Somatuline Clarinet Phase III study Ipsen published online in NEJM -
The US subsidiary of Ipsen (Euronext: IPN, ADR: IPSEY) announced aujourd 'hui the New England Journal of Medicine published the results of clinical trials showing that Somatuline ® Autogel ® / Somatuline ® Depot ® (lanreotide) injection 0 mg (referred Somatuline ® ) achieved a statistically significant prolongation of progression free survival (PFS) compared to placebo in patients with metastatic neuroendocrine gastroenteropancreatic tumors (GEP-NETs ). Clarinet ® , an experimental phase III randomized, double-blind, placebo-controlled anti-proliferative effects of Somatuline ® was conducted in 48 centers in 14 countries. The article "lanreotide in metastatic neuroendocrine tumors Enteropancreatic" is available online at NEJM.org and was published in July 17 edition (N Engl J Med 2014; 371: 224-233 ..)
data collected from 204 GEP-NET patients on the 96-week study showed that patients treated with placebo had a median PFS of 18.0 months and 33.0% has not progressed or died at 96 weeks, while the median PFS for Somatuline ® of patients was not reached and 65.1% had not progressed or died at 96 weeks (stratified log-rank test, p <0.001 .) This represents a 53% reduction in risk of disease progression or death based on a hazard ratio of 0.47 (95% CI 0.30 to 0.73) These statistically effects. and clinically significant antiproliferative Somatuline ® were observed in a broad population of patients with grade G1 or G2 (classification of the World Health Organization) GEP-NETs, and independent of tumor volume liver (≤25% or> 25%). Quality of life measures were not different between Somatuline ® groups and placebo. The safety data generated by the study are consistent with the known safety profile of Somatuline ® .
"The Clarinet ® The data are convincing because no progression similar GEP-NET there are survival data without a somatostatin analogue in a large population studied multinational" said Dr Martyn Caplin, Professor of gastroenterology and gastrointestinal neuroendocrinology, Royal free Hospital (London, UK) and lead author and principal investigator of the Clarinet ® study.
"published peer-CLARINET ® results in the New England Journal of Medicine highlights the robust data that showed an anti-proliferative 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 launched a registration program in the world and the July 1, 2014, the presentation of a supplementary New Drug Application for Somatuline ® for the treatment of neuroendocrine tumors gastroenteropancreatic (GEP-NET) to the FDA and the variations marketing authorization in 25 countries EU were announced. "
" These are potentially interesting news for physicians GEP-NET, data have shown anti-tumor activity and a delay in disease progression in patients treated with Somatuline ® Depot ® , "said Dr. Alexandria Phan, Clarinet researcher, IM Director medical oncology at Houston Methodist Cancer Center.
the data Clarinet ® is considered experimental, as Somatuline ® are not indicated for the anti-proliferative treatment of neuroendocrine gastroenteropancreatic tumors (GEP-NET) in a market. Somatuline ® is approved for treatment symptoms associated with neuroendocrine tumors, which may include the treatment of GEP-NET patients with symptoms of carcinoid syndrome in many markets where it is marketed as Somatuline ® Autogel ® . Somatuline ® is not approved in the US to treat GEP-NETs or symptoms thereof, where it is marketed as Somatuline ® Depot ® of acromegaly.
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