- Ipsen’s submission for extension of indication
for Cabometyx® (cabozantinib) based on data from the COSMIC-311
trial received validation from the European Medicines Agency in
August 2021
- Separate follow-up data presented at the
European Society for Medical Oncology Congress 2021 includes cohort
6 of the Phase Ib COSMIC-021 trial and the Phase III CheckMate -9ER
trial, reinforcing the broad utility potential of Cabometyx across
indications2-4
Disclaimer: Intended for international media
and investor audiences only
Regulatory News:
Ipsen (Euronext: IPN; ADR: IPSEY) today announced presentation
of new analyses at the European Society for Medical Oncology (ESMO)
Congress 2021 across different forms of cancer for people treated
with Cabometyx® (cabozantinib). Of note, the final analysis of the
pivotal Phase III COSMIC-311 trial (Abstract LBA67) will be
presented, with Cabometyx demonstrating a clinically meaningful,
sustained efficacy benefit versus placebo in people living with
previously treated radioactive iodine-refractory differentiated
thyroid cancer (RAI-R DTC).
With a median follow-up of 10.1 months, Cabometyx continued to
demonstrate superior median progression-free survival (mPFS) with a
reduction in the risk of disease progression or death of 78% versus
placebo (hazard ratio [HR]: 0.22, 96% confidence interval [CI]:
0.15-0.32; p<0.0001).1 This final analysis is consistent with
data from the interim analysis, presented at the American Society
of Clinical Oncology (ASCO) Annual Meeting 2021 and published in
The Lancet Oncology, (HR: 0.22; 96% CI: 0.13-0.36; p<0.0001).5,6
Further data from the final analysis also confirmed that superior
efficacy with Cabometyx was maintained irrespective of previous
vascular endothelial growth factor receptor (VEGFR)-targeted
therapy.
Efficacy and safety data from the COSMIC-311 interim analysis
formed the basis of a type II variation submission to the European
Medicines Agency (EMA) for an extension of indication for Cabometyx
in RAI-R DTC. On 14 August 2021, the EMA validated the type II
variation, confirming the submission is complete and beginning its
centralized review process.
The safety profile identified in the COSMIC-311 trial was
consistent with that previously observed for cabozantinib and
adverse events (AEs) were managed with dose modifications. The
discontinuation rate due to treatment-emergent AEs (TEAEs) was 8.8%
for Cabometyx vs. 0% for placebo. Grade 3/4 TEAEs occurred in 62%
of patients who received Cabometyx vs. 28% for placebo, with no
treatment-related grade 5 events.
Steven Hildemann, M.D., Executive Vice President, Chief Medical
Officer, Head of Global Medical Affairs and Global Patient Safety,
Ipsen said, “The therapeutic potential of Cabometyx as a key
treatment option in our arsenal against a broad range of tumors is
continuing to be realized. These final data from the COSMIC-311
trial are a strong example of how Cabometyx can make a tangible
difference to the lives of people living with cancer and we look
forward to receiving a decision from the EMA next year. We are
committed to further evaluating the role Cabometyx may continue to
play against difficult-to-treat cancers as we also look towards the
results of the ongoing Phase III trials in non-small cell lung
cancer (CONTACT-01) and metastatic castration-resistant prostate
cancer (CONTACT-02).”
Additional data to be presented at ESMO featuring Cabometyx
include new results from cohort 6 of the COSMIC-021 Phase Ib trial
evaluating the combination of Cabometyx and atezolizumab in people
living with previously treated metastatic castration-resistant
prostate cancer (mCRPC) (Abstract LBA24).2 These additional
analyses build on the interim data presented at ASCO 2020,7 with an
expanded cohort 6 of 132 patients evaluated.2 With a median
follow-up of 15.2 months, the primary endpoint of objective
response rate (ORR) assessed by investigator per RECIST 1.1
(response evaluation criteria in solid tumours) was 23%, with three
patients demonstrating a complete response (CR).2
Prof. Dr. Gunhild von Amsberg, University Medical Center
Hamburg-Eppendorf (UKE) and investigator in the CONTACT-02 trial,
said, “As a uro-oncologist, I am encouraged by the results
presented at this year’s ESMO congress. For people living with
advanced metastatic castration-resistant prostate cancer, the
prognosis is often poor and the potential of new innovative
therapies is critically important. Based on these clinically
meaningful results of Cabometyx plus atezolizumab from cohort 6 of
the COSMIC-021 trial, we now look forward to the results of the
ongoing Phase III CONTACT-02.”
