PASPORT-CUSHINGS (PASireotide clinical trial PORTfolio – CUSHING’S disease), a randomised study to evaluate a medical therapy in patients with Cushing’s disease, is part of a large-scale global clinical development program to assess the efficacy and safety of SOM230 in a range of pituitary and neuroendocrine tumors.
At six months, the majority of evaluable patients (91/103) experienced a reduction from baseline in urinary free cortisol (UFC) levels, the main measure of biochemical control of the disease.
UFC levels were normalised in 26% of patients randomised to SOM230 900µg twice daily, meeting the primary endpoint of the study.
Novartis said that on average, as UFC levels were reduced, clinical symptoms of Cushing’s disease improved including reduction of blood pressure, total cholesterol, weight and body mass index (BMI).
One of the study investigators Annamaria Colao said that the study findings show that SOM230 has the potential to directly target the underlying pituitary tumor and suppress cortisol production, thereby helping patients achieve biochemical control of their Cushing’s disease and the associated debilitating symptoms.
Novartis Oncology president Herve Hoppenot said that positive results from the trial bring them one step closer to providing physicians with a new treatment option to offer people living with the physically and emotionally debilitating symptoms associated with Cushing’s disease.
Novartis said that the results from the trial will form the basis for the first regulatory filing of SOM230 planned this year.