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  • EFFICACY
  • PFS in GEP-NETs

PROVEN FOR PFS IN PATIENTS WITH GEP-NETs1,2

Somatuline® Depot reduced the risk of tumor progression by greater than half vs placebo1,2

Somatuline Depot improved PFS for patients with GEP-NETs – studied in adult patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic GEP-NETs1,2

  • 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; FDA=Food and drug Administration;
GEP-NET=gastroenteropancreatic neuroendocrine tumor; NE=not estimable;
PFS=progression-free survival.
NE=Not reached at 22 months.1

The first FDA-approved treatment in GEP-NETs proven to reduce tumor growth1,2

  • 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; FDA=Food and drug Administration;
GEP-NET=gastroenteropancreatic neuroendocrine tumor; NE=not estimable; PFS=progression-free survival.
NE=Not reached at 22 months.1

Adverse reactions reported in the CLARINET study

Adverse reactions reported in the CLARINET study1

Most common adverse reactions (greater than 10%) were abdominal pain, musculoskeletal pain, vomiting, headache, injection site reaction, hyperglycemia, hypertension, and cholelithiasis.1

Please also see CLARINET trial study design and Patient Information below.

Please also see CLARINET trial study design and Patient Information below.

Study design and patient population information
CLARINET: The first and only Phase 3 trial of an SSA powered for PFS and a comprehensive study of the antitumor effect in patients with GEP-NETs1,2

Study design and patient population information image

The majority (84%) of patients in CLARINET had not received prior pharmacologic therapy for GEP-NETs. Some patients (16%) received prior therapy.2

 

Patients were excluded if they received:2

  • 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.2

†Administered every 28 days by deep subcutaneous injection. Follow-up visits occurred at Weeks 12, 24, 36, 48, 72, 96.2

‡Assessed by a central independent radiological review in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0.1,2

Disease characteristics

Progression-free survival studied in a comprehensive and robust patient population2

CLARINET, the first and only long-acting SSA trial to include patients with unresectable, well- to moderately differentiated, locally advanced or metastatic GEP-NETs, a range of hepatic tumor loads, and varying primary tumor locations (pancreas, midgut, or hindgut).2

Main characteristics and treatment options from patients included in the Phase 3 trials evaluating the role of SSAs in NETs1-3

Localization Midgut Pancreas High liver tumor burden (>25%)
Grade of Differentiation G1 G2 G1 G2
Ki-67 <2% 2%-10% <2% 2%-10%
First-Line SSA
Treatment		 Somatuline
Depot*
Localization Midgut Pancreas High liver tumor burden(>25%)
Grade of Differentiation G1 G2 G1 G2
Ki 67 <2% 2%-10% <2% 2%-10%
First-Line SSA Treatment
Somatuline Depot*

Adapted from Pozas J, San Román M, Alonso-Gordoa T, et al. Targeting angiogenesis in pancreatic neuroendocrine tumors: resistance mechanisms. Int J Mol Sci. 2019;20(19):4949.

*Baseline prognostic characteristics were similar between arms with one exception: There were 39% of patients in the Somatuline Depot arm and 27% of patients in the placebo arm who had hepatic involvement by tumor of >25%.1

Learn about Somatuline Depot & Carcinoid Syndrome

FDA=Food and Drug Administration; G=grade; GEP-NET=gastroenteropancreatic neuroendocrine tumor; ITT=intent-to-treat; PFS=progression-free survival; SSA=somatostatin analog.

REFERENCES:

  • Somatuline Depot (lanreotide) Injection [Prescribing Information]. Cambridge, MA: Ipsen Biopharmaceuticals, Inc.; February 2023.
  • Caplin ME, Pavel M, Ćwikła JB, et al.; on behalf of the CLARINET Investigators. Lanreotide in metastatic enteropancreatic neuroendocrine tumors. N Engl J Med. 2014;371(3):224-233.
  • Pozas J, San Román M, Alonso-Gordoa T, et al. Targeting angiogenesis in pancreatic neuroendocrine tumors: resistance mechanisms. Int J Mol Sci. 2019;20(19):4949.

IMPORTANT SAFETY INFORMATION & INDICATIONS

Contraindications

  • 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%).

Drug Interactions

  • 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).

Special Populations

  • 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.

INDICATIONS

  • SOMATULINE® DEPOT (lanreotide) is a somatostatin analog 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; and
  • the treatment of adults with carcinoid syndrome; when used, it reduces the frequency of short-acting somatostatin analog rescue therapy.

Please click here for the full Prescribing Information and Patient Information.

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