Safety analysis data of concomitant telotristat ethyl (TE) plus peptide receptor radionuclide therapy (PRRT) in patients with metastatic/nonresectable neuroendocrine tumors (NETs) and carcinoid syndrome diarrhea (CSD) indicate that the safety profile of combination treatment was consistent with individual TE and PRRT therapies.
Telotristat ethyl is indicated for the treatment of CSD in combination with somatostatin analogs (SSAs) if inadequately controlled with SSAs alone; PRRT is recommended as second-line therapy after SSAs. At the 2020 North American Neuroendocrine Tumor Society Annual Symposium, the results of a safety analysis that examined the safety profile of TE + PRRT in patients with metastatic/nonresectable neuroendocrine tumors and CSD were reported.
Patients who were enrolled in the trials of the TE clinical program, including the phase 2 Study 202 (NCT00853047; N = 23), phase 2 Study 203 (NCT01104415; N = 15), the global phase 3 TELESTAR study (NCT01677910; N = 135), and the global phase 3 TELECAST study (NCT02063659; N = 76) were eligible for this analysis if they received concomitant PRRT. The study objective was to assess the treatment-emergent serious adverse events and elevations in hepatic enzymes relative to the start of PRRT.
A total of 24 patients who received TE and PRRT were included in the safety analysis; the median age was 64 years (range, 39-78 years). Within 180 days of initiating PRRT, 12 patients reported 17 serious adverse events. The timeline of treatment-emergent serious adverse events by day of onset were carcinoid crisis (day 2), vomiting (day 2), pyrexia (day 19), sciatica (day 27), bowel obstruction (day 28), elective hospitalization for PRRT (day 76), face wound (day 93), sleep apnea (day 118), bowel obstruction (day 137), syncope (day 137), and septicemia (day 179); all events were deemed unrelated to treatment. Two patients experienced adverse events of special interest (increased hepatic enzymes).
Results of this safety analysis indicate that the safety profile of patients who received concomitant TE and PRRT in the TE clinical program was consistent with that previously described for TE and PRRT individually, with no new safety signals emerging.
Source: Chauhan A, et al. North American Neuroendocrine Tumor Society 2020 Annual Symposium; October 1-3, 2020. Abstract C7.