- Approval based on data from the COSMIC-311
Phase III trial, in which Cabometyx® (cabozantinib) demonstrated a
78% reduction in risk of disease progression or death versus
placebo1
- This milestone marks the first treatment
option to be specifically approved as a second-line therapy in this
indication
Disclaimer: Intended for international media
and investor audiences only
Regulatory News:
Ipsen (Euronext: IPN; ADR: IPSEY) today announced that the
European Commission (EC) has approved the use of Cabometyx®
(cabozantinib) as a monotherapy for the treatment of adult patients
with locally advanced or metastatic differentiated thyroid
carcinoma (DTC), refractory or not eligible to radioactive iodine
who have progressed during or after prior systemic therapy. This
approval is the first of its kind in Europe for this uncommon
condition, with limited treatment options currently available
should patients progress after prior use of systemic therapy.
Jaume Capdevila, M.D. PhD, Medical Oncologist at the Vall
d´Hebron University Hospital and Vall d'Hebron Institute of
Oncology (VHIO), Barcelona, and a trial investigator, said, “The
nature of radioiodine-refractory differentiated thyroid cancer
means that this condition does not respond to the most commonly
used standard of care for differentiated thyroid cancer. As a
result, people living with this form of the disease have had
limited treatment options should their disease progress. I am
pleased to see the entrance of a new innovative treatment in
Cabometyx, following limited progress for patients in this area for
such a significant amount of time and I look forward to sharing
more positive conversations with my patients on the number of
options available to them.”
The EC approval was based on results from the pivotal COSMIC-311
Phase III trial, which at a planned interim analysis, confirmed
that the trial had met the primary endpoint of progression free
survival (PFS), demonstrating a significant reduction in the risk
of disease progression or death by 78% versus placebo (hazard ratio
[HR]: 0.22; 96% confidence interval [CI]: 0.13-0.36; P<0.0001)
at a median follow-up of 6.2 months.1 The other primary endpoint,
the objective response rate, also favored Cabometyx with 15% vs. 0%
for placebo (p=0.028) at a median follow-up of 8.9 months, but did
not meet the criteria for statistical significance.1 Given the
efficacy and safety demonstrated within this analysis, the
independent data monitoring committee recommended to stop enrolment
and unblind sites and patients. The final results, at a median
follow-up of 10.1 months, were then presented at the European
Society for Medical Oncology (ESMO) Virtual Congress 2021, whereby
Cabometyx continued to demonstrate superior median PFS of 11.0
months versus 1.9 months with placebo and a maintained reduction in
the risk of disease progression or death of 78% versus placebo
([HR]: 0.22, 96% [CI]: 0.15-0.32; p<0.0001). These new analyses
also demonstrated that superior efficacy was maintained with
Cabometyx irrespective of previous vascular endothelial growth
factor receptor (VEGFR)-targeted therapy, supporting flexible
sequencing decisions for physicians. The safety profile identified
in the COSMIC-311 trial across the two analyses was consistent with
that previously observed for Cabometyx and adverse events were
managed with dose modifications.1,2
Steven Hildemann, M.D. PhD, Executive Vice President, Chief
Medical Officer, Head of Global Medical Affairs and Global Patient
Safety at Ipsen, said, “Confirmation of the approval of Cabometyx
for this difficult-to-treat cancer is welcome news for patients and
treating physicians. We are delighted that the European Commission
has recognized the strength of the COSMIC-311 data and the
possibilities that Cabometyx can deliver for people living with
radioactive-iodine-refractory differentiated thyroid cancer. We are
committed to researching areas of oncology with high unmet medical
needs and this decision exemplifies our ambition to bring
meaningful new treatments that have the potential to make tangible
differences to people’s lives.”
This EC approval follows the U.S. Food and Drug Administration
approval announced by Exelixis in September 2021 of Cabometyx for
the treatment of adult and pediatric patients 12 years of age and
older with locally advanced or metastatic DTC that has progressed
following prior vascular endothelial growth factor receptor
targeted therapy and who are radioactive iodine-refractory or
ineligible.
Ipsen wishes to thank the patients and investigators involved in
the COSMIC-311 clinical trial.
About radioactive iodine-refractory differentiated thyroid
cancer (RAI-R DTC) In 2020, over 580,000 new cases of thyroid
cancer were diagnosed worldwide.3 Thyroid cancer is the ninth most
commonly occurring cancer globally and incidence is three times
higher in women than in men, with the disease representing 1 in
every 20 cancers diagnosed among women.4 While cancerous thyroid
tumors include differentiated, medullary and anaplastic forms,
differentiated thyroid cancer (DTC) makes up about 90 to 95% of
cases.5,6 These include papillary, follicular and Hürthle cell
cancer.3,4 DTC is typically treated with surgery, followed by
ablation of the remaining thyroid tissue with radioactive iodine
(RAI), but approximately 5 to 15% of cases are resistant to RAI
treatment.7 Patients who develop RAI-R DTC have a poor prognosis
with an average estimated survival of three to five years.8
About the COSMIC-311 trial COSMIC-311 is a multicenter,
randomized, double-blind, placebo-controlled Phase III trial that
enrolled 258 patients at 164 sites globally.1,2 Patients were
randomized in a 2:1 ratio to receive either Cabometyx 60 mg or
placebo once-daily.1 The primary endpoints were progression-free
survival in the intention-to-treat population as well as objective
response rate in the first 100 randomly assigned patients
(objective response rate intention-to-treat [OITT] population),
both evaluated by a blinded independent radiology committee.
Additional endpoints include safety, overall survival and quality
of life.1 Exelixis is the sponsor of the COSMIC-311 trial, and
Ipsen is co-funding the trial. More information about this trial is
available at ClinicalTrials.gov.
