- Three-year data – with a median
follow-up of 44 months – from the Phase III CheckMate -9ER trial
demonstrate maintained overall survival benefits with Cabometyx
plus nivolumab compared to sunitinib regardless of IMDC risk
score1
- Data represent the longest reported
follow-up in any Phase III trial with a tyrosine kinase inhibitor-
immunotherapy regimen in this population
- CheckMate -9ER data to be presented
at ASCO GU alongside six additional abstracts supporting the use of
Cabometyx either alone or in combination with immunotherapy in
advanced renal cell carcinoma2,3,4,5,6,7
PARIS, FRANCE Ipsen (Euronext:
IPN; ADR: IPSEY) today announced three-year minimum, 44-month
median, follow-up results from the Phase III CheckMate -9ER trial
showing that Cabometyx® (cabozantinib) in combination with
nivolumab provides survival and response rate benefits after
three-years in the first-line treatment of advanced renal cell
carcinoma (aRCC), compared to sunitinib.1 These findings are being
presented at the American Society of Clinical Oncology
Genitourinary Cancers Symposium (ASCO GU) from 16–18 February
2023.
RCC is the most common type of kidney cancer,
accounting for approximately 90% of cases.8 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, at around 12%.9
“Despite the progress made through science and
medicine, there remains a need for treatment options that can
durably extend survival for patients with metastatic renal cell
carcinoma, especially for those classified as higher risk,” said
Mauricio Burotto, M.D., medical director, Bradford Hill Clinical
Research Center, Santiago, Chile. “With these updated results from
CheckMate -9ER, we’ve now seen nivolumab in combination with
cabozantinib durably extend survival and sustain response benefits
compared to sunitinib for over three years, regardless of patients’
risk classification. These results reinforce the importance of this
immunotherapy-tyrosine kinase inhibitor regimen for patients and
its potential to help change survival expectations for patients
with this challenging cancer.”
In the CheckMate -9ER trial, OS (overall
survival) benefits were maintained at over three-years of
follow-up.1 Median OS was significantly higher for patients on
Cabometyx in combination with nivolumab versus sunitinib, at 49.5
versus 35.5 months respectively [hazard ratio (HR) 0.70 [95%
confidence interval (CI) 0.56–0.87], p=0.0014)], demonstrating a
30% reduction in the risk of death.1 Additionally, median OS
improved by 11.8 months since the previous data cut at 32.9 months
median follow-up.1
Patients treated with Cabometyx in combination
with nivolumab, versus those on sunitinib, also experienced
benefits in terms of progression-free survival (PFS) and objective
response rate (ORR; cancer shrinking with treatment):1
- Median PFS was almost doubled at
16.6 versus 8.4 months for Cabometyx in combination with nivolumab
versus sunitinib respectively (HR 0.58 [95% CI 0.48–0.71],
p<0.0001).
- ORR was doubled with Cabometyx in
combination with nivolumab versus sunitinib (95% CI, 56% [50–61]
versus 28% [24–34]). Responses also continued to be more durable
with the combination, with a median DoR (duration of response) of
23.1 months compared to 15.2 months with sunitinib.
- Complete Response (CR) more than
doubled for patients receiving Cabometyx in combination with
nivolumab (12%) compared to those receiving sunitinib (5%).
- The safety profile identified in
the CheckMate -9ER trial was consistent with that previously
observed.
- Results were also assessed by the
following International Metastatic Renal Cell Carcinoma Database
Consortium (IMDC) risk scores: favorable, intermediate,
intermediate/poor and poor. Benefits were seen with Cabometyx in
combination with nivolumab across all efficacy measures (OS, PFS,
ORR and CR), regardless of IMDC risk.1
“At Ipsen, our goal is for people to live longer
and live well with cancer and these results reinforce the value
Cabometyx can bring to patients with advanced RCC when combined
with immunotherapy in the first-line setting,” said Steven
Hildemann, M.D. PhD, Executive Vice President, Chief Medical
Officer, Head of Global Medical Affairs and Global Patient Safety.
