Phase III study success for Signifor LAR for Acromegaly - Novartis

Novartis presented results from a pivotal Phase III trial of investigational therapy Signifor LAR (pasireotide LAR; SOM230) in patients with Acromegaly for whom current standard of care provides inadequate disease control. The study findings showed that patients taking pasireotide long-acting release (LAR) achieved greater disease control when compared to continued treatment with the standard somatostatin analogue therapies, octreotide LAR or lanreotide Autogel. These data were presented at the 16th European Congress of Endocrinology.

This study evaluated pasireotide LAR 40 mg and 60 mg against continued therapy with octreotide LAR or lanreotide Autogel in patients who did not achieve GH and IGF-1 biochemical control despite receiving the maximum approved doses of these currently available somatostatin analogues (SSAs). In the trial, significantly more patients achieved biochemical control with each dose of pasireotide LAR compared to the octreotide LAR and lanreotide Autogel control arm. Specifically, 15.4% and 20.0% of those with inadequately controlled acromegaly taking pasireotide LAR 40 mg and 60 mg, respectively (95% confidence interval [CI], 7.6-26.5; P=0.0006; 95% CI, 11.1-31.8; P<0.0001), achieved biochemical control versus 0% achieving biochemical control on continued treatment with octreotide lar or lanreotide autogel (95% ci, 0-5.3). the incidence and severity of adverse events (aes) was similar across all treatment groups, except for a higher frequency and degree of hyperglycaemia in the pasireotide lar arm.>