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Labadzhyan A, Nachtigall LB, Fleseriu M, et al. Oral octreotide capsules for the treatment of acromegaly: comparison of 2 phase 3 trial results. Pituitary. 2021;24(6):943-953doi: 10.1007/s11102-021-01163-2.
Labadzhyan, A., Nachtigall, L. B., Fleseriu, M., Gordon, M. B., Molitch, M., Kennedy, L., Samson, S. L., Greenman, Y., Biermasz, N., Bolanowski, M., Haviv, A., Ludlam, W., Patou, G., & Strasburger, C. J. (2021). Oral octreotide capsules for the treatment of acromegaly: comparison of 2 phase 3 trial results. Pituitary, 24(6), 943-953. https://doi.org/10.1007/s11102-021-01163-2
Labadzhyan, Artak, et al. "Oral octreotide capsules for the treatment of acromegaly: comparison of 2 phase 3 trial results." Pituitary vol. 24,6 (2021): 943-953. doi: https://doi.org/10.1007/s11102-021-01163-2
Labadzhyan A, Nachtigall LB, Fleseriu M, Gordon MB, Molitch M, Kennedy L, Samson SL, Greenman Y, Biermasz N, Bolanowski M, Haviv A, Ludlam W, Patou G, Strasburger CJ. Oral octreotide capsules for the treatment of acromegaly: comparison of 2 phase 3 trial results. Pituitary. 2021 Dec;24(6):943-953. doi: 10.1007/s11102-021-01163-2. Epub 2021 Jun 25. PMID: 34173129; PMCID: PMC8550586.
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Pituitary. 2021 Dec;24(6):943-953. doi: 10.1007/s11102-021-01163-2. Epub 2021 Jun 25.

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

Pituitary

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

Affiliations

  1. Cedars-Sinai Medical Center, Los Angeles, CA, 90048, USA. [email protected].
  2. MGH Neuroendocrine and Pituitary Center, Chestnut Hill, MA, USA.
  3. Pituitary Center, Oregon Health & Sciences University, Portland, OR, USA.
  4. Allegheny Neuroendocrinology Center, Allegheny General Hospital, Pittsburgh, PA, USA.
  5. Northwestern University, Chicago, IL, USA.
  6. Cleveland Clinic Foundation, Cleveland, OH, USA.
  7. Mayo Clinic, Jacksonville, FL, USA.
  8. Sourasky Medical Center and Tel Aviv University, Tel Aviv, Israel.
  9. Leiden University Medical Center, Leiden, The Netherlands.
  10. Wroclaw Medical University, Wroclaw, Poland.
  11. Chiasma, Inc., Needham, MA