Novartis has reported results from a Phase 3 study that reveal that pasireotide (SOM230) long-acting release (LAR) was effective at inducing full biochemical control compared to current standard medical therapy, Sandostatin LAR (octreotide/IM injection).
Pasireotide is an investigational multireceptor targeting somatostatin analog (SSA), which is approved in the EU for the treatment of adult patients with Cushing’s disease for whom surgery is not an option or for whom surgery has failed.
The Phase 3 pasireotide clinical trial, Pasport-Acromegaly, is a randomised double-blind study assessing the efficacy and safety of pasireotide LAR in 358 patients with active acromegaly.
In the study, patients were randomised to receive intramuscular injections of pasireotide LAR 40mg or octreotide LAR 20mg, every 28 days, for 12 months.
The primary endpoint of the trial was to compare the proportion of patients in the pasireotide LAR and octreotide LAR treatment arms with growth hormone (GH) <2.5µg/L and normal insulin-like growth factor (IGF-1) at 12 months. The secondary endpoints included comparison of the effect of pasireotide LAR and octreotide LAR on reduction of GH to <2.5µg/L alone and normalisation of IGF-1 alone.
Patients treated with pasireotide LAR were 63% more likely to achieve control of the disease than those on octreotide LAR and 31.3% of pasireotide LAR recipients achieved the primary endpoint compared to 19.2% of octreotide LAR recipients.
Novartis Oncology president Hervé Hoppenot said the positive results seen in the Phase 3 trial point to the potential role of pasireotide LAR in treating patients with acromegaly, a condition for which there remains an unmet need.
Acromegaly is a chronic hormonal disorder characterised by enlargement of the hands, feet and internal organs, as well as changes in facial structure.
The findings from the study were presented at the 2012 joint 15th International Congress of Endocrinology and 14th European Congress of Endocrinology meeting (ICE/ECE) in Florence, Italy.
Image: Novartis headquarters in Basel. Photo courtesy of: Andrew.