The U.S. affiliate of Ipsen (Euronext: IPN; ADR: IPSEY) today announced that the New England Journal of Medicine has published clinical trial results showing that Somatuline® Autogel® / Somatuline® Depot® (lanreotide) Injection 120 mg (referred to as Somatuline®) achieved statistically significant prolongation of progression free survival (PFS) over placebo in patients with metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs). CLARINET®, an investigational Phase III randomized, double-blind, placebo-controlled study of the antiproliferative effects of Somatuline® was conducted in 48 centers across 14 countries. The article titled “Lanreotide in Metastatic Enteropancreatic Neuroendocrine Tumors” is available online at NEJM.org and has been published in the July 17th edition (N. Engl. J. Med. 2014; 371: 224-233).
The data gathered from 204 GEP-NET patients over the 96-week study showed that placebo-treated patients had a median PFS of 18.0 months and 33.0% had not progressed or died at 96 weeks, whereas the median PFS for Somatuline® treated patients was not reached and 65.1% had not progressed or died at 96 weeks (stratified logrank test, p<0.001). This represented a 53% reduction in risk of disease progression or death based on a hazard ratio of 0.47 (95% CI: 0.30–0.73). These statistically and clinically significant antiproliferative effects of Somatuline® were observed in a large population of patients with grade G1 or G2 (World Health Organization classification) GEP-NETs, and independent of hepatic tumor volume (≤25% or >25%). Quality of life measures were not different between the Somatuline® and placebo groups. Safety data generated from the study are consistent with the known safety profile of Somatuline®.
“The CLARINET® data are compelling, since no similar GEP-NET progression free survival data exist for a somatostatin analog in such a large, multinational study population,” said Dr. Martyn Caplin, Professor of Gastroenterology & Gastrointestinal Neuroendocrinology, Royal Free Hospital (London, UK) and lead author and principal investigator of the CLARINET® study.
“The peer-reviewed publication of CLARINET® results in the New England Journal of Medicine highlights the robust data that showed an antiproliferative effect of Somatuline® in the treatment of GEP-NETs,” said Claude Bertrand, Executive Vice President R&D and Chief Scientific Officer. “Based on these significant results, Ipsen has initiated a worldwide registration program and on July 1st 2014, the submission of a Supplemental New Drug Application for Somatuline® for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to the U.S. FDA as well as Marketing Authorization variations in 25 countries of the European Union were announced.”
“This is potentially exciting news for physicians treating GEP-NETs, as the data showed anti-tumor activity and a delay in disease-progression in patients treated with Somatuline® Depot®,” said Dr. Alexandria Phan, CLARINET investigator, Director of GI Medical Oncology at Houston Methodist Cancer Center.
The data from CLARINET® is considered investigational, as Somatuline® is not indicated for anti-proliferative treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in any market. Somatuline® is approved for treatment of symptoms associated with neuroendocrine tumors, which can include the treatment of GEP-NET patients experiencing symptoms from carcinoid syndrome, in many markets where it is marketed as Somatuline® Autogel®. Somatuline® is not approved in the U.S. to treat GEP-NETs or the symptoms thereof, where it is marketed as Somatuline® Depot® for acromegaly.