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July 17, 2014
05:21 EDTIPSEYIpsen Somatuline CLARINET Phase III results published in NEJM
Ipsen announced that the New England Journal of Medicine, or NEJM, has published clinical trial results showing that Somatuline Autogel/Somatuline Depot Injection 120 mg achieved statistically significant prolongation of progression free survival over placebo in patients with metastatic gastroenteropancreatic neuroendocrine tumors, or 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” has been published in the July 17 edition. 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. This represented a 53% reduction in risk of disease progression or death based on a hazard ratio of 0.47. These statistically and clinically significant antiproliferative effects of Somatuline were observed in a large population of patients with grade G1 or G2 GEP-NETs, and independent of hepatic tumor volume. 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.
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