- A total of 9 abstracts presented at the 18th Annual European
Neuroendocrine Tumor Society (ENETS) Conference showcasing new data
across the patient pathway in neuroendocrine tumors
- Latest data from the Phase II CLARINET FORTE study are the
subject of an oral presentation showing quality of life is
maintained when doubling the dose regimen of lanreotide autogel
with no new safety signals
- These new analyses suggested no deterioration in quality of
life from baseline in patients living with pancreatic
neuroendocrine tumors (panNETs) and midgut neuroendocrine tumors
(NETs) who received lanreotide autogel (120 mg every 14 days)
following progression on the standard dose regimen
- Moreover, new data on independent injection of lanreotide
autogel highlighted the substantial impact on cost and hospital
visit reductions in the UK
Ipsen (Euronext: IPN; ADR: IPSEY) announced today a total of 9
abstracts presenting new data with a focus in NETs.1-10 These
include data from the Phase II CLARINET FORTE study and data on the
use of independent administration of lanreotide autogel to be
presented at the ENETS Conference, taking place virtually 25-27
February 2021.1-3
Updated data from the CLARINET FORTE study were presented
including additional quality of life (QoL) data showcasing
assessments of patients’ perceived QoL during the treatment period
of the study.1 QoL was assessed using three validated
questionnaires covering the severity of problems associated with
mobility, self-care, usual activities, pain/discomfort, and
anxiety/depression (EQ-5D-5L), as well as questionnaires specific
to patients with cancer (EORTC QLQ-C30) and NETs (QLQ‑GINET.21).1
Results from these measurements suggest no deterioration of QoL
with no substantial deviation from baseline prior to treatment.1
Additional pharmacokinetic (PK) analyses of the increased dosing
regimen showed that PK increased in a proportional manner and no
increase in rates of glycoregulation, cholelithiasis or
hypertension in patients with increased lanreotide autogel exposure
was observed.2 With confirmation of the PK data together with the
substantial period of QoL preservation, data from the CLARINET
FORTE study could represent a potentially meaningful treatment
option for a population of patients with high unmet needs.1-2
“The new findings from the CLARINET FORTE trial highlighted that
QoL remained stable throughout the study in patients who were
enrolled with progressive disease and who were receiving twice the
frequency of injections compared with their pre-study regimen”,
said Professor Marianne Pavel, Friedrich-Alexander University of
Erlangen, Germany, Senior Physician and Chair of Endocrinology, and
principal investigator of the study. “This is an important new
measure as it reflects the patients’ perceptions of their own
current overall health and means that patients with progressive
NETs may be able to remain on a more tolerable first-line standard
of care for longer with no new safety signals or quality of life
deterioration.”
Among the Ipsen data presented at ENETS 2021 is the presentation
of findings from a study into the potential cost savings associated
with increased uptake of independent administration of long-acting
somatostatin analogues (SSAs) for the treatment of
gastroenteropancreatic NETs (GEP-NETs) within the UK’s National
Healthcare Service (NHS).3 In the UK, lanreotide autogel is
approved for independent injection at home by the patient or a
partner*.11 Health-economic modeling suggests that when a patient
with GEP-NETs treated with octreotide long-acting release (LAR)
transition to lanreotide autogel administered via independent
injection, an average of 14.5 nurse contacts, including four
hospital visits, could potentially be avoided every year as well as
potential overall expenses per patient being lowered by 16.4%
equating to £2,458 saved per year. At a population level, the
increase in patients independently injecting SSAs, from 12.6%
(pre-COVID) to 24.5% (during COVID), may have reduced the annual
overall healthcare expenditure for the NHS from £53.4M to
£52.9M.3
“The effective remote management of patients has never been more
critical. As a chronic condition, patients living with NETs require
long-term solutions which provide continuity of treatment and
flexibility. Home administration of lanreotide autogel provides
patients living with NETs the independence to manage their own
treatment and can ease the pressure on frontline healthcare
professionals, reducing hospital visits and potentially the risk of
COVID-19 for patients,” said Lilian Cortez, author and GI
specialist pharmacist at the The Royal Marsden NHS Foundation
Trust, UK. “The potential benefits identified in this study should
be considered alongside patient experience in evaluating
pandemic-enforced practices that may be beneficial to adopt
long-term.”
