Results of ELECT® phase III study showed that treatment with Somatuline® resulted in a statistically significant reduction in the
number of days of rescue medication use versus placebo during the 16-week double-blind phase of the study
Safety data generated are consistent with known safety profile of Somatuline®
Ipsen announced that the results of the ELECT® phase III clinical study with Somatuline® Autogel® / Somatuline® Depot®
(lanreotide) Injection (hereafter referred to as Somatuline®)
Results of the ELECT® phase III study (poster 268) showed that treatment with Somatuline® 120 mg versus placebo resulted in a statistically significant reduction in the number of days in which immediate release octreotide was used as rescue medication, representing a mean difference of -14.8% (95%CI: -26.8, -2.8; p = 0.017). Somatuline® significantly improved the rates of complete/partial treatment success versus placebo (odds ratio = 2.4; 95%CI: 1.1, 5.3; p = 0.036).
Safety data collected during ELECT® study was consistent with known safety profile of Somatuline®. Somatuline® is approved for the treatment of symptoms associated with carcinoid syndrome in patients with neuroendocrine tumors in many markets worldwide; it is marketed as Somatuline® Autogel®, but not in the US, where it is marketed as Somatuline® Depot® for acromegaly only. As such, data arising from the ELECT® study can be considered as an investigational use of Somatuline®
Depot® in the United States.
Claude Bertrand, Executive Vice-President, Research & Development and Chief Scientific Officer of Ipsen stated: “The results observed in the multinational ELECT® study add to the body of evidence evaluating the efficacy and safety of Somatuline® in the control of symptoms in GEP-NET patients with carcinoid syndrome. Along with the recently reported CLARINET® results demonstrating the antiproliferative effect of Somatuline®, ELECT results represent new data to document the efficacy and safety of Somatuline® in gastroenteropancreatic neuroendocrine tumors.”
Edward M. Wolin, MD, Co-Director, Carcinoid and Neuroendocrine Tumor Program Medical Oncology, Samuel Oschin Cancer Center, Cedars-Sinai (USA) stated: “In the ELECT® study, rescue medication with immediate release formulation of octreotide was allowed for all patients in the Somatuline® and placebo arms when needed to control their symptoms. This study demonstrated a decreased use of octreotide as rescue medication in patients treated with Somatuline® 120mg when compared to those receiving placebo (both naïve to treatment or previously treated with a somatostatin analogue).”