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news.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.
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The Phase III trial results demonstrated that patients administered with 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.
Novartis Oncology ad interim president and Oncology Development and Medical Affairs global head Alessandro Riva noted that these results strengthen the company’s understanding of this rare endocrine disorder and suggest pasireotide LAR may offer benefit for acromegaly patients whose disease is not fully controlled on their current therapy.
"As part of our long-standing commitment to transforming the care of rare pituitary diseases, we are working to bring this potentially meaningful solution to the acromegaly community," Riva added.
Worldwide regulatory filings for pasireotide LAR in acromegaly are currently underway based on these results and separate previously published robust Phase III data.
Pasireotide LAR 40mg and 60mg has been evaluated in the multicenter Phase III study against continued therapy with octreotide LAR 30mg or lanreotide Autogel 120mg for 24 weeks in patients who did not achieve GH and IGF-1 biochemical control despite receiving the maximum approved doses of these currently available somatostatin analogues.
The randomized, double-blind trial enrolled 198 patients with inadequately controlled acromegaly on maximum approved doses of octreotide LAR or lanreotide Autogel for at least six months, regardless of prior surgical status.
Proportion of patients achieving biochemical control was the primary endpoint of this study, while the key secondary endpoint was the percentage of patients achieving normalized IGF-1. The other secondary endpoints included the percentage of patients achieving normalized GH levels, tumor reduction and safety.
The most common adverse events observed with pasireotide LAR 40mg, 60mg and the control arm include hyperglycemia, diabetes mellitus and diarrhea.
Novartis has presented the Phase III trial at the 16th European Congress of Endocrinology.