Oral octreotide capsules for the treatment of acromegaly: comparison of 2 phase 3 trial results

Artak Labadzhyan*, L. B. Nachtigall, M. Fleseriu, M. B. Gordon, M. Molitch, L. Kennedy, S. L. Samson, Y. Greenman, N. Biermasz, M. Bolanowski, A. Haviv, W. Ludlam, G. Patou, C. J. Strasburger

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

Abstract

Purpose: Results are presented from 2 to 3 trials investigating oral octreotide capsules (OOC) as an alternative to injectable somatostatin receptor ligands (iSRLs) in the treatment of acromegaly. Methods: CH-ACM-01 was an open-label trial (N = 155) and CHIASMA OPTIMAL was a double-blind placebo-controlled (DPC) trial (N = 56), both investigating OOC as maintenance therapy for patients with acromegaly who were biochemical responders receiving iSRLs. Results: Baseline characteristics in both trials reflected those expected of patients with acromegaly responding to treatment and were similar between trials, despite differences in inclusion criteria. OOC demonstrated a consistent degree of biochemical response across trials, with 65% of patients in CH-ACM-01 maintaining response during the core period and 64% of patients in CHIASMA OPTIMAL at the end of the DPC. Mean insulin-like growth factor I (IGF-I) levels remained within inclusion criteria at the end of treatment in both trials. Of 110 patients entering the fixed-dose phase in CH-ACM-01, 80% maintained or improved acromegaly symptoms from baseline to the end of treatment. Over 85% of patients in both trials elected to continue into the extension phases. OOC were found to be well tolerated across both trials, and no dose-related adverse events were observed. Conclusions: OOC demonstrated remarkably consistent results for biochemical response, durability of response, and preference to continue with oral treatment across these 2 complementary landmark phase 3 trials, despite differences in the design of each. Trial registration NCT03252353 (August 2017), NCT01412424 (August 2011).

Original languageEnglish (US)
JournalPituitary
DOIs
StateAccepted/In press - 2021

Keywords

  • Acromegaly
  • Growth hormone
  • IGF-I
  • Oral octreotide
  • Somatostatin analogs
  • Somatostatin receptor ligands

ASJC Scopus subject areas

  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

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