Somatuline Depot: Additional Phase III data

Additional data from the double-blind, international Phase III ELECT trial in 115 patients with neuroendocrine tumors associated with carcinoid syndrome showed that subcutaneous 120 mg Somatuline Depot every 4 weeks reduced the percentage of days that subcutaneous octreotide was required as rescue medication to control symptoms associated with carcinoid syndrome through week 16, the primary endpoint, by 14.8% vs. placebo (34% vs. 49%, p=0.017). However, the company said the observed absolute difference between treatment arms was less than the 30% of days that was deemed clinically meaningful. The study was designed to have 90% power to detect a treatment difference of 30%.

Additionally, a significantly greater proportion of patients receiving Somatuline Depot achieved a complete (40.7% vs. 23.2%) or partial (6.8% vs. 5.4%) treatment success vs. placebo (p=0.036). Complete and partial successes were defined respectively as no need for or <=3 days of use of octreotide as rescue medication between weeks 12 and 15. The trial consisted of a 16-week double-blind, placebo-controlled portion followed by a 32-week open-label extension phase. Data were presented at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium in San Francisco. Last September, Ipsen reported top-line data from ELECT showing that Somatuline Depot met the primary endpoint (see BioCentury, Sept. 23, 2013). ...