Ipsen showcases commitment to patient-centric advances in oncology with record number of abstracts to be presented at ESMO 2020 Virtual Congress

• 17 abstracts1 to be shared, spanning a wide range of different cancer types, therapies and clinical study and real-world evidence designs
• Presentations will feature promising data across multiple cancers, including renal cell carcinoma, small cell lung cancer, pancreatic ductal adenocarcinoma, prostate cancer and various neuroendocrine tumors
• Highlights include detailed results from the pivotal Phase III CheckMate -9ER trial, which demonstrated that Cabometyx® (cabozantinib) in combination with Opdivo® (nivolumab) significantly improved progression-free survival and overall survival with favorable safety profile in patients with previously untreated advanced renal cell carcinoma versus sunitinib

PARIS, FRANCE, 14 September 2020 – Ipsen (Euronext: IPN; ADR: IPSEY) today announced that novel clinical trial and real-world evidence data across a variety of tumor types and oncology therapeutic settings, will be the subject of multiple oral and poster presentations at the European Society for Medical Oncology (ESMO) 2020 Congress, taking place virtually 19–21 September 2020. Results from these 17 abstracts reflect Ipsen’s commitment to oncology research and mission to provide treatment options tailored to patients with significant unmet needs. The impact of this progress is highlighted by the selection of three abstracts for proffered paper presentations, with one featuring in the ESMO Presidential Symposium.
“The breadth of oncology research we’re presenting at ESMO this year highlights our commitment to prioritize the development of innovative treatment options that enhance patient care,” said Prof. Dr. Steven Hildemann, Executive Vice President, Chief Medical Officer, Head of Global Medical Affairs and Patient Safety, Ipsen. “The positive results from the pivotal Phase III CheckMate -9ER trial are just one example of our successful partnership strategy to catalyze and broaden our progress in delivering potential new or improved options in cancers with significant unmet needs.”
Highlights from key data on Ipsen medicines to be presented during the ESMO 2020 Congress include:

• Superior survival and response rates in previously untreated patients with advanced clear cell renal cell carcinoma (aRCC) with Cabometyx® (cabozantinib) in combination with Opdivo® (nivolumab) versus sunitinib.
• Real-world evidence on Cabometyx® (cabozantinib) from the CABOREAL study in non-clear cell metastatic renal cell carcinoma and sarcomatoid renal cell carcinoma, and from an interim analysis of the European CASSIOPE study in aRCC after VEGF-targeted therapy.1
• Results from the Phase II CLARINET FORTE trial detailing the efficacy and safety of increasing the frequency of Somatuline® Autogel (lanreotide) dosing in progressive pancreatic and midgut neuroendocrine tumors (NETs).1

Aligned with the virtual format of the ESMO 2020 Congress, Ipsen is launching a new virtual congress platform, which will include a virtual press office to support media in accessing further information and insights around Ipsen’s data and contribution to the ESMO 2020 scientific program, the company’s mission to advance oncology research, and its commitment to address patients’ unmet needs.
The virtual congress platform is available here and the virtual press office is available here. To receive a recording of the virtual media briefing and receive exclusive media content, please register your interest here: https://ipsenglobal.ipsenmultichannel.com/ipsen-esmo-virtual-media-briefing-19-sept/
Follow Ipsen on Twitter via @IpsenGroup and keep up to date with ESMO 2020 Congress news and updates by using the hashtag #ESMO20.
Overview of presentations featuring Ipsen medicines in development at the ESMO 2020 Congress:

About renal cell carcinoma
There are over 400,000 new cases of kidney cancer diagnosed worldwide each year.2 Of these, renal cell carcinoma (RCC) is the most common type of kidney cancer, accounting for approximately 90% of cases.3,4 It is twice as common in men, and male patients account for over two thirds of deaths.2 If detected in the early stages, the five-year survival rate is high, but for patients with advanced or late-stage metastatic RCC the survival rate is much lower, around 12%, with no identified cure for this disease.5,6

About NETs
Neuroendocrine tumors, or NETs, are a group of uncommon tumors that develop in the cells of the neuroendocrine system, throughout the body.7,8 NETs occur in both men and women, in general aged 50 to 60 years old, although they can affect anyone of any age.9
The three main areas where NETs are found in the body are the gastrointestinal tract, the pancreas and the lungs.8,10

• Gastrointestinal NETs (GI-NETs) are found in the gastrointestinal tract or digestive system and are the most common type of NETs.10
• Pancreatic NETs (panNETs) are formed in the islet cells of the pancreas and include several uncommon types of NETs.10
• Lung NETs are less common than other types, accounting for about one quarter of NETs.10

The symptoms of NETs are often not distinct and difficult to identify, and can sometimes take between five to seven years to fully diagnose.11 The number of people being newly diagnosed with NETs overall is believed to be rising.12 This is mainly due to increased awareness of the condition and diagnostic testing.12 NETs are now the fastest growing class of cancers worldwide, accounting for around 2% of all cancers at any time.12

