Ipsen reports positive results from phase III CLARINET study of Somatuline Autogel

11th July 2013 (Last Updated July 11th, 2013 18:30)

Pharmaceutical company Ipsen has reported positive results from a phase III controlled study of lanreotide antiproliferative response in neuroendocrine tumours (CLARINET) of Somatuline Autogel 120mg in gastrointestinal and pancreatic neuroendocrine tumours (GEP-NETs).

Small intestine neuroendocrine tumour

Pharmaceutical company Ipsen has reported positive results from a phase III controlled study of lanreotide antiproliferative response in neuroendocrine tumours (CLARINET) of Somatuline Autogel 120mg in gastrointestinal and pancreatic neuroendocrine tumours (GEP-NETs).

Treatment with Somatuline Autogel 120mg demonstrated statistically significant improvement in progression-free survival compared to a placebo with a consistent safety profile to that of Somatuline.

The first large-scale, placebo-controlled, randomised CLARINET study demonstrated the anti-tumoral activity of a somatostatin analogue in non-functioning GEP-NETs.

CLARINET principal investigator and Royal Free Hospital gastroenterology and gastrointestinal neuroendocrinology professor Dr Martyn Caplin said that this first study inclusive of GEP-NETs provides clear evidence that Somatuline Autogel 120mg delays tumour progression or death.

"These important results will help the medical community to confirm the place of Somatuline Autogel in the treatment algorithm of these patients," he said.

Ipsen chief scientific officer and Research & Development executive vice-president Claude Bertrand said: "We believe it should meet the expectations of physicians by potentially providing a new treatment option for patients with gastrointestinal and pancreatic neuroendocrine tumours."

The multinational study conducted two baseline computed tomography scans, followed by additional scans at intervals up to 96 weeks.


Image: High magnification micrograph of a small intestine neuroendocrine tumour. H&E stain. Photo: Nephron.