Ipsen reports mixed Ph III results with Somatuline Autogel in patients with acromegaly

French drugmaker Ipsen (Euronext: IPN) announced the results of an international Phase IIIb study, PRIMARYS, assessing an investigational use of Somatuline Autogel (lanreotide) 120mg as first line therapy in newly diagnosed acromegaly patients with a macroadenoma, reporting mixed results. Somatuline is already approved and marketed for acromegaly, and generated sales of 225 million euros ($300 million) in 2012.

While PRIMARYS did not meet statistical significance with respect to its primary efficacy endpoint, investigators observed clinically relevant tumor volume reductions, in a majority of patients. Data from secondary biomarker endpoints of growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels were further supportive of these findings. Baseline GH level was the main factor identified as potential predictor for tumor response to primary therapy.

PRIMARYS is the first study of a somatostatin analogue in such a large and homogeneous population (90 treatment-naive acromegalic patients with macroadenoma) to evaluate tumor volume reduction as the primary endpoint using magnetic resonance imaging (MRI) with a very robust and unique methodology for central assessment.