About pancreatic cancer
Pancreatic cancer occurs when cells in the pancreas grow uncontrollably from a malignant tumor. It is the seventh leading cause of cancer death globally and the 12th most common cancer,13,14 and has the lowest survival rate of the most common cancers.15,16 As there are often no symptoms, or symptoms may be non-specific in the early stages,17 it is most commonly diagnosed at an incurable stage.18 Around 80% of pancreatic cancer patients are diagnosed with metastatic disease and for these the average survival is less than a year.19

About the CheckMate -9ER trial
CheckMate -9ER is an open-label, randomized, multi-national Phase III trial evaluating the treatment of patients with previously untreated advanced or metastatic RCC. Patients were randomized 1:1 to Opdivo® and Cabometyx® or sunitinib. The primary endpoint is progression-free survival (PFS). Secondary endpoints include overall survival (OS) and objective response rate (ORR). The primary efficacy analysis compared the doublet combination versus sunitinib in 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 CLARINET FORTE
CLARINET FORTE is a prospective single-arm, open-label, exploratory, international Phase II study to explore the efficacy and safety of a reduced lanreotide autogel dosing interval (120 mg every 14 days) in patients with metastatic or locally advanced unresectable pancreatic neuroendocrine tumors (G1/2 panNETs) 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 more than 24 weeks.

About Ipsen Products
This press release mentions investigational uses of Ipsen products. Product indications and approvals for use vary by jurisdiction; please see SmPC/PI for full indications and safety information, including Boxed Warnings.

About Cabometyx® (cabozantinib)
Cabometyx® is currently approved in 54 countries, including  in the European Union, the U.S., the U.K., Norway, Iceland, Australia, Switzerland, South Korea, Canada, Brazil, Taiwan, Hong-Kong, Singapore, Macau, Jordan, Lebanon, Russian Federation, Ukraine, Turkey, United Arab Emirates, Saudi Arabia, Serbia, Israel, Mexico, Chile and Panama for the treatment of advanced RCC in adults who have received prior VEGF-targeted therapy; in the European Union, the U.K., Norway, Iceland, Canada, Australia, Brazil, Taiwan, Hong Kong, Singapore, Jordan, Russian Federation, Turkey, United Arab Emirates, Saudi Arabia, Israel, Mexico, Chile and Panama for previously untreated intermediate- or poor-risk advanced RCC; and in the European Union, the U.S., the U.K., Norway, Iceland, Canada, Australia, Switzerland, Saudi Arabia, Serbia, Israel, Taiwan, Hong Kong, South Korea, Singapore, Jordan, Russian Federation, Turkey, United Arab Emirates, and Panama for 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 (SmPC) and in the U.S. Prescribing Information (PI).
Cabometyx® is marketed by Exelixis, Inc. in the United States and by Takeda Pharmaceutical Company Limited in Japan. Ipsen has exclusive rights for the commercialization and further clinical development of Cabometyx® outside of the U.S. and Japan.

About Somatuline® (lanreotide)
Somatuline® Autogel/Depot is made of the active substance lanreotide, which is a long-acting somatostatin analogue that inhibits the secretion of growth hormone and certain hormones secreted by the digestive system. The main indications of Somatuline® and Somatuline® Autogel are:20

• 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 detailed recommendations for the use of Somatuline® Autogel are described in the Summary of Product Characteristics (SmPC) and in the U.S. Prescribing Information (PI).

About Decapeptyl®
Decapeptyl® (triptorelin pamoate) is an agonist analogue of the natural gonadotropin-releasing hormone (GnRH), currently available in three sustained-release formulations (1, 3 and 6 months). First registered in France in 1986, triptorelin is currently marketed by Ipsen under a license agreement from Debiopharm Group in more than 80 countries, being the market leader in many territories worldwide.
The detailed recommendations for the use of Decapeptyl® are described in the Summary of Product Characteristics (SmPC).

About Onivyde® (irinotecan liposome injection)
Onivyde® is an encapsulated formulation of irinotecan available as a 43 mg/10 mL single dose vial. This liposomal form is designed to increase length of tumor exposure to both irinotecan and its active metabolite, SN- 38. Onivyde® is approved by the U.S. FDA in combination with fluorouracil (5-FU) and leucovorin (LV) for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy.
In 2017 Ipsen completed the acquisition from Merrimack Pharmaceuticals of Onivyde® and gained exclusive commercialization rights for the current and potential future indications for Onivyde® in the U.S.21 Servier is responsible for the development and commercialization of Onivyde® outside of the U.S. and Taiwan under an exclusive licensing agreement with Ipsen Biopharm Ltd.
Onivyde® is approved by the U.S. FDA in combination with fluorouracil (5-FU) and leucovorin (LV) for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy.
Servier is an international pharmaceutical company governed by a non-profit foundation, with its headquarters in France (Suresnes). More information: www.servier.com/en/.
The detailed recommendations for the use of Onivyde® are described in the Summary of Product Characteristics (SmPC) and in the U.S. Prescribing Information (PI).

