(4) Infographic: Kidney Cancer. Mayo Clinic. Available:
https://www.mayoclinic.org/diseases-conditions/kidney-cancer/multimedia/kidney-
cancer-infographic/ifg-20441505. Accessed: January 2024.
(5) Survival rates for kidney cancer. American Cancer Society. Available:
https://www.cancer.org/cancer/kidney-cancer/detection-diagnosis-
staging/survival-rates.html Accessed: January 2024.
(6) 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.
(7) 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.
(8) 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: January
2024
(9) Yakes M. et al., Cabozantinib (XL184), a novel MET and VEGFR2 inhibitor,
simultaneously suppresses metastasis, angiogenesis, and tumor growth. Mol Cancer
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(10) Hsu et al., AXL and MET in Hepatocellular Carcinoma: A Systematic
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(11) Prostate Cancer: Types of Treatment. Cancer.Net. Available at:
https://www.cancer.net/cancer-types/prostate-cancer/types-treatment. Accessed
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(12) Kidney Cancer Factsheet. GLOBOCAN 2020. Available:
https://gco.iarc.fr/today/data/factsheets/cancers/29-Kidney-fact-sheet.pdf.
Accessed: January 2024.
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