@article{e25e489c77784bec91cb1968f95f475b,
title = "Oral octreotide capsules for the treatment of acromegaly: comparison of 2 phase 3 trial results",
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).",
keywords = "Acromegaly, Growth hormone, IGF-I, Oral octreotide, Somatostatin analogs, Somatostatin receptor ligands",
author = "Artak Labadzhyan and Nachtigall, {L. B.} and M. Fleseriu and Gordon, {M. B.} and M. Molitch and L. Kennedy and Samson, {S. L.} and Y. Greenman and N. Biermasz and M. Bolanowski and A. Haviv and W. Ludlam and G. Patou and Strasburger, {C. J.}",
note = "Funding Information: AL reports no conflicts of interest. LBN served as research support for Chiasma and received grant support from and served as a consultant for Ipsen. MF received a research grant to Oregon Health and Science University as principal investigator for Crinetics, Chiasma, Ionis, Novartis, Recordati and served as a scientific consultant for Crinetics, Chiasma, Ionis, Ipsen, Novartis, Pfizer, and Recordati. MBG received research support from Chiasma, Corcept, Crinetics, Ipsen, Novartis, Opico, Pfizer, Strongbridge, Teva, and Novo Nordisk and served as a scientific consultant for Chiasma and Novo Nordisk. MM received research grant to institution from Chiasma, Novartis, and Crinetics and received a consultation honorarium from Chiasma. LK served as a clinical trial principal investigator for Chiasma and Ionis and served as a consultant for Pfizer. SLS served as site principal investigator, steering chair, and consultant for Chiasma and Novartis. YG received funding in the form of a research grant from Pfizer and was compensated for serving as principal investigator of research grants to Tel Aviv-Sourasky Medical Center from Chiasma and Strongbridge Biopharma, and also received consultation fees from Tiburio and lecture fees from CTS. NB reports no conflicts of interest. MB received a research grant from Ispen and lecture fees from Ispen, Novartis, Pfizer, and Recordati, and also served as an advisory board member for Novartis, Pfizer, and Recordati. AH, WHL, GP are employees of Chiasma. CJS received consultancy fees and speaker honoraria from Chiasma, Pfizer, Ipsen, and Crinetics. Funding Information: The authors thank the trial coordinators, coinvestigators, patients, and families who participated in the trials. Medical writing assistance and revision of the manuscript under the direction of the authors was provided by PRECISIONscientia, which was supported by Chiasma, Inc. Publisher Copyright: {\textcopyright} 2021, The Author(s).",
year = "2021",
month = dec,
doi = "10.1007/s11102-021-01163-2",
language = "English (US)",
volume = "24",
pages = "943--953",
journal = "Pituitary",
issn = "1386-341X",
publisher = "Kluwer Academic Publishers",
number = "6",
}
