In adult patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic GEP-NETs.1,3
The Median PFS for Somatuline Depot was not yet reached at 22 months (95% CI NE, NE) compared with 16.6 months for placebo (95% CI: 11.2-22.1).1
Number of events (N=204): Somatuline Depot 32 (31.7%) vs placebo 60 (58.3%).1
CI=Confidence interval. NE=Not reached at 22 months.1
Adverse reactions reported in CLARINET study
Most common adverse reactions (greater than 10%) are abdominal pain, musculoskeletal pain, vomiting, headache, injection site reaction, hyperglycemia, hypertension, and cholelithiasis.1
Please see CLARINET study design and Patient Information below.
Study design and patient information
CLARINET*: A phase III, 96-week, randomized, double-blind, placebo-controlled, pivotal trial1
The majority (84%) of patients in CLARINET had not received prior pharmacologic therapy for GEP-NETs. Some patients (16%) received prior therapy.3
Patients were excluded if they received3:
— An SSA at any time, unless they received it >6 months prior to study entry and for <15 days
— Interferon, chemoembolization, or chemotherapy: <6 months prior to study entry
*CLARINET=Controlled Study of Lanreotide Antiproliferative Response In NeuroEndocrine Tumors.3
†Administered every 28 days by deep subcutaneous injection. Follow-up visits occurred at Weeks 12, 24, 36, 48, 72, 96.3
‡Assessed by a central independent radiological review in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0.3
Progression-free survival in the ITT population3
CLARINET included patients with unresectable, well- to moderately-differentiated, locally advanced or metastatic GEP-NETs, a range of hepatic tumor loads, and varying primary tumor locations (foregut/pancreas, midgut, or hindgut).
IMPORTANT SAFETY INFORMATION & INDICATIONS
- SOMATULINE DEPOT 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 DEPOT may reduce gallbladder motility and lead to gallstone formation.
- Periodic monitoring may be needed.
- If complications of cholelithiasis are suspected, discontinue SOMATULINE DEPOT and treat appropriately.
- Hypoglycemia or Hyperglycemia
- Patients treated with SOMATULINE DEPOT may experience hypoglycemia or hyperglycemia.
- Blood glucose levels should be monitored when SOMATULINE DEPOT treatment is initiated, or when the dose is altered, and antidiabetic treatment should be adjusted accordingly.
- Cardiovascular Abnormalities
- SOMATULINE DEPOT may decrease heart rate.
- In patients without underlying cardiac disease, SOMATULINE DEPOT 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.
Most Common Adverse Reactions
- GEP-NETs: Adverse reactions in >10% of patients who received SOMATULINE DEPOT were abdominal pain (34%), musculoskeletal pain (19%), vomiting (19%), headache (16%), injection site reaction (15%), hyperglycemia (14%), hypertension (14%), and cholelithiasis (14%).
- Carcinoid Syndrome: Adverse reactions occurring in the carcinoid syndrome trial were generally similar to those in the GEP-NET trial. Adverse reactions in ≥5% of patients who received SOMATULINE DEPOT and at least 5% greater than placebo were headache (12%), dizziness (7%) and muscle spasm (5%).
- SOMATULINE DEPOT may decrease the absorption of cyclosporine (dosage adjustment may be needed); increase the absorption of bromocriptine; and require dosage adjustment for bradycardia-inducing drugs (e.g., beta-blockers).
- Lactation: Advise women not to breastfeed during treatment and for 6 months after the last dose.
To report SUSPECTED ADVERSE REACTIONS, contact Ipsen Biopharmaceuticals, Inc. at 1-855-463-5127 or FDA at 1-800-FDA-1088 or www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program.
- 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; and
- the treatment of adults with carcinoid syndrome; when used, it reduces the frequency of short-acting somatostatin analog rescue therapy.
- Somatuline Depot (lanreotide) Injection [Prescribing Information]. Cambridge, MA: Ipsen Biopharmaceuticals, Inc.; June 2019.
- Data on file. Basking Ridge, NJ: Ipsen Biopharmaceuticals, Inc.; 2018. This study has been funded by Ipsen.
- Caplin ME, Pavel M, Ćwikła JB, et al, for the CLARINET Investigators. Lanreotide in metastatic enteropancreatic neuroendocrine tumors. N Engl J Med. 2014;371(3):224-233.
- Vinik AI, Wolin EM, Liyanage N, Gomez-Panzani E, Fisher GA; on behalf of the ELECT Study Group. Evaluation of lanreotide depot/autogel efficacy and safety as a carcinoid syndrome treatment (ELECT): a randomized, double-blind, placebo-controlled trial. Endocr Pract.2016;22(9):1068-1080.
- Ipsen data on file. IQVIA patient claims, 2015 Q1–2019 Q3.
- Adelman D, Truong Thanh X-M, Feuilly M, Houchard A, Cella D. Evaluation of nurse preferences between the lanreotide autogel new syringe and the octreotide long-acting release syringe: an international simulated-use study (PRESTO). Adv Ther. 2020. https://doi.org/10.1007/s12325-020-01255-8.
- Data on file. Basking Ridge, NJ: Ipsen Biopharmaceuticals, Inc.; 2007.
- Ryan P, McBride A, Ray D, et al. Lanreotide vs octreotide LAR for patients with advanced gastroenteropancreatic neuroendocrine tumors: An observational time and motion analysis. J Oncol Pharm Pract. 2019;25(6):1425-1433.
- Adelman DT, Truong Thanh X-M, Mégret C. Enhancing patient care: co-creation and validation of a new and improved delivery system for lanreotide autogel/depot and its evaluation by US healthcare professionals. Presented at the 101st Annual Meeting and Expo of the Endocrine Society. New Orleans, LA; March 23-26, 2019.
- Giving a Subcutaneous Injection. Bethesda, MD: National Institutes of Health Clinical Center; July 2016.
- Wolin EM, Manon A, Chassaing C, et al. Lanreotide depot: an antineoplastic treatment of carcinoid or neuroendocrine tumors. J Gastrointest Cancer. 2016;47(4):366-374.