“The results from the CheckMate -9ER study continue to demonstrate
sustained, now three-year long-term benefits for people living with
advanced renal cell carcinoma across the most meaningful efficacy
measures and risk scores, adding to the body of evidence we have
for Cabometyx plus nivolumab. We sincerely thank the patients who
participated in the trial, their families and their healthcare
teams.”
Six additional abstracts will be presented at
ASCO GU assessing the benefits of Cabometyx in aRCC and non-clear
cell renal cell carcinoma (nccRCC). These include:
- The CaboCombo trial, which is a
prospective, international, non-interventional study of first-line
Cabometyx plus nivolumab for the treatment of patients with aRCC.
This study will gather real-world evidence on the first-line use of
Cabometyx plus nivolumab and demonstrates Ipsen’s commitment to
advancing the evidence base on treatment options for people living
with aRCC.3
- Cohort 10 of the COSMIC-021 trial,
which evaluates Cabometyx in combination with atezolizumab in
nccRCC, and further assesses Cabometyx’s potential when combined
with immune checkpoint inhibitors.7
- A biomarker analysis from the
CheckMate -9ER trial showing that at 44-month median follow-up,
median PFS and OS were improved with Cabometyx plus nivolumab
versus sunitinib, regardless of PD-L1 status.4
ENDS
More information can be found during the presentation sessions
outlined below:
Lead author/Presenter |
Indication |
Abstract title |
Presentation number/timing (PST) |
Laurence Albiges |
aRCC |
CaboPoint: Interim results from a Phase II study of cabozantinib
after checkpoint inhibitor (CPI) therapy in patients with advanced
renal cell carcinoma (RCC)2 |
Oral and PosterAbstract #606Sat 18 Feb8:25 – 8:20
AMRapid Abstract Session: Renal and Rare Tumors |
Philippe Barthélémy |
aRCC |
CaboCombo: a prospective international non-interventional study of
first-line cabozantinib plus nivolumab for the treatment of
patients with advanced renal cell carcinoma3 |
PosterAbstract #TPS740Sat 18 Feb7:00 – 8:00 AM;
12:30 – 2:00 PMTrials in Progress Poster Session C: Renal Cell
Cancer; Adrenal, Penile, Urethral, and Testicular Cancers |
Mauricio Burotto |
aRCC |
Nivolumab plus cabozantinib versus sunitinib for first-line
treatment of advanced renal cell carcinoma (aRCC): 3-year follow-up
from the Phase III CheckMate -9ER trialError! Bookmark not
defined. |
OralAbstract #603Sat 18 Feb2:10 – 2:20 PMOral
Abstract Session C: Renal and Rare Tumors |
Toni K. Choueiri |
aRCC |
Biomarker analysis from the Phase III CheckMate -9ER trial of
nivolumab + cabozantinib (N+C) v sunitinib (S) for advanced renal
cell carcinoma (aRCC)4 |
PosterAbstract #608Sat 18 Feb7:00 – 8:00 AMPoster
Session C: Renal Cell Cancer; Adrenal, Penile, Urethral and
Testicular Cancers |
Paul Nathan, presented by Anand Sharma |
aRCC |
CARINA interim analysis: a non-interventional study of real-world
treatment sequencing and outcomes in patients with advanced renal
cell carcinoma initiated on first-line checkpoint inhibitor-based
combination therapy5 |
PosterAbstract #626Sat 18 Feb7:00 – 8:00 AM; 12:30
– 2:00 PMPoster Session C: Renal Cell Cancer; Adrenal, Penile,
Urethral, and Testicular Cancers |
Antoine Thiery Vuillemin |
aRCC |
Study of cabozantinib in second line under real-life setting in
patients with advanced renal cell carcinoma (aRCC): study design of
a French, retrospective, multicenter study (OCTOPUS)6 |
PosterAbstract #TPS744Sat 18 Feb7:00 – 8:00 AM;
12:30 – 2:00 PMTrials in Progress Poster Session C: Renal Cell
Cancer; Adrenal, Penile, Urethral, and Testicular Cancers |
Bradley McGregor |
Non clear cell RCC |
Cabozantinib in combination with atezolizumab in non-clear cell
renal cell carcinoma: extended follow-up results of cohort 10 of
the COSMIC-021 study7 |
PosterAbstract #684Sat 18 Feb7:00 – 8:00 AM; 12:30
– 2:00 PMPoster Session C: Renal Cell Cancer; Adrenal, Penile,
Urethral and Testicular Cancers |
Notes to editors
About renal cell carcinoma
(RCC)There were over 400,000 new cases of kidney cancer
diagnosed worldwide in 2020.10 Of these, RCC is the most common
type of kidney cancer, accounting for approximately 90% of cases.8
It is almost twice as common in men, and male patients account for
over two thirds of deaths.9,10 At diagnosis, up to 30% of patients
present with advanced or metastatic RCC.11 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.9
About the CheckMate
-9ER trial12CheckMate -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
overall survival (OS) and objective response rate (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.
