Ipsen expands collaboration and license agreement for development
of Cabometyx® in advanced neuroendocrine tumors based on positive
CABINET Phase III trial
- Decision adds to
existing collaboration agreement with Exelixis, permitting Ipsen to
seek potential marketing authorizations for
Cabometyx® (cabozantinib) in
advanced pancreatic and extra pancreatic neuroendocrine tumors
outside of the U.S. and Japan
- Agreement based on CABINET
Phase III trial, led by the Alliance for Clinical Trials in
Oncology, which demonstrated improvements in progression-free
survival for Cabometyx versus placebo
1
- Ipsen has
engaged with regulatory authorities in the European Union and will
submit a regulatory filing on the basis of these data
PARIS, FRANCE, 2 July 2024 -
Ipsen (Euronext: IPN; ADR: IPSEY) announced today confirmation of
an expanded collaboration and license agreement with Exelixis, Inc.
for the development of Cabometyx® (cabozantinib) in advanced
pancreatic neuroendocrine tumors (pNETs) and advanced
extra-pancreatic neuroendocrine tumors (epNETs). The agreement is
based on positive outcomes from the CABINET Phase III trial, led by
the Alliance for Clinical Trials in Oncology and sponsored by the
National Cancer Institute (NCI), which investigated Cabometyx
versus placebo in people living with advanced pNETs or advanced
epNETs whose disease had progressed after prior systemic therapy.
An independent Data and Safety Monitoring Board recommended to stop
accrual to the study, unblind patients and allow crossover from
placebo to Cabometyx. This was due to early efficacy demonstrated
at an interim analysis in both of the trial’s cohorts, with
clinically meaningful improvements in progression-free survival
(PFS).1
“With many people diagnosed with neuroendocrine
tumors at an advanced stage of disease and treatment options
limited upon progression, the need for efficacious new therapies is
extensive,” said Christelle Huguet, EVP and Head of Research and
Development, Ipsen. “The positive results demonstrated for
Cabometyx within the CABINET Phase III trial represent clinically
meaningful improvements in progression-free survival at a
challenging stage of disease where there are few or no available
treatment options. We look forward to discussing these clinical
findings with regulatory authorities.”
Neuroendocrine tumors (NETs) are a group of
uncommon tumors that develop in the cells of the neuroendocrine
system throughout the body.2,3 The symptoms of NETs are often not
distinct and difficult to identify, leading to delays in diagnosis,
with 58% of people presenting with metastatic disease at
diagnosis.3 The number of people newly diagnosed with NETs is
believed to be rising due to increasing awareness and better
methods of diagnosis, with approximately 35 in every 100,000 people
currently living with NETs globally.3,4 The survival rate varies
greatly depending on the primary site and stage of disease, however
for people living with advanced pNETs which has spread to distant
parts of the body, the prognosis is poor, with a five-year survival
rate of 23%.5
CABINET Phase III trial
Data from the study, which demonstrated PFS
benefits at interim analyses, were presented at the European
Society for Medical Oncology Congress 2023 by Professor Jennifer
Chan, MD, MPH, Dana-Farber Cancer Institute, Boston:1
- In the pNET cohort, at a median
follow-up of 16.7 months, median PFS based on local radiology
review was 11.4 months for Cabometyx versus 3.0 months for placebo
(hazard ratio (HR) 0.27 [95% confidence interval (CI) 0.14-0.49]
p<0.0001)1
- In the epNET cohort, at a median
follow-up of 13.9 months, median PFS based on local radiology
review was 8.3 months for Cabometyx versus 3.2 months for placebo
(HR 0.45 [95% CI 0.30-0.66] p<0.0001)1
- The safety profile of Cabometyx
observed in each cohort was consistent with its known safety
profile; no new safety signals were identified1
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).6 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.6,7,8,9
In 2016, Exelixis granted Ipsen exclusive rights
for the commercialization and further clinical development of
Cabometyx outside of the U.S. and Japan. In 2017, 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 U.S. and
Japan, including in the E.U., Cabometyx is currently indicated as
a:7
- 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, 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 neuroendocrine tumors
NETs are relatively uncommon and develop from
cells of the neuroendocrine system; thus, can arise from a variety
of locations throughout the body.2,3 The most common sites of NETs
include the gastrointestinal (GI) tract, lungs and pancreas.2,10
Most NETs take years to develop and grow slowly, however some NETs
can be fast-growing.2 The symptoms of NETs are often difficult to
identify leading to patients being seen by multiple specialists and
undergoing extensive testing before diagnosis is confirmed.3 As a
result, almost a third of people take at least 5 years to be
diagnosed with NETs.3 The five-year survival rate is dependent on
the primary site of disease. For advanced GI-NET and lung NETs,
where the cancer has spread to distant parts of the body, the
five-year survival rates are 68% and 55%, respectively.11,12 For
people diagnosed with advanced pNET, however, the prognosis is
poor, with a five-year survival rate of 23%.5
About CABINET
CABINET (randomized, double-blinded Phase III
trial of CABozantinib versus placebo In patients with advanced
NEuroendocrine Tumors after progression on prior therapy) is
sponsored by the National Cancer Institute (NCI), part of the
National Institutes of Health, and is being led and conducted by
the NCI-funded Alliance for Clinical Trials in Oncology with
participation from the NCI-funded National Clinical Trials Network,
as part of Exelixis’ collaboration through a Cooperative Research
and Development Agreement with the NCI’s Cancer Therapy Evaluation
Program.