About Cabometyx (cabozantinib) Outside the United States
and Japan, Cabometyx is currently approved in 60 countries,
including in the European Union (E.U.), Great Britain, Norway,
Iceland, Australia, New Zealand, Switzerland, South Korea, Canada,
Brazil, Taiwan, Hong Kong, Singapore, Macau, Jordan, Lebanon, the
Russian Federation, Ukraine, Turkey, the United Arabic Emirates
(U.A.E.), Saudi Arabia, Serbia, Israel, Mexico, Chile, Peru,
Panama, Guatemala, the Dominican Republic, Ecuador, Thailand,
Malaysia, Colombia and Egypt for the treatment of advanced renal
cell carcinoma (RCC) in adults who have received prior vascular
endothelial growth factor (VEGF)-targeted therapy; in the E.U.,
Great Britain, Norway, Iceland, Canada, Australia, New Zealand,
Brazil, Taiwan, Hong Kong, Singapore, Lebanon, Jordan, the Russian
Federation, Ukraine, Turkey, the U.A.E., Saudi Arabia, Israel,
Serbia, Mexico, Chile, Peru, Panama, Guatemala, the Dominican
Republic, Ecuador, Thailand, Egypt and Malaysia for previously
untreated intermediate- or poor-risk advanced RCC; and in the E.U.,
Great Britain, Norway, Iceland, Canada, Australia, Switzerland,
Saudi Arabia, Serbia, Israel, Taiwan, Hong Kong, South Korea,
Singapore, Jordan, the Russian Federation, Ukraine, Turkey,
Lebanon, the U.A.E., Peru, Panama, Guatemala, Chile, the Dominican
Republic, Ecuador, Thailand, Brazil, New Zealand, Egypt and
Malaysia for hepatocellular carcinoma (HCC) in adults who have
previously been treated with sorafenib. Cabometyx is also approved
in combination with nivolumab as first-line treatment for people
living with advanced RCC, in the E.U., Great Britain, Norway,
Iceland, Switzerland, Canada, Taiwan, Singapore, the U.A.E.,
Australia, Chile, Israel, Thailand, Malaysia, South Korea, Saudi
Arabia, the Russian Federation and Brazil. In the U.S., Cabometyx
tablets are approved for the treatment of people living with
advanced RCC; for the treatment of people living with HCC who have
been previously treated with sorafenib; for people living with
radioactive iodine-refractory differentiated thyroid cancer who
have been previously treated with VEGFR-targeted therapy; and for
people living with advanced RCC as a first-line treatment in
combination with nivolumab.
The detailed recommendations for the use of Cabometyx are
described in the Summary of Product Characteristics (EU SmPC) and
in the U.S. Prescribing Information (USPI).
Ipsen has exclusive rights for the commercialization of
Cabometyx outside the U.S. and Japan. Cabometyx is marketed by
Exelixis in the U.S. and by Takeda Pharmaceutical Company Limited
in Japan. Cabometyx is a registered trademark of Exelixis.
About Ipsen Ipsen is a global, mid-sized
biopharmaceutical company focused on transformative medicines in
Oncology, Rare Disease and Neuroscience; it also has a
well-established consumer healthcare business. With total sales of
over €2.9bn in FY 2021, Ipsen sells more than 25 medicines in over
115 countries, with a direct commercial presence in more than 30
countries. The company’s research and development efforts are
focused on its innovative and differentiated technological
platforms located in the heart of leading biotechnological and
life-science hubs: Paris-Saclay, France; Oxford, U.K.; Cambridge,
U.S.; Shanghai, China. Ipsen has c.5,700 colleagues worldwide and
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’s Forward-Looking Statements The forward-looking
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These targets depend on conditions or facts likely to happen in the
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taking into consideration assessment delays of certain clinical
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cannot be certain that favorable results obtained during
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References
- Brose et al., Cabozantinib for radioiodine-refractory
differentiated thyroid cancer (COSMIC-311): a randomised,
double-blind, placebo-controlled, phase 3 trial. Lancet Oncology.
2021; 22:8. DOI:https://doi.org/10.1016/S1470-2045(21)00332-6.
- Capdevila et al., ESMO 2021. Cabozantinib (C) versus placebo
(P) in patients (pts) with radioiodine-refractory (RAIR)
differentiated thyroid cancer (DTC) who have progressed after prior
VEGFR-targeted therapy: updated results from the phase 3 COSMIC-311
trial and prespecified subgroup analyses based on prior
VEGFR-targeted therapy.
- Sung. H et al. Global cancer statistics 2020: GLOBOCAN
estimates of incidence and mortality worldwide for 36 cancers in
185 countries. CA: A Cancer Journal For Clinicians. doi:
10.3322/caac.21660.
- Agarwal et al., ASCO 2020. Cabozantinib in combination with
atezolizumab in patients with metastatic castration-resistant
prostate cancer: Results of cohort 6 of the COSMIC-021 study.
- Cancer.Net. ASCO. Thyroid Cancer: Introduction. Last accessed:
December 2021. Available at:
https://www.cancer.net/cancer-types/thyroid-cancer/introduction.
- Chen D. et al. Innovative analysis of distant metastasis in
differentiated thyroid cancer. Oncol Lett 19: 1985-1992, 2020. doi:
10.3892/ol.2020.11304.
- Worden F. Treatment strategies for radioactive
iodine-refractory differentiated thyroid cancer. Ther Adv Med
Oncol. 6:267–279. doi: 10.1177/1758834014548188.
- Fugazzola L. et al. 2019 European Thyroid Association
Guidelines for the Treatment and Follow-Up of Advanced
Radioiodine-Refractory Thyroid Cancer. Eur Thyroid J.
2019;8:227–245. doi: 10.1159/000502229.
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