Results of phase III trial of Somatuline Depot (lanreotide) in neuroendocrine tumour carcinoid syndrome published in Endocrine Practice- Ipsen Biopharmaceuticals

Ipsen Biopharmaceuticals announced that Endocrine Practice has published Phase III clinical trial results examining the efficacy and safety of Somatuline Depot (lanreotide) Injection 120 mg (referred to as Somatuline) in patients with carcinoid syndrome. In the 16-week, Phase III randomized, double-blind, placebo-controlled study of the efficacy and safety of Somatuline in patients with carcinoid syndrome,115 patients were randomized to Somatuline 120mg or placebo every four weeks, with access to short-acting octreotide as rescue medication.

The study showed the adjusted mean percentage days with rescue octreotide use (the primary endpoint) was lower in the Somatuline group (33.7 percent) versus the placebo group (48.5 percent). The odds ratio of full or partial treatment success (defined as three or fewer days of short-acting octreotide use in weeks 12 to 15) was significantly greater with Somatuline than placebo (2.4). The most common Adverse Events observed in the study were nausea, vomiting, abdominal pain, and flatulence.