Results of the TELEPRO-II study showed that telotristat ethyl (TE) treatment resulted in significant, clinically relevant improvements across carcinoid syndrome (CS) symptoms in a real-world setting.
Telotristat ethyl is an oral tryptophan-hydroxylase inhibitor approved to treat carcinoid syndrome diarrhea (CSD) in combination with somatostatin analogs (SSAs) in adults with CSD inadequately controlled with SSAs alone. At the 2020 North American Neuroendocrine Tumor Society Annual Symposium, findings from the TELEPRO-II study, a real-world study evaluating the effectiveness of TE for the treatment of CS symptoms during the second year of the drug’s availability in the United States, were reported.
Eligible patients enrolled in the TELEPRO-II study participated in a nurse support program and reported CS symptoms monthly after starting TE for up to 3 months. CS symptoms included number of bowel movements (BMs) per day, flushing episodes per day, stool consistency on a scale of 1 (very hard) to 10 (watery), urgency to defecate, nausea, and abdominal pain on a scale of 0 (not at all) to 10 (worst imaginable).
Of the 1603 patients who initiated TE, 684 patients were enrolled in the TELEPRO-II study. The majority of patients enrolled were female (55%), and 50% were aged ≥65 years; 56% of patients were receiving long-acting octreotide. At baseline, symptom burden of the study cohort was high, with 6.26 (standard deviation [SD], 29) mean BMs daily, 3.04 (SD, 3.20) mean daily flushing episodes, mean score of 6.6 (SD, 1.99) in stool consistency, mean score of 8.16 (SD, 2.25) in urgency severity, mean score of 8.44 (SD, 2.91) in nausea severity, and mean score of 6.51 (SD, 3.16) in abdominal pain.
Following initiation of TE, patients reported significant improvements across all CS symptoms at month 3 compared with baseline, including in daily BM frequency (–3.99), daily flushing episodes (–2.2), stool consistency (–3.66), nausea severity (–6.16), abdominal pain (–4.72), and urgency severity (–5.42). Patients with <30% BM reduction also showed improvements in non-diarrhea–related CS symptoms.
Results of the TELEPRO-II study in a large, real-world patient population showed significant, clinically relevant improvements across CS symptoms with TE treatment.
Source: Kulke M, et al. North American Neuroendocrine Tumor Society 2020 Annual Symposium; October 1-3, 2020. Abstract C4.
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