Ipsen also unveiled details from multiple studies highlighting a
data-driven vision of patient-centricity, which show how mining the
wealth of data generated from a drug’s discovery to real-world use
after regulatory approval can unlock insights into the epidemiology
and clinical features of NETs. These include a retrospective study
leveraging data from five years of electronic health records to
increase understanding of NETs and help to identify new therapeutic
strategies; and results from the Phase III RAISE study
investigating the use of deep learning models and dissociated
response to predict early treatment efficacy in patients with
NETs.4,5
“True patient-centricity requires an analytical, insights-driven
mindset and at Ipsen we are pushing the boundaries to bring new
data to best serve patients and their families, and generate
pharmacoeconomic measures of Health Systems,” said Prof. Dr. Steven
Hildemann, Executive Vice President, Chief Medical Officer, Head of
Global Medical Affairs and Patient Safety, Ipsen. “Ipsen remains a
committed partner and leader in the NET landscape and our presence
at ENETS showcases how we are taking strides in making tangible
differences for patients living with NETs. As a company, we
continue to champion the empowerment of patients across the
treatment pathway.”
END
Notes to editors
About NETs
Neuroendocrine tumors, or NETs, are a group of uncommon tumors
that develop in the cells of the neuroendocrine system, throughout
the body.12,13 NETs occur in both men and women, in general aged 50
to 60 years old, although they can affect anyone of any age.14
The three licensed areas where NETs are found in the body are
the gastrointestinal tract, the pancreas and the lungs.15
- Gastrointestinal NETs (GI-NETs) are found in the
gastrointestinal tract or digestive system and are the most common
type of NETs.15
- Pancreatic NETs (panNETs) are formed in the islet cells of the
pancreas and include several uncommon types of NETs.15
- Lung NETs are less common than other types, accounting for
about one quarter of NETs.15
The symptoms of NETs are often not distinct and difficult to
identify, and can sometimes take between five to seven years to
fully diagnose.16 The number of people being newly diagnosed with
NETs overall is believed to be rising.17 This is mainly due to
increased awareness of the condition and diagnostic testing.17 NETs
are now the fastest growing class of cancers worldwide, accounting
for around 2% of all cancers at any time.17
About CLARINET FORTE
CLARINET FORTE was a prospective single-arm, open-label,
exploratory, international Phase II study to explore the efficacy
and safety of an increased lanreotide autogel dosing frequency (120
mg every 14 days) in patients with metastatic or locally advanced
unresectable pancreatic NETs or midgut NETs, with
centrally-accessed progression within the last two years while on a
standard lanreotide autogel regimen (120 mg every 28 days) for 24
weeks or more.18 Initial efficacy and safety data from the CLARINET
FORTE study were presented at the 2020 European Society for Medical
Oncology (ESMO) Congress, which took place on 19-21 September
2020.
About Somatuline® Autogel® (lanreotide)
Somatuline® Autogel®/Depot is made of the active substance
lanreotide and is a long-acting somatostatin analogue that inhibits
the secretion of growth hormone and certain hormones secreted by
the digestive system. The licensed indications of Somatuline®
Autogel® are:11
- The treatment of individuals with acromegaly when the
circulating levels of Growth Hormone (GH) and/or Insulin-like
Growth Factor-1 (IGF-1) remain abnormal after surgery and/or
radiotherapy, or in patients who otherwise require medical
treatment.
- The treatment of grade 1 and a subset of grade 2 (Ki-67 index
up to 10%) gastroenteropancreatic neuroendocrine tumors (GEP-NETs)
of midgut, pancreatic or unknown origin where hindgut sites of
origin have been excluded, in adult patients with unresectable
locally advanced or metastatic disease.
- The treatment of symptoms associated with neuroendocrine
(particularly carcinoid) tumors. The recommended starting dose is
one injection of Somatuline Autogel® 120 mg administered every 28
days.
The detailed recommendations for the use of Somatuline® Autogel®
are described in the Summary of Product Characteristics (SmPC) in
the UK.11
* The decision regarding administration by the patient or a
trained person should be taken by a healthcare professional.
About Ipsen
Ipsen is a global mid-size biopharmaceutical company with a
focus on transformative medicines in Oncology, Rare Disease and
Neuroscience. Ipsen also has a well-established Consumer Healthcare
business. With total sales over €2.5 billion in 2020, Ipsen sells
more than 20 drugs in over 115 countries, with a direct commercial
presence in more than 30 countries. Ipsen’s R&D is focused on
its innovative and differentiated technological platforms located
in the heart of the leading biotechnological and life sciences hubs
(Paris-Saclay, France; Oxford, UK; Cambridge, US; Shanghai, China).
