The FINANCIAL — Results of the largest Phase III study of acromegaly patients show the novel therapy pasireotide long-acting release (LAR), was significantly more effective at inducing full biochemical control compared to the current standard medical therapy, Sandostatin LAR.
These data were presented at the 2012 joint 15th International Congress of Endocrinology and 14th European Congress of Endocrinology meeting (ICE/ECE) in Florence, Italy.
Acromegaly is a rare endocrine disorder characterized by enlargement of the hands, feet and internal organs, as well as changes in facial structure. According to Novartis, the majority of acromegaly cases are caused by a non-cancerous tumor in the pituitary gland that secretes excess growth hormone (GH), leading to elevated levels of insulin like growth factor (IGF-1).
The study met its primary endpoint, with significantly more patients treated with pasireotide LAR (31.3%) experiencing full control of their disease (defined as the combination of both GH <2.5µg/L and age- and sex-matched normalized IGF-1 levels) than those taking octreotide LAR (19.2%) (p=0.007). Patients treated with pasireotide LAR were 63% more likely to achieve control of their disease than those on octreotide LAR. The safety profile of pasireotide LAR was similar to that of octreotide LAR with the exception of a higher degree of hyperglycemia.
Growth hormone and IGF-1 levels are typically used to determine control of the disease with the most commonly used standard medical therapy, somatostatin analogs. Currently, only 20-25% of acromegaly patients naïve to previous somatostatin analog treatment achieve full control over their disease when treated with current somatostatin analogs, as measured by these two levels.
"While Sandostatin LAR is an effective treatment, inadequate control of GH and IGF-1 remains an issue for many patients with acromegaly and new therapeutic approaches are needed for these patients to better control their disease," said Annamaria Colao, MD, lead study investigator and Professor of Endocrinology, Chief of the Neuroendocrine Unit at the Department of Molecular and Clinical Endocrinology and Oncology, Federico II University of Naples. "We are very encouraged by the findings of this study, the largest ever in this population, which found that pasireotide LAR provided full control in nearly a third of study participants."
Investigators also presented data from a 6-month extension study, where paftients who did not achieve full biochemical control after 12 months on therapy could switch to the other treatment. After an additional 6 months of treatment, 21% of the 81 patients who switched to pasireotide LAR achieved full control of their disease. By contrast, of the 38 patients who switched to octreotide LAR, 2.6% achieved full control.
"The positive results seen in the Phase III trial point to the potential role of pasireotide LAR in treating patients with acromegaly, a condition for which there remains an unmet need," said Hervé Hoppenot, President, Novartis Oncology. "These findings are welcome news as we continue our research efforts to discover treatments for patients with pituitary-related conditions."
In addition to acromegaly, Novartis is committed to studying other pituitary-related conditions including continued study in Cushing's disease. Data also presented at this meeting include long-term follow-up results from the Phase III registrational trial which led to the recent EU approval of Signifor (pasireotide) for the treatment of Cushing's disease. Additionally, researchers presented data from a Phase I proof-of-concept trial for the investigational 11β-hydroxylase inhibitor, LCI699, in Cushing's disease.
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