Further analyses from the landmark Phase III CheckMate -9ER
trial investigating the combination of Cabometyx and nivolumab were
are also being presented at ESMO, providing additional evidence to
inform clinical decision-making in advanced renal cell carcinoma
(RCC). New data demonstrated improved efficacy for Cabometyx and
nivolumab regardless of prior nephrectomy status, when measured by
PFS, ORR, CR and response durability outcomes, versus sunitinib
(Abstract 663P).3 Additionally, a matching-adjusted indirect
comparison analysis is being presented, demonstrating superior,
statistically significant differences in health-related quality of
life across all outcomes analysed in favour of Cabometyx and
nivolumab versus the combination of axitinib and pembrolizumab
(Abstract 668P).4
More information on these data can be found during the
presentation sessions outlined below:
Title
Date and time
Cabozantinib in combination with
atezolizumab in patients with metastatic castration-resistant
prostate cancer (mCRPC): results of expanded cohort 6 of the
COSMIC-021 Study
Saturday 18 September 13:30-13:40 CEST
Cabozantinib Versus Placebo in Patients
With Radioiodine-Refractory Differentiated Thyroid Cancer (DTC) Who
Have Progressed After Prior VEGFR-Targeted Therapy: Updated Results
From the Phase 3 COSMIC-311 Trial
Monday 20 September 17:30-17:35 CEST
First-line nivolumab + cabozantinib
(NIVO+CABO) vs sunitinib (SUN) in patients (pts) with advanced
renal cell carcinoma (aRCC) in subgroups based on prior nephrectomy
in the CheckMate 9ER trial
Poster presentation – Available on-demand
beginning September 16 at 8:30 am CEST
Matching-adjusted indirect comparison
(MAIC) of health-related quality of life (HRQoL) of nivolumab plus
cabozantinib (N+C) vs pembrolizumab plus axitinib (P+A) in
previously untreated advanced renal cell carcinoma (aRCC)
Poster presentation – Available on-demand
beginning September 16 at 8:30 am CEST
About radioactive iodine-refractory differentiated thyroid
cancer (RAI-R DTC) In 2020, over 580,000 new cases of thyroid
cancer were diagnosed worldwide.8 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 one in
every 20 cancers diagnosed among women.7 While cancerous thyroid
tumors include differentiated, medullary and anaplastic forms,
differentiated thyroid tumors make up about 90 to 95% of cases.9,10
These include papillary, follicular and Hürthle cell cancer.7,8 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.11
Patients who develop RAI-R DTC have a poor prognosis with an
average estimated survival of three to five years.12
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.6 Patients were
randomized in a 2:1 ratio to receive either Cabometyx 60 mg or
placebo once-daily.6 The primary endpoints were progression-free
survival and objective response rate, evaluated by a blinded
independent radiology committee. Additional endpoints include
safety, overall survival and quality of life.2 More information
about this trial is available at ClinicalTrials.gov.
About metastatic castration-resistant prostate cancer
(mCRPC) In 2020, over 1.4 million new cases of prostate cancer
were diagnosed worldwide,13 making it the fourth most commonly
occurring cancer globally.13 Prostate cancer that has spread beyond
the prostate and does not respond to androgen-suppression therapies
which reduce the levels of testosterone, a common treatment for
prostate cancer, is known as mCRPC.14 Men diagnosed with mCRPC
often have a poor prognosis, with an estimated survival of 1-2
years.15
About the COSMIC-021 trial COSMIC-021 is a multicenter,
Phase Ib, open-label trial that is divided into two parts: a
dose-escalation phase and an expansion cohort phase. The
dose-escalation phase was designed to enroll patients either with
advanced renal cell carcinoma (RCC) with or without prior systemic
therapy or with inoperable, locally advanced, metastatic or
recurrent urothelial carcinoma (UC), (including renal, pelvis,
ureter, urinary bladder and urethra) after prior platinum-based
therapy. Ultimately, all 12 patients who enrolled in this stage of
the trial were patients with advanced RCC. The dose-escalation
phase of the study determined the optimal dose of cabozantinib to
be 40 mg daily when given in combination with atezolizumab (1200 mg
infusion once every 3 weeks).
In the expansion phase, the trial is enrolling 24 cohorts in 12
tumor types: RCC, urothelial carcinoma, non-small cell lung cancer,
CRPC, hepatocellular carcinoma, triple-negative breast cancer,
epithelial ovarian cancer, endometrial cancer, gastric or
gastroesophageal junction adenocarcinoma, colorectal
adenocarcinoma, head and neck cancer, and DTC.
Four of the cohorts are exploratory single agent cohorts. In UC,
NSCLC, CRPC with cabozantinib as a single-agent, and in CRPC with
single-agent atezolizumab.
Exelixis is the study sponsor of COSMIC-021. Both Ipsen Pharma
SAS (Ipsen) and Takeda Pharmaceutical Company Limited (Takeda) have
opted in to participate in the trial and are contributing to the
funding for this study under the terms of the companies’ respective
collaboration agreements with Exelixis. Roche is providing
atezolizumab for the trial.
