Signifor LAR pasireotide: Phase III data

A double-blind, international Phase III trial in 198 patients with inadequately controlled acromegaly showed that 40 and 60 mg Signifor LAR given every 4 weeks for 24 weeks each met the primary endpoint of a greater proportion of patients achieving biochemical control as measured by mean GH levels of <2.5 µg/L and normalized IGF-1 at week 24 vs. continued open-label treatment with 30 mg Sandostatin LAR octreotide or 120 mg Somatuline Depot given every 4 weeks for at least 6 months (15.4% and 20%, respectively, vs. 0%, p=0.0006 and p<0.0001). Low- and high-dose Signifor LAR also met the secondary endpoint of a greater proportion of patients achieving normalized IGF-1 vs. Sandostatin LAR or Somatuline Depot (24.6% and 26.2%, respectively, vs. 0%, p<0.001 for both). A greater proportion of patients receiving low- and high-dose Signifor LAR also achieved mean GH levels of <2.5 µg/L (35.4% and 43.1%, respectively, vs. 13.2%) and a >25% reduction in tumor size (18.5% and 10.8%, respectively, vs. 1.5%) vs. Sandostatin LAR or Somatuline Depot. Data were presented at the European Congress of Endocrinology in Wroclaw. ...