Clinical Data. In clinical studies, cabozantinib has been evaluated in multiple tumor types including medullary thyroid cancer, castration-resistant prostate cancer, ovarian cancer, breast cancer, hepatocellular carcinoma, nonsmall cell lung cancer, melanoma, differentiated thyroid cancer, renal cell carcinoma, and glioblastoma multiforme. To date, cabozantinib has demonstrated a broad spectrum of clinical activity in these tumor types and has been approved for the treatment of progressive metastatic medullary thyroid carcinoma, hepatocellular carcinoma, renal cell carcinoma. Consult the Investigator’s Brochure of the drug for more details. (1)
Clinical Data. The safety and efficacy of lanreotide has been demonstrated in subjects with acromegaly or GEP NETs. Different formulations of lanreotide (including lanreotide Autogel 120 mg every 28 days) also produced similar results in other indications including cardiac disorders, GI bleeding, diabetes, thyrotropic adenoma, digestive fistulae, ophthalmic Graves disease and paediatric studies, where the types and percentages of related serious adverse events (SAEs) across indications were broadly similar and no specific safety concerns were identified. A phase III/IV, double-blind study (ELECT trial) assessed the efficacy of lanreotide administered at the dose of 120 mg every 28 days for the control of symptoms associated with NETs (diarrhoea and/or flushing). Least squares (LS) mean percentage of days on which s.c. octreotide was administered as rescue medication during the double-blind (DB) phase as a surrogate for symptom control, was significantly lower in favour of the lanreotide group (33.72% of days) compared with the placebo group (48.49% of days) (p=0.0165). The absolute difference in LS means (95% CI) was –14.76% (- 26.78%, -2.75%). Results of the subgroup analyses confirmed the consistency of the results of primary efficacy variable. There was a reduction in mean percentage of days in which deep s.c. octreotide was administered as rescue medication irrespective of age, gender, race, ethnicity, time since diagnosis and BMI (except for BMI>30) supporting the robustness of the primary efficacy analysis. No statistically significant changes in QoL measures were reported; modest improvements in global health status (EORTC- QLQ-C30) and GI and endocrine symptoms were observed for the lanreotide group compared with the placebo group. For biochemical markers, subjects treated with lanreotide showed reductions from baseline in median values of CgA and 5-HIAA, while these biomarkers had increases in median values in the placebo group. Overall, the results demonstrated that subjects who received lanreotide required octreotide, as rescue medication to treat the symptoms of carcinoid syndrome, for significantly fewer days compared subjects who placebo. These results indicate that lanreotide is beneficial in reducing rescue medication usage to control symptoms associated with NETs. An international, non-interventional, cross-sectional phase IV study (SYMNET trial) has been conducted to assess NET subjects currently treated by lanreotide for history of carcinoid syndrome a...