Somatuline increased progression-free survival over placebo in patients with metastatic gastroenteropancreatic neuroendocrine tumors in a randomized phase III trial.
CLARINET, a double-blind, placebo-controlled study of the antiproliferative effects of Somatuline (lanreotide) Injection 120 mg was conducted in 48 centers across 14 countries.
The data was published in the New England Journal of Medicine, in an article titled “Lanreotide in Metastatic Enteropancreatic Neuroendocrine Tumors.”
The data gathered from 204 GEP-NET patients showed that placebo-treated patients had a median PFS of 18.0 months and 33.0 percent had not progressed or died at 96 weeks, whereas the median PFS for Somatuline treated patients was not reached, and 65.1 percent had not progressed or died in the same time (stratified logrank test, p<0.001).
This represented a 53 percent reduction in risk of disease progression or death based on a hazard ratio of 0.47 (95% CI: 0.30–0.73). These effects were observed in a population of patients with World Health Organization classification G1 or G2 GEP-NETs, and independent of hepatic tumor volume.
Quality of life measures were not different between the Somatuline and placebo groups, and safety data was 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 analogue in such a large, multinational study population,” said Martyn Caplin, professor of gastroenterology and gastrointestinal neuroendocrinology at the Royal Free Hospital in London, and lead author and principal investigator of the study.
Based on the results of the trial, Ipsen, the drug’s sponsor, began a worldwide registration program, and submitted regulatory filings with FDA and for marketing authorization in the European Union.
Somatuline is not indicated for anti-proliferative treatment of gastroenteropancreatic neuroendocrine tumors in any market. It 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. The active substance in Somatuline Depot is lanreotide acetate, a somatostatin analogue that inhibits the secretion of several endocrine, exocrine and paracrine functions.