About Ipsen
Ipsen is a global specialty-driven biopharmaceutical group focused on innovation and Specialty Care. The Group develops and commercializes innovative medicines in three key therapeutic areas – Oncology, Neuroscience and Rare Diseases. Its commitment to oncology is exemplified through its growing portfolio of key therapies for prostate cancer, neuroendocrine tumors, renal cell carcinoma and pancreatic cancer. Ipsen also has a well-established Consumer Healthcare business. With total sales over €2.5 billion in 2019, 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). The Group has about 5,800 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.
Opdivo® is a registered trademark of Bristol-Myers Squibb Company.

For further information:

References

1. ESMO Virtual Congress 2020: Abstracts. ESMO. Accessed: September 2020. Available: https://www.esmo.org/meetings/esmo-virtual-congress-2020/meeting-resources/abstracts.
2. Kidney Cancer Factsheet. GLOBOCAN 2018. Accessed: August 2020. Available: https://gco.iarc.fr/today/data/factsheets/cancers/29-Kidney-fact-sheet.pdf.
3. Kidney Cancer. Mayo Clinic. Accessed: August 2020. Available: https://www.mayoclinic.org/diseases-conditions/kidney-cancer/symptoms-causes/syc-20352664.
4. Infographic: Kidney Cancer. Mayo Clinic. Accessed: August 2020. Available: https://www.mayoclinic.org/diseases-conditions/kidney-cancer/multimedia/kidney-cancer-infographic/ifg-20441505.
5. Survival rates for kidney cancer. American Cancer Society. Accessed: August 2020. Available: https://www.cancer.org/cancer/kidney-cancer/detection-diagnosis-staging/survival-rates.html.
6. Orlin, I et al. Renal cell carcinomas epidemiology in the era of widespread imaging. Journal of Clinical Oncology. 2019; 37:15. DOI: https://doi.org/10.1200/JCO.2019.37.15_suppl.e1308.
7. Neuroendocrine Tumour (NETs). Macmillan. Accessed: August 2020. Available: https://www.macmillan.org.uk/cancer-information-and-support/neuroendocrine-tumours-nets.
8. Zekri et al. (2019). 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.
9. How common are NETs? LivingWithNETS. Accessed: August 2020. Available: https://www.livingwithnets.com/about-neuroendocrine-tumours-nets/learn-about-nets/how-common-are-neuroendocrine-tumours-nets/.
10. Types of NETs. LivingWithNETs. Accessed: August 2020. Available: https://www.livingwithnets.com/about-neuroendocrine-tumours-nets/learn-about-nets/types-of-neuroendocrine-tumours-nets/.
11. Symptoms of NETs. LivingWithNETs. Accessed: August 2020. Available: https://www.livingwithnets.com/about-neuroendocrine-tumours-nets/learn-about-nets/symptoms-of-neuroendocrine-tumours-nets/.
12. How common are NETs? LivingWithNETs. Accessed: August 2020. Available: https://www.livingwithnets.com/en-us/how-common-are-neuroendocrine-tumors-nets/.
13. Pancreatic Cancer: Statistics. Cancer.net. Accessed: August 2020. Available: https://www.cancer.net/cancer-types/pancreatic-cancer/statistics.
14. Pancreatic cancer statistics. World Cancer Research Fund International. Accessed: August 2020. Available: www.wcrf.org/dietandcancer/cancer-trends/pancreatic-cancer-statistics.
15. Pancreatic cancer statistics. Pancreaticcancer.org.uk. Accessed: August 2020. Available: www.pancreaticcancer.org.uk/statistics/.
16. About Pancreatic Cancer. Worldpancreaticcancerday.org. Accessed: August 2020. Available: www.worldpancreaticcancerday.org/about-pancreatic-cancer/.
17. Signs and symptoms of pancreatic cancer. Pancreaticcancer.org.uk. Accessed: August 2020. Available: www.pancreaticcancer.org.uk/information-and-support/facts-about-pancreatic-cancer/signs-and-symptoms-of-pancreatic-cancer/.
18. DaVee, T et al. Pancreatic cancer screening in high-risk individuals with germline genetic mutations. Gastrointestinal Endoscopy. 2018; 87:6, DOI: https://doi.org/10.1016/j.gie.2017.12.019
19. Azar, I et al. Treatment and survival rates of stage IV pancreatic cancer at VA hospitals: a nation-wide study. Journal of Gastrointestinal Oncology. 2019; 10:4, DOI: https://doi.org/10.21037/jgo.2018.07.08
20. Somatuline Autogel (lanreotide acetate) SmPC. December 2019. Available: https://www.medicines.org.uk/emc/product/4808/smpc
21. Ipsen Completes Acquisition of ONIVYDE® (irinotecan liposome injection) and Additional Oncology Assets from Merrimack Pharmaceuticals. Ipsen. Accessed: August 2020. Available: https://www.ipsen.com/press-releases/ipsen-completes-acquisition-of-onivyde-irinotecan-liposome-injection-and-additional-oncology-assets-from-merrimack-pharmaceuticals/

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