The multicenter, Phase III CABINET pivotal trial
enrolled a total of 290 patients in the U.S at the time of the
interim analyses. Patients were randomized 2:1 to Cabometyx or
placebo in two separate cohorts (pNET, n=93; epNET, n=197). The
epNET cohort included patients with the following primary tumor
sites: gastrointestinal tract, lung, unknown and other. Each cohort
was randomized separately and had its own statistical analysis
plan. Patients must have had measurable disease per RECIST 1.1
criteria and must have experienced disease progression or
intolerance after at least one U.S. Food and Drug
Administration-approved line of prior therapy other than
somatostatin analogs. The primary endpoint in each cohort was PFS
per RECIST 1.1 by retrospective independent central review. Upon
confirmation of disease progression, patients were unblinded, and
those receiving placebo were permitted to cross over to open-label
therapy with Cabometyx. Secondary endpoints included overall
survival, radiographic response rate and safety. More information
about this trial 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 fuelled 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
- Joanna
Parish | +44 7840 023 741
- 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
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expressly disclaims any obligation or undertaking to update or
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contained in this press release to reflect any change in events,
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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 Chan et al. Alliance A021602: Ph 3,
double-blinded study of Cabozantinib vs Placebo for advanced NETs
after progression on prior therapy (CABINET). As presented at ESMO
Congress 2023 during the ‘Proffered Paper session - NETs and
endocrine tumours’ on 22 October 2023 08:40-08:50 CEST, Madrid,
Spain. 2 Neuroendocrine tumor (NET).
https://www.cancer.gov/pediatric-adult-rare-tumor/rare-tumors/rare-endocrine-tumor/carcinoid-tumor.
Accessed June 2024.3 Singh et al. Patient-Reported Burden of a
Neuroendocrine Tumor (NET) Diagnosis: Results From the First Global
Survey of Patients With NETs. J Glob Oncol. 2017 Feb; 3(1): 43–53.4
Durma et al. Epidemiology of Neuroendocrine Neoplasms and Results
of Their Treatment with [177Lu]Lu-DOTA-TATE or [177Lu]Lu-DOTA-TATE
and [90Y]Y-DOTA-TATE—A Six-Year Experience in High-Reference Polish
Neuroendocrine Neoplasm Center. Cancers 2023, 15(22), 5466;
https://doi.org/10.3390/cancers152254665 Survival Rates for
Pancreatic Neuroendocrine Tumor. American Cancer Society Available
at:
https://www.cancer.org/cancer/types/pancreatic-neuroendocrine-tumor/detection-diagnosis-staging/survival-rates.html.
Accessed June 2024. Accessed June 2024.6 El-Khoueiry A. et al.,
Cabozantinib: An evolving therapy for hepatocellular carcinoma.
Cancer Treatment Reviews. 2021 Jul;98:102221. DOI:
10.1016/j.ctrv.2021.102221.7 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: June 20248 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-11-02649 Hsu et al.,
AXL and MET in Hepatocellular Carcinoma: A Systematic Literature
Review. Liver Cancer 2021 DOI: 10.1159/00052050110 Jamal et al.
Neuroendocrine tumor of the kidney. Diagnostic challenge and
successful therapy. Urology Annals 11(4):p 435-438, Oct–Dec
2019. DOI: 10.4103/UA.UA_169_1811 Survival Rates for
Gastrointestinal Carcinoid Tumors. ACS website. Available at:
https://www.cancer.org/cancer/types/gastrointestinal-carcinoid-tumor/detection-diagnosis-staging/survival-rates.html.
Accessed June 2024.
12 Survival Rates for Lung Carcinoid Tumors. ACS
website. Available at:
https://www.cancer.org/cancer/types/lung-carcinoid-tumor/detection-diagnosis-staging/survival-rates.html.
Accessed June 2024.
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