Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), announced today additional data on XERMELO’s® (telotristat ethyl) antiproliferative effects in patients with carcinoid syndrome that were presented at the European Neuroendocrine Tumor Society (ENETS) meeting (March 11-13). XERMELO is approved for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy, but is not currently approved for any other use.
Data from a retrospective, pre- and post-design chart review of 200 metastatic neuroendocrine tumor patients who were on standard background therapies and received telotristat ethyl for an average of 12 months in US clinical practice demonstrated that most patients had no tumor progression at 6, 12 and 18 months following initiation of telotristat ethyl, with a median time to tumor progression (TTP) of 39.8 months. The majority of patients also experienced progression-free survival (PFS) in the post-telotristat ethyl period, with a median PFS of 23.7 months. In addition, in a subset of 22 patients with recorded biomarker data, mean serotonin levels decreased significantly in the post-telotristat ethyl period. Patients also improved on carcinoid syndrome (CS) symptoms, body weight and performance status.
“We are pleased this observational study showed that use of telotristat ethyl was associated with not only neuroendocrine tumor control but also meaningful improvements in CS symptoms and clinical indicators of overall health in patients with advanced neuroendocrine tumors and carcinoid syndrome,” said Pablo Lapuerta, executive vice president and chief medical officer of Lexicon. “Results of this observational study coupled with preclinical data support the conduct of clinical trials to examine telotristat ethyl’s effect on neuroendocrine tumors.”