Phase III results from ELECT study (NIH, 28 August 2013)

The results from ELECT, a double-blind, randomized placebo controlled clinical trial investigating the efficacy and safety of Somatuline® Depot (lanreotide) injection to treat carcinoid syndrome, were presented at GI ASCO this month.

The study consisted of a 16-week, double-blind, randomized placebo-controlled phase followed by an initial 32-week open-label phase. Throughout the study the patients were allowed to use rescue medication in the form of subcutaneous somatostatin analogues (octreotide) to control their symptoms. The primary endpoint was the percentage of days subcutaneous octreotide was required to control symptoms associated with carcinoid syndrome, as rescue medication during the 16-week double-blind phase of the study. Secondary endpoints included frequency of diarrhoea and flushing, usage of other rescue medication, quality of life, tumour markers and safety.

ELECT® met its primary endpoint by demonstrating that the percentage of days in which octreotide was used as rescue medication during the 16-week double blind period was significantly lower in the Somatuline® group than in the placebo group [representing a mean difference of -14.8% (95%ci:-26.8)(95%ci:-2.8)(95%ci:p = 0.017). A significantly greater proportion of patients in the Somatuline® arm experienced complete (40.7% vs. 23.2%, respectively) or partial (6.8% vs. 5.4%, respectively) success when compared to the placebo treatment. As a result, Somatuline® significantly improved chances of having either a complete or a partial treatment success versus placebo (OR = 2.4; 95%CI: 1.1, 5.3; p = 0.036). “Complete success” and “partial success” were defined, respectively, as no need for, or less-than or equal to 3 days of, use of octreotide as rescue medication between weeks 12 and 15. The need for >3 days of octreotide between weeks 12 and 15 was defined as treatment failure.

Safety data generated from the study were consistent with the known safety profile of Somatuline®. The incidence of treatment emergence adverse events (AEs), including treatment related AEs, was similar between groups in all phases of the study.

Treatment-emergent serious AEs were uncommon occurring in 3.4% of the Somatuline® group and 8.8% of the placebo group.

Source: National Institute of Health (clinical trial)