The Group has about 5,700 employees worldwide. Ipsen is listed in
Paris (Euronext: IPN) and in the United States through a Sponsored
Level I American Depositary Receipt program (ADR: IPSEY). For more
information on Ipsen, visit www.ipsen.com.fr
Ipsen’s Forward Looking Statement
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herein are based on the Group’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 the Group’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
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events, including regulatory filings and determinations, and the
outcome of this study or other studies. 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 the
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in the future, and not exclusively on historical data. Actual
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Research and Development process involves several stages each of
which involves the substantial risk that the Group 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, the Group 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
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References
- Pavel et al., ENETS 2021. Efficacy, Safety and Quality of Life
(QoL) with Lanreotide Autogel (LAN) 120 mg Every 14 Days in
Progressive Pancreatic or Midgut Neuroendocrine Tumours (NETs):
CLARINET FORTE Study Results.
- Dehez et al., ENETS 2021. CLARINET FORTE: Characterization of
Pharmacokinetics (PK), Efficacy and Safety in Patients with
Progressive Neuroendocrine Tumors (NETs) Treated with Lanreotide
Autogel (LAN) 120 mg Every 14 Days (q14d).
- Harrow et al., ENETS 2021. Independent administration of
long-acting somatostatin analogues (SSAs) for the treatment of
gastroenteropancreatic neuroendocrine tumours (GEP-NET): potential
savings of increased uptake in the UK National Health Service
(NHS).
- Marazuela et al., ENETS 2021. Clinical Epidemiology of Patients
With Neuroendocrine Tumors (NETs) In Spain, Using Electronic Health
Records (EHRs) And Big Data Techniques.
- Pavel et al., ENETS 2021. The use of deep learning models to
predict progression-free survival in patients with neuroendocrine
tumours: results from phase 3 of the RAISE project.
- Thiis-Evensen et al., ENETS 2021. Plasma protein biomarkers for
the detection of pancreatic neuroendocrine tumors (Pan-NET) and
differentiation from small intestinal (SI) NET.
- Hautefeuille et al., ENETS 2021. OPERA: Observational Study of
Perception of Information and Quality of Life (QoL) in Patients
with Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)
Starting Lanreotide Autogel (LAN).
- Dromain et al., ENETS 2021. Dissociated response as a new
biomarker of treatment response in neuroendocrine tumours: results
from phase 3 of the RAISE project.
- Perrier et al., ENETS 2021. Cost of Carcinoid Syndrome (CS) In
France: Analysis of the National Health Insurance Database.
- Abstracts & Posters – Annual ENETS Conference. ENETS. Last
accessed: January 2021. Available from:
https://enetsconference.org/abstracts-and-posters.html.
- EMC. Somatuline Autogel (lanreotide acetate) SmPC. December
2019. Available from:
https://www.medicines.org.uk/emc/product/4808/smpc
- Neuroendocrine Tumour (NETs). Macmillan. Last accessed: January
2021. Available from:
https://www.macmillan.org.uk/cancer-information-and-support/neuroendocrine-tumours-nets.
- Zekri et al. Neuroendocrine tumor of the kidney: Diagnostic
challenge and successful therapy. Urology Annals. 2019;11:4, DOI:
https://doi.org/10.4103/UA.UA_169_18.
- How common are NETs? LivingWithNETS. Last accessed: January
2021. Available from:
https://www.livingwithnets.com/about-neuroendocrine-tumours-nets/learn-about-nets/how-common-are-neuroendocrine-tumours-nets/.
- Types of NETs. LivingWithNETs. Last accessed: January 2021.
Available from:
https://www.livingwithnets.com/about-neuroendocrine-tumours-nets/learn-about-nets/types-of-neuroendocrine-tumours-nets/.
- Symptoms of NETs. LivingWithNETs. Last accessed: January 2021.
Available from:
https://www.livingwithnets.com/about-neuroendocrine-tumours-nets/learn-about-nets/symptoms-of-neuroendocrine-tumours-nets/.
- How common are NETs? LivingWithNETs. Last accessed: January
2021. Available from:
https://www.livingwithnets.com/en-us/how-common-are-neuroendocrine-tumors-nets/.
- Pavel M et al. 1162MO Efficacy and safety of lanreotide autogel
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https://doi.org/10.1016/j.annonc.2020.08.1375.
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