About the
CaboCombo trial13CaboCombo is a
prospective, international, real-world non-interventional study to
evaluate the effectiveness and tolerability of Cabometyx and
nivolumab in combination as a first-line treatment in adults with
aRCC with clear cell-component, according to real-world clinical
practice. A total of 311 patients will be enrolled across 70
centers in countries where the Cabometyx and nivolumab combination
has marketing authorization and reimbursement. The decision to
prescribe the combination will be made prior to, and independently
from, the decision to enroll patients in the trial. The primary
endpoint is real-world landmark overall survival assessed 18 months
after the combination initiation. The CaboCombo study is sponsored
by Ipsen.
About the COSMIC-021
trial14COSMIC-021 is a multicenter, Phase Ib, open-label
study that was divided into two parts: a dose-escalation phase and
an expansion cohort phase. In the expansion phase, the trial
enrolled 24 cohorts in 12 tumor types: non-small cell lung cancer
(NSCLC), RCC, urothelial carcinoma (UC), castration-resistant
prostate cancer, hepatocellular carcinoma, triple-negative breast
cancer, epithelial ovarian cancer, endometrial cancer, gastric or
gastroesophageal junction adenocarcinoma, colorectal
adenocarcinoma, head and neck cancer, and differentiated thyroid
cancer (DTC). Exelixis is the study sponsor of COSMIC-021. Both
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 Cabometyx
(cabozantinib)Cabozantinib is a small molecule that
inhibits multiple receptor tyrosine kinases (RTKs), including
VEGFRs, MET, RET and the TAM family (TYRO3, MER, AXL). 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.
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 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:
- Monotherapy for advanced renal cell
carcinoma:
- as first-line treatment of adult
patients with intermediate or poor risk
- in adults following prior vascular
endothelial growth factor (VEGF)-targeted therapy
- In combination with nivolumab for
the first-line treatment of advanced renal cell carcinoma in
adults
- Monotherapy for the treatment of
adult patients 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 (HCC) 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) and in the U.S. Prescribing Information (USPI).
About Ipsen Ipsen is a global
mid-sized biopharmaceutical company focused on transformative
medicines in Oncology, Rare Disease and Neuroscience. With
Specialty Care sales of €3.0bn in FY 2022, Ipsen sells medicines in
over 100 countries. Alongside its external-innovation strategy, 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 around 5,000 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
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 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
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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 health care legislation;
global trends toward health care cost containment; technological
advances, new products and patents attained by competitors;
challenges inherent in new product 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 products; 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 products which could potentially generate substantial
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cannot be certain that its partners will fulfil their obligations.
