A researcher at Moffitt Cancer Center and his international team of colleagues have reported study results on a novel multireceptor-targeted somatostatin analogue called pasireotide (SOM230) manufactured by Novartis Pharma AG. The Phase II, open-label, multicenter study in patients with advanced neuroendocrine tumors (NET) whose symptoms were no longer responsive to octreotide LAR therapy found that the drug was effective and well tolerated in controlling patient symptoms.
The study results are reported in a recent issue of Endocrine-Related Cancer, a publication of the Society for Endocrinology.
"Neuroendocrine tumors are often asymptomatic and, by the time of diagnosis, have frequently metastasized, usually to the liver," said the study's corresponding author, Larry K. Kvols, M.D., a senior member at Moffitt and section head of neuroendocrine oncology. "Surgery is essential in managing metastatic NET and can be curative for early disease, but the majority of patients need further treatment."
According to Kvols, octreotide and lanreotide, drugs that mimic natural somatostatin, have been "the mainstay" for symptom management of neuroendocrine tumors. However, many patients eventually fail to respond to this treatment and have poor prognoses.
"Pasireotide is a novel multireceptor-targeted somatostatin analogue that binds to four of the five known somatostatin receptor subtypes," said Kvols, whose research is in experimental therapies for neuroendocrine cancer. "Because of its binding ability, it may offer symptom reduction for patients who have eventually failed to respond to traditional therapy."
The multicenter clinical trial, conducted at sites in the United States and Europe, enrolled 89 patients and evaluated 44 for efficacy and 45 for tolerability. Pasireotide "effectively controlled symptoms." Evaluation of tumor response in 23 patients showed 13 with stable disease and 10 with progressive disease. The drug was "effective and well-tolerated" and adverse events, most commonly gastrointestinal, were "mild or moderately severe."
The study was funded in part through funding by Novaratis Pharmaceuticals.
A Phase III study evaluating pasireotide versus octreotide is ongoing for patients with advanced NET whose disease-related symptoms have been inadequately controlled.
- L. Kvols, K. E. Oberg, T. O'Dorisio, P. Mohideen, W. W. de Herder, R. Arnold, K. Hu, Y. Zhang, G. Hughes, L. Anthony, B. Wiedenmann. Pasireotide (SOM230) shows efficacy and tolerability in the treatment of patients with advanced neuroendocrine tumors refractory or resistant to octreotide LAR: results from a Phase II study. Endocrine Related Cancer, 2012; DOI: 10.1530/ERC-11-0367
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