Abstract Library

#1354 Patient Interviews in TELESTAR, a Phase 3 Study of Telotristat Etiprate, Report Meaningful Improvement in Carcinoid Syndrome

Introduction: Telotristat etiprate (TE) reduces serotonin production. In TELESTAR, a phase 3 study in patients (pts) with carcinoid syndrome (CS) on somatostatin analogues with ≥4 bowel movements (BM) per day, TE significantly reduced BM frequency (freq). Overall (n=135), durable response (DR, ≥30% reduction in BMs/day for ≥50% of the study period) was observed in 44% (250 mg tid) and 42% (500 mg tid), vs 20% on placebo (PBO); p≤0.02 for each TE vs. PBO. A subset with similar demographics to the overall trial was interviewed.

Conference: 13th Annual ENETSConcerence (2016)

Presenting Author:

Authors: Pavel M, Hörsch D, Anthony L, Ervin C, Kulke M,

Keywords: serotonin, bowel movement, durable response, treatment satisfaction,

#1333 Efficacy and Safety of Telotristat Etiprate in Patients with Carcinoid Syndrome not Adequately Controlled by Somatostatin Analog Therapy: Analysis of the Ongoing TELESTAR Extension Period

Introduction: TELESTAR was a pivotal, randomized phase 3 study evaluating telotristat etiprate (TE), a tryptophan hydroxylase inhibitor, among patients (pts) with carcinoid syndrome (CS). When added to somatostatin analogues (SSA), 250 mg tid and 500 mg tid TE each produced significantly greater bowel movement (BM) frequency reduction averaged over 12 weeks (wks) than placebo (PBO) plus SSA (p<0.001). Pts crossed over to open-label (OL) treatment with TE 500 mg tid after Wk 12. The extension phase (Wk 13 to Wk 48) is still ongoing

Conference: 13th Annual ENETSConcerence (2016)

Presenting Author: Hörsch D

Authors: Hörsch D, Kulke M, Caplin M, Anthony L, Bergsland E,

Keywords: telotristat, carcinoid syndrome, tryptophan,

#1272 Telotristat Etiprate Appears to Halt Carcinoid Heart Disease

Introduction: Carcinoid Heart Disease (CHD) is a serious complication of the Carcinoid Syndrome (in as many as 50% of patients during the course of their disease). 46% of cases operated with bioprosthetic valves develop recurrent carcinoid valvulopathy on the newly implanted tissue valves. Until now, only mechanical prosthetic valves avoid recurrent fibrosis.

Conference: 13th Annual ENETSConcerence (2016)

Presenting Author: Zacks J

Authors: Zacks J, Lavine R, Ratner L, Warner R,

Keywords: carcinoid heart disease, valve, heart failure, carcinoid syndrome, prosthetic valves, telotristat etiprate,

#1068 Telotristat Etiprate in a Subset of Carcinoid Syndrome Patients Who Have High Levels of Urinary 5-hydroxyindoleacetic Acid and Frequent Flushing

Introduction: Serotonin is a key mediator of carcinoid syndrome (CS). CS patients (pts) with high levels of urinary 5-hydroxyindoleacetic acid (u5-HIAA, a serotonin metabolite) and >3 flushing episodes/day are at increased risk of developing carcinoid heart disease (CaHD).

Conference: 12th Annual ENETSConcerence (2015)

Presenting Author: Wheeler D

Authors: Wheeler D, Hörsch D, Valle J, Lapuerta P, Zambrowicz B,

Keywords: biomarker, carcinoid heart disease,

#870 Telotristat Etiprate (TE) in a Cohort of Carcinoid Heart Disease Patients in Two Phase 2 Trials

Introduction: Serotonin is a key mediator of carcinoid syndrome (CS). High levels of urinary 5-hydroxyindoleacetic acid (u5-HIAA, a serotonin metabolite) have also been linked with carcinoid heart disease (CaHD). Telotristat etiprate (TE), a novel, oral inhibitor of serotonin synthesis, is in Phase 3 development for the treatment of CS.

Conference: 11th Annual ENETSConcerence (2014)

Presenting Author:

Authors: Wheeler D, Kulke M, O’Dorisio T, Hörsch D, Jackson S,

Keywords: carcinoid, heart disease, serotonin, telotristat,