This site is intended for U.S. healthcare providers only.

3 Reasons. 1 Somatuline® Depot. (lanreotide) Injection 120 mg

Progression-Free Survival (PFS) in Patients With GEP-NETs*

For unresectable, well- or moderately-differentiated, locally advanced or metastatic GEP-NETs

The efficacy of Somatuline Depot was tested in a phase III, 96-week, international, randomized, double-blind, placebo-controlled trial called CLARINET.1,2†

Primary Endpoint: Median PFS for Somatuline Depot vs Placebo in CLARINET
53%
reduction in risk of progression or death with Somatuline Depot vs placebo1

At the end of 22 months, the median PFS was not yet reached for Somatuline Depot compared to 16.6 months for placebo (95% CI: 11.2-22.1)1

Number of events (%)
  • Somatuline Depot=32 (31.7)
  • Placebo=60 (58.3)

The efficacy of Somatuline Depot was studied in 204 patients with unresectable, well- or moderately-differentiated, metastatic or locally advanced, gastroenteropancreatic neuroendocrine tumors. Patients were required to have nonfunctioning tumors without hormone-related symptoms.1

For additional information about the study methodology, please see Study Design and Patient Information below.

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 Adverse Reactions below for more information about these possible side effects. Please tap or click here to review the full Important Safety Information for Somatuline Depot.

*GEP-NETs=gastroenteropancreatic neuroendocrine tumors. CLARINET=Controlled Study of Lanreotide Antiproliferative Response In NeuroEndocrine Tumors.

Primary Endpoint: Median PFS for Somatuline Depot vs Placebo in CLARINET

CLARINET*: A Phase III Pivotal Trial

CLARINET Study Design CLARINET Study Design
  • The majority (84%) of patients in CLARINET had not received prior pharmacologic therapy for GEP-NETs. Some patients (16%) received prior therapy2
  • Patients were excluded if they received2:
    • Somatostatin analog 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. Administered every 28 days by deep subcutaneous injection. Follow-up visits occurred at Weeks 12, 24, 36, 48, 72, 96. Assessed by a central independent radiological review in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0.

Disease Characteristics

Somatuline® Depot has been studied in various tumor locations and visceral disease burdens Somatuline® Depot has been studied in various tumor locations and visceral disease burdens

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).1,2

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

CLARINET: Adverse Reactions

CLARINET: Adverse Reactions Occurring in less than 5% of Somatuline Depot-Treated Patients and Occurring More Commonly Than in Placebo- Treated Patients in the Phase III Trial CLARINET: Adverse Reactions Occurring in less than 5% of Somatuline Depot-Treated Patients and Occurring More Commonly Than in Placebo- Treated Patients in the Phase III Trial

aIncludes preferred terms of abdominal pain, abdominal pain upper/lower, abdominal discomfort. bIncludes preferred terms of myalgia, musculoskeletal discomfort, musculoskeletal pain, back pain. cIncludes preferred terms of infusion site extravasation, injection site discomfort, injection site granuloma, injection site hematoma, injection site hemorrhage, injection site induration, injection site mass, injection site nodule, injection site pain, injection site pruritus, injection site rash, injection site reaction, injection site swelling. dIncludes preferred terms of diabetes mellitus, glucose tolerance impaired, hyperglycemia, type 2 diabetes mellitus. eIncludes preferred terms of hypertension, hypertensive crisis. fIncludes preferred terms of depression, depressed mood. *Includes one or more serious adverse events (SAEs) defined as any event that results in death, is life-threatening, results in hospitalization or prolongation of hospitalization, results in persistent or significant disability, results in congenital anomaly/birth defect, or may jeopardize the patient and may require medical or surgical intervention to prevent one of the outcomes listed. Defined as hazardous to well-being, significant impairment of function or incapacitation.

Discontinuation rates due to treatment-emergent adverse reactions1:

  • 5% (5/101) in the Somatuline Depot arm and 3% (3/103) in the placebo arm
 

Carcinoid Syndrome1

Somatuline Depot is FDA-approved to treat adults with carcinoid syndrome; when used, it reduces the frequency of short-acting somatostatin analog rescue therapy.

The most common adverse reactions occurring in the carcinoid syndrome trial were generally similar to those in the GEP-NET trial. Adverse reactions occurring in greater than 5% of patients who received Somatuline Depot in the carcinoid syndrome trial and occurring at least 5% greater than placebo were headache (12%), dizziness (7%), and muscle spasm (5%).

ELECT* Study Design3

ELECT Study Design ELECT Study Design

OL=open-label; OLE=open-label extension. Primary endpoint: Percentage of days with use of rescue octreotide acetate (surrogate efficacy endpoint).

The patient population had a mean age of 59 years (range, 27-85 years); 58% were female and 77% were Caucasian.1

Fifty-six percent of patients had received octreotide prior to randomization, and 84% of patients experienced moderate or severe diarrhea or flushing at baseline.1

Key inclusion criteria were positive somatostatin receptor status and absence of tumor progression. Key exclusion criteria included3:
  • History of known allergy or hypersensitivity to Somatuline Depot or octreotide
  • History of CS refractory to treatment with conventional doses of SSA
  • Treatment with interferon, chemotherapy, and/or radiotherapy and/or tumor debulking <3 months prior to screening visit

*ELECT=Evaluation of Lanreotide Depot/Autogel Efficacy and Safety as a Carcinoid Syndrome Treatment.

Baseline Patient Characteristics From ELECT

Baseline Demographics and Clinical Characteristics from ELECT Baseline Demographics and Clinical Characteristics from ELECT

*Baseline symptoms assessed during screening phase. DB=double-blind; ITT=intention-to-treat; SD=standard deviation; LAN=lanreotide autogel/depot.

ELECT: Adverse Reactions

ELECT Adverse Reactions ELECT Adverse Reactions
 

Deep Subcutaneous Injection and Formulation1,3

  • Provided in a prefilled, low-volume, single-use syringe intended for administration by a healthcare provider
  • Recommended dose is 120 mg/0.5 mL administered every 4 weeks via deep subcutaneous injection to the superior external quadrant of the buttock
    • Remove from refrigerator 30 minutes prior to administration and allow to come to room temperature with pouch sealed until just prior to injection
    • Injection site should alternate between right and left sides
    • Skin should not be folded and needle should be inserted perpendicular to the skin, rapidly and to its full length
  • If already being treated for GEP-NETs, do not administer an additional dose for the treatment of carcinoid syndrome
Somatuline® Depot injection and administration
Safe'n'Sound® syringe technology
No reconstitution required1
Somatuline® Depot injection and administration

Safe’n’Sound® syringe technology

Liquid Crystal Formulation

  • A high density of nanotubes allows for a low injection volume in the ready-to-use prefilled syringe. It is believed that lanreotide forms a depot that functions as a reservoir for the drug between extended doses1,4
  • Lanreotide is slowly released, enabling once-monthly delivery via deep subcutaneous injection. Lanreotide passively diffuses toward the surrounding tissues and is absorbed into the bloodstream1
Somatuline® Depot unique liquid crystal formulation
Somatuline® Depot unique liquid crystal formulation