About renal cell carcinoma (RCC) There are over 400,000
new cases of kidney cancer diagnosed worldwide each year.16 Of
these, RCC is the most common type of kidney cancer, accounting for
approximately 90% of cases.17,18 It is twice as common in men, and
male patients account for over two thirds of deaths.16 If detected
in the early stages, the five-year survival rate is high, but for
patients living with advanced or late-stage metastatic RCC the
survival rate is much lower, around 12%, with no identified cure
for this disease.19,20
About the CheckMate -9ER trial CheckMate -9ER was 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
Opdivo (n = 323) versus sunitinib (n = 328). The primary endpoint
is progression-free survival (PFS). Secondary endpoints include
overall survival and objective response rate. The primary efficacy
analysis compared the doublet combination versus sunitinib in all
randomized patients. The trial was sponsored by Bristol Myers
Squibb and Ono Pharmaceutical Co and co-funded by Exelixis, Ipsen
and Takeda Pharmaceutical Company Limited.
About Cabometyx (cabozantinib) In the U.S., Cabometyx
tablets are approved for the treatment of patients living with
advanced RCC; for the treatment of patients living with
hepatocellular carcinoma (HCC) who have been previously treated
with sorafenib; and for patients living with advanced RCC as a
first-line treatment in combination with nivolumab. Outside the
U.S., Cabometyx is currently approved in 59 countries, including in
the European Union, Great Britain, Norway, Iceland, Australia, New
Zealand, Switzerland, South Korea, Canada, Brazil, Taiwan, Hong
Kong, Singapore, Macau, Jordan, Lebanon, the Russian Federation,
Ukraine, Turkey, United Arabic Emirates, Saudi Arabia, Serbia,
Israel, Mexico, Chile, Peru, Panama, Guatemala, Dominican Republic,
Ecuador, Thailand, Malaysia and Egypt for the treatment of advanced
RCC in adults who have received prior VEGF-targeted therapy; in the
European Union, Great Britain, Norway, Iceland, Canada, Australia,
New Zealand, Brazil, Taiwan, Hong Kong, Singapore, Lebanon, Jordan,
the Russian Federation, Ukraine, Turkey, the United Arab Emirates
(U.A.E.)., Saudi Arabia, Israel, 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 European Union, 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 and Malaysia for 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 European Union, Great
Britain, Norway, Iceland, Switzerland, Taiwan, the Russian
Federation.
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 €2.5bn in FY 2020, Ipsen sells more than 20 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
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
product 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 and also
taking into consideration assessment delays of certain clinical
trials in light of the ongoing COVID-19 pandemic. Ipsen must face
or might face competition from generic products 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
product 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 product
concerned. There can be no guarantees a product will receive the
necessary regulatory approvals or that the product 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,
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factors, including interest rate and currency exchange rate
fluctuations; the impact of pharmaceutical industry regulation and
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containment; technological advances, new products and patents
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development, including obtaining regulatory approval; Ipsen’s
ability to accurately predict future market conditions;
manufacturing difficulties or delays; financial instability of
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innovative products; and the exposure to litigation, including
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third parties to develop and market some of its products which
could potentially generate substantial royalties; these partners
could behave in such ways which could cause damage to Ipsen’s
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obtain any benefit from those agreements. A default by any of
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situations could have a negative impact on Ipsen’s business,
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obligation or undertaking to update or revise any forward-looking
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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
the Ipsen’s 2020 Universal Registration Document, available on
ipsen.com.
References
- 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
- Agarwal et al., ESMO 2021. Cabozantinib (C) in combination with
atezolizumab (A) in patients (pts) with metastatic
castration-resistant prostate cancer (mCRPC): primary analysis of
cohort 6 of the COSMIC-021 study
- Porta et al., ESMO 2021. First-line nivolumab + cabozantinib
(NIVO+CABO) vs sunitinib (SUN) in patients (pts) with advanced
renal cell carcinoma (aRCC) in subgroups based on prior nephrectomy
in the CheckMate 9ER trial
- Porta et al., ESMO 2021. Matching-adjusted indirect comparison
(MAIC) of health-related quality of life (HRQoL) of nivolumab plus
cabozantinib (N+C) vs pembrolizumab plus axitinib (P+A) in
previously untreated advanced renal cell carcinoma (aRCC)
- Brose et al., ASCO 2021. Cabozantinib versus placebo in
patients with radioiodine-refractory differentiated thyroid cancer
who have progressed after prior VEGFR-targeted therapy: results
from the phase 3 COSMIC-311 trial.
- 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
- 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.
- 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.
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September 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.
- Prostate Cancer Fact Sheet. GLOBOCAN 2020. Last accessed:
September 2021. Available at:
https://gco.iarc.fr/today/data/factsheets/cancers/27-Prostate-fact-sheet.pdf
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accessed: September 2021. Available at:
https://www.cancer.net/cancer-types/prostate-cancer/types-treatment
- 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.
- Kidney Cancer Factsheet. GLOBOCAN 2020. Last accessed:
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