BASKING RIDGE, N.J. June 2, 2016 – Ipsen Biopharmaceuticals, Inc., an affiliate of Ipsen (Euronext: IPN; ADR: IPSEY), today announced that new data analyses of Somatuline® Depot (lanreotide) Injection 120 mg (referred to as Somatuline®) will be presented at the annual meeting of the American Society of Clinical Oncology (ASCO) being held in Chicago, Illinois, June 3 – 7, 2016.
The data include poster presentations of two new subgroup analyses of the Phase III CLARINET® study in patients with gastroenteropancreatic neuroendocrine tumors (NETs), including the last documented tumor response from CLARINET®. Also to be presented are data from two active trials of Somatuline® in non-resectable duodeno-pancreatic NETs and lung NETs.
“The data accepted for presentation at this year’s ASCO meeting demonstrates Ipsen’s continued commitment to research about Somatuline® and provides additional insights to clinicians into the activity of Somatuline® in specific tumor types,” said Cynthia Schwalm, President and CEO, Ipsen Biopharmaceuticals, Inc.
- Exploratory analysis of tumor growth rate (TGR) with lanreotide depot/autogel (LAN) in patients with neuroendocrine tumors (NETs) from the CLARINET study
- Presenter: Dr. Martin Chaplin, Royal Free Hospital, London, UK
- Abstract #4096: Poster presentation: June 4, 8:00 a.m. to 11:30 a.m., Hall A
- Clinicopathological and demographic factors associated with development of distant metastasis among patients with locoregional neuroendocrine tumor (NET)
- Presenter: Dr. James Yao, MD Anderson Cancer Center, Houston, TX
- Abstract #4099: Poster presentation June 4, 8:00 a.m. to 11:30 a.m., Hall A
- Functional status of neuroendocrine tumors in older adults: A large population-based study using SEER-Medicare Data o Presenter: Dr. James Yao, MD Anderson Cancer Center, Houston, TX
- Abstract #4097: Poster presentation June 4, 8:00 a.m. to 11:30 a.m., Hall A
- Treatment patterns and clinical outcomes of patients with metastatic gastroenteropancreatic neuroendocrine tumors (mGEP-NETs).
- Presenter: Dr. Xiao long Jiao, US Oncology/McKesson Specialty Health, The
- Abstract #e15659: E-Pub abstract
- Presenter: Dr. Xiao long Jiao, US Oncology/McKesson Specialty Health, The
- REMINET: A European multicenter, phase II/III randomized, double blind, placebo-controlled study in patients with non-resectable duodeno-pancreatic NETs (ACTIVE TRIAL)
- Presenter: Dr. Come Lepage, University of Burgundy, Dijon, France
- Abstract # TPS4148: Poster presentation June 4, 8:00 a.m. to 11:30 a.m., Hall A
- SPINET: A randomized, double-blind, placebo-controlled phase III study in patients with Lung NETs (ACTIVE TRIAL)
- Presenter: Dr. Diane Reidy-Lagunes, Memorial Sloane Cancer Center, NYC
- Abstract #TPS8580: Poster presentation June 4, 8:00 a.m. to 11:30 a.m., Hall A Indication Somatuline® Depot (lanreotide) Injection 120 mg is indicated for the treatment of adult patients with unresectable, well- or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival. Important Safety Information Contraindications: Somatuline is contraindicated in patients with hypersensitivity to lanreotide. Allergic reactions (including angioedema and anaphylaxis) have been reported following administration of lanreotide.
Warnings and Precautions:
- Cholelithiasis and Gallbladder Sludge: Somatuline may reduce gallbladder motility and lead to gallstone formation. Periodic monitoring may be needed.
- Hypoglycemia or Hyperglycemia: Pharmacological studies show that Somatuline, like somatostatin and other somatostatin analogs, inhibits the secretion of insulin and glucagon. Blood glucose levels should be monitored when Somatuline treatment is initiated, or when the dose is altered, and antidiabetic treatment should be adjusted accordingly.
- Cardiac Abnormalities: Somatuline may decrease heart rate. In 81 patients with baseline heart rates of ≥ 60 beats per minute (bpm) treated with Somatuline DEPOT in the GEP-NETs clinical trial, the incidence of heart rate < 60 bpm was 23% (19/81) with Somatuline vs 16% (15/94) with placebo; 10 patients (12%) had documented heart rates < 60 bpm on more than one visit. The incidence of documented episodes of heart rate <50 bpm or bradycardia reported as an adverse event was 1% in each treatment group. Initiate appropriate medical management in patients who develop symptomatic bradycardia. In patients without underlying cardiac disease, Somatuline may lead to a decrease in heart rate without necessarily reaching the threshold of bradycardia. In patients suffering from cardiac disorders prior to treatment, sinus bradycardia may occur. Care should be taken when initiating treatment in patients with bradycardia.
- Drug Interactions: The pharmacological gastrointestinal effects of Somatuline may reduce the intestinal absorption of concomitant drugs. Concomitant administration of Somatuline Depot may decrease the relative bioavailability of cyclosporine and may necessitate the adjustment of cyclosporine dose to maintain therapeutic levels.
In the GEP-NET pivotal trial, the most common adverse reactions (incidence >10% and more common than placebo) in patients treated with Somatuline DEPOT vs placebo were abdominal pain (34% vs 24%), musculoskeletal pain (19% vs 13%), vomiting (19% vs 9%), headache (16% vs 11%), injection site reaction (15% vs 7%), hyperglycemia (14% vs 5%), hypertension (14% vs 5%), and cholelithiasis (14% vs 7%).
You may report suspected adverse reactions to FDA at 1-800-FDA-1088 or to Ipsen Biopharmaceuticals, Inc. at 1-888-980-2889.
Please see the full Prescribing Information for Somatuline®Depot by accessing the following link.
Ipsen is a global specialty-driven biotechnological group with total sales exceeding €1.4 billion in 2015. Ipsen sells more than 20 drugs in more than 115 countries, with a direct commercial presence in more than 30 countries. Ipsen’s ambition is to become a leader in specialty healthcare solutions for targeted debilitating diseases. Its fields of expertise cover oncology, neurosciences and endocrinology. Ipsen’s commitment to oncology is exemplified through its growing portfolio of key therapies improving the care of patients. Ipsen also has a significant presence in primary care. Moreover, the Group has an active policy of partnerships. Ipsen’s R&D is focused on its innovative and differentiated technological platforms, peptides and toxins, located in the heart of the leading biotechnological and life sciences hubs (Les Ulis/Paris-Saclay, France; Slough/Oxford, UK; Cambridge, US). In 2015, R&D expenditure totaled close to €193 million. The Group has more than 4,600 employees worldwide. Ipsen’s shares are traded on segment A of Euronext Paris (stock code: IPN, ISIN code: FR0010259150) and eligible to the “Service de Règlement Différé” (“SRD”). The Group is part of the SBF 120 index. Ipsen has implemented a Sponsored Level I American Depositary Receipt (ADR) program, which trade on the over-the-counter market in the United States under the symbol IPSEY. For more information on Ipsen, visit www.ipsen.com.
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Somatuline DEPOT is a registered trademark of IPSEN PHARMA S.A.S.
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