Ipsen announces at ASCO GI that ELECT® clinical trial of Somatuline® in the control of symptoms in GEP-NET1 patients with carcinoid syndrome met its primary endpoint
Paris (France), 17 January 2014 – Ipsen (Euronext: IPN; ADR: IPSEY) today announced that the results of the ELECT ® phase III clinical study with Somatuline ® Autogel ® / Somatuline ® Depot ® (lanreotide) Injection (hereafter referred to as Somatuline ® ) will be presented on Friday 17 January 2014 at the Gastrointestinal Cancers Sy mposium, San Francisco, CA, USA.
Results of the ELECT ® phase III study (poster 268) showed that treatment with Somatuline ® 120 mg versus placebo resulted in a statistically signifi cant reduction in the number of days in which immediate release octreotide was used as rescue medica tion, 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.
Posted: January 2014