Date: 2014-05-05
Type of information: Presentation of results at a congress
phase: 3
Announcement: presentation of results at the 16th European Congress of Endocrinology
Company: Novartis (Switzerland)
Product: Signifor® LAR (pasireotide long-acting release; SOM230)
Action
mechanism: Pasireotide (SOM230) is an investigational multireceptor targeting somatostatin analog (SSA) that binds with high affinity to four of the five somatostatin receptor subtypes (sst 1, 2, 3 and 5). Pasireotide is approved in the EU as Signifor® for the treatment of adult patients with Cushing\'s disease for whom surgery is not an option or for whom surgery has failed.
Disease: acromegaly
Therapeutic area: Hormonal diseases - Rare diseases - Endocrine diseases
Country:
Trial
details: The multicenter Phase III study was a randomized, double-blind trial examining pasireotide LAR 40 mg or pasireotide LAR 60 mg versus continued open-label treatment with octreotide LAR 30 mg or lanreotide Autogel 120 mg (the control group) for 24 weeks. The trial included 198 patients with inadequately controlled acromegaly on maximum approved doses of octreotide LAR or lanreotide Autogel for at least 6 months, regardless of prior surgical status. The primary endpoint of this study was the proportion of patients achieving biochemical control as measured by the mean GH levels of The key secondary endpoint was the percentage of patients achieving normalized IGF-1; other secondary endpoints included the percentage of patients achieving normalized GH levels, tumor reduction and safety.
Latest
news: * On May 5, 2014, Novartis has presented results from a pivotal Phase III trial of 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. Worldwide regulatory filings for pasireotide LAR in acromegaly are currently underway based on these results and separate previously published robust Phase III data.
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 hyperglycemia in the pasireotide LAR arm. The key secondary endpoint was the percentage of patients achieving normalized IGF-1; other secondary endpoints included the percentage of patients achieving normalized GH levels, tumor reduction and safety. Notably, in this study, IGF-1 normalization was achieved by 24.6% and 26.2% of patients taking pasireotide LAR 40 mg and 60 mg, respectively (95% CI, 14.8-36.9; P<0.001; 95% CI, 16.0-38.5; P<0.001) and was not achieved by any patients in the control arm (95% CI, 0-5.3). Additionally, 35.4% and 43.1% of patients in the pasireotide LAR 40 mg and 60 mg arms, respectively (95% CI, 23.9-48.2; 95% CI, 30.8-56.0) had mean GH levels of