It might be unable to obtain any benefit from those agreements. A
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expressly disclaims any obligation or undertaking to update or
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For further information:
Contacts |
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Investors |
|
Craig MarksVice President, Investor Relations+44
7584 349 193 |
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Media |
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Joanna
ParishGlobal Head of Franchise Communications, Oncology+44
7840 023 741 |
|
References1 Burotto, M., et al. Nivolumab plus
cabozantinib vs sunitinib for first-line treatment of advanced
renal cell carcinoma (aRCC): 3-year follow-up from the phase 3
CheckMate -9ER trial. Presented at ASCO Genitourinary Cancers
Symposium; 2023 February 16-18; San Francisco, California.2
Albiges, L., et al. CaboPoint: Interim results from a phase II
study of cabozantinib after checkpoint inhibitor (CPI) therapy in
patients with advanced renal cell carcinoma (RCC). Presented at
ASCO Genitourinary Cancers Symposium; 2023 February 16-18; San
Francisco, California.3 Barthélémy, P., et al. CaboCombo: a
prospective international non-interventional study of first-line
cabozantinib plus nivolumab for the treatment of patients with
advanced renal cell carcinoma. Presented at ASCO Genitourinary
Cancers Symposium; 2023 February 16-18; San Francisco, California.4
Choueiri, T., et al. Biomarker analysis from the phase III
CheckMate -9ER trial of nivolumab + cabozantinib (N+C) v sunitinib
(S) for advanced renal cell carcinoma (aRCC). Presented at ASCO
Genitourinary Cancers Symposium; 2023 February 16-18; San
Francisco, California.5 Nathan, P., et al. CARINA interim analysis:
a non-interventional study of real-world treatment sequencing and
outcomes in patients with advanced renal cell carcinoma initiated
on first-line checkpoint inhibitor-based combination therapy.
Presented at ASCO Genitourinary Cancers Symposium; 2023 February
16-18; San Francisco, California.6 Vuillemin, A., et al. Study of
cabozantinib in second line under real-life setting in patients
with advanced renal cell carcinoma (aRCC): study design of a
French, retrospective, multicenter study (OCTOPUS). Presented at
ASCO Genitourinary Cancers Symposium; 2023 February 16-18; San
Francisco, California.7 McGregor, B., et al. Cabozantinib in
combination with atezolizumab in non-clear cell renal cell
carcinoma: extended follow-up results of cohort 10 of the
COSMIC-021 study. Presented at ASCO Genitourinary Cancers
Symposium; 2023 February 16-18; San Francisco, California.8 Hsieh,
J.J., et al. 2017. Renal cell carcinoma. Nature reviews. Disease
primers. 3(17009), doi: 10.1038/nrdp.2017.99 Padala, S.A., et al.
2020. Epidemiology of Renal Cell Carcinoma. World Journal of
Oncology. 11(3) 79-87, doi: 10.14740/wjon127910 GLOBOCAN 2020.
Kidney Cancer Factsheet. Available at:
https://gco.iarc.fr/today/data/factsheets/cancers/29-Kidney-fact-sheet.pdf
Last accessed: February 2023.11 Lalani, A.A., et al. 2022. Evolving
landscape of first-line combination therapy in advanced renal
cancer: a systematic review. Ther Adv Med Oncol. 14, 1-17, doi:
10.1177/1758835922110868512 Clinicaltrials.gov. 2022. A Study of
Nivolumab Combined With Cabozantinib Compared to Sunitinib in
Previously Untreated Advanced or Metastatic Renal Cell Carcinoma
(CheckMate -9ER). Available at:
https://clinicaltrials.gov/ct2/show/NCT03141177?term=NCT03141177&draw=2&rank=1.
Last accessed: February 2023.13 Clinicaltrials.gov. 2022. A Study
of the Effectiveness of Cabozantinib in Combination With Nivolumab
as First-line Treatment of Advanced Renal Cell Carcinoma (aRCC) in
Adults (CaboCombo). Available at:
https://clinicaltrials.gov/ct2/show/NCT05361434?term=NCT05361434&draw=2&rank=1.
Last accessed: February 2023.14 Clinicaltrials.gov. 2022. Study of
Cabozantinib in Combination With Atezolizumab to Subjects With
Locally Advanced or Metastatic Solid Tumors. Available at:
https://clinicaltrials.gov/ct2/show/NCT03170960?term=NCT03170960&draw=2&rank=1.
Last accessed: February 2023.
- ASCO-GU-press-release-02-2023
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