Somatuline Depot Approved for Gastroenteropancreatic Neuroendocrine Tumors

The Food and Drug Administration has approved Somatuline Depot (lanreotide) for the treatment of patients with unresectable, well or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs), based on findings from the phase 3 CLARINET study.

The treatment was approved under the agency’s priority review program, based on a significant extension in progression-free survival (PFS). According to results published in The New England Journal of Medicine, treatment with Somatuline Depot improved PFS by 53 percent compared with placebo for patients with grade 1 or 2 GEP-NETs. Moreover, quality of life was found to be similar between patients treated with Somatuline Depot and placebo.

In the CLARINET study, 204 patients were randomized to Somatuline Depot or placebo. Treatment was administered once a month for 24 months. Most patients had stable disease and had not yet received treatment. In total, 33 percent of patients had a hepatic tumor load greater than 25 percent.

In the study, PFS extended over 22 months in the experimental arm; however, the median was not reached at the time of the analysis. The median PFS in the placebo arm was 16.6 months. At the end of 24 months, the estimated PFS rate was 65 percent in the Somatuline Depot arm compared with 33 percent with placebo.

After the 24-month study period, patients in the placebo arm were allowed to crossover to receive Somatuline Depot. In total, 47 patients randomized to placebo received Somatuline Depot during the follow-up period. As a result of this crossover, a significant difference in overall surival was not demonstrated.

The most common adverse events with Somatuline Depot versus placebo were abdominal pain, musculoskeletal pain, vomiting, headache and injection site reaction. Severe adverse events occurred in 26 percent of patients.

The FDA initially approved Somatuline Depot in 2007 as a long-term treatment for patients with acromegaly. Traditionally, somatostatin analogs have been used for symptom control in patients with NETs.