Latest Phase III trial data investigating Cabometyx® in combination
with immunotherapy to be presented at ASCO GU 2024
- 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 men1 and for those living with advanced metastatic
castration-resistant disease, the prognosis is poor, with an
estimated survival of 1-2 years2.
“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 cancer3, 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).
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.
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.
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
Investors
Craig Marks | +44 7584 349
193
Media
Joanna Parish | +44 7840 023
741
Disclaimers and/or Forward-Looking
Statements
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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,
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determinations. Moreover, the targets described in this document
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assumptions and potential future acquisitions, which may alter
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on conditions or facts likely to happen in the future, and not
exclusively on historical data. Actual results may depart
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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
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References
1 Prostate cancer statistics. World Cancer Research
Fund International. Available at:
https://www.wcrf.org/cancer-trends/prostate-cancer-statistics/.
Last accessed January 2024.2 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.e2.3 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 20249 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-11-026410 Hsu et al.,
AXL and MET in Hepatocellular Carcinoma: A Systematic Literature
Review. Liver Cancer 2021 DOI: 10.1159/00052050111 Prostate Cancer:
Types of Treatment. Cancer.Net. Available at:
https://www.cancer.net/cancer-types/prostate-cancer/types-treatment.
Accessed January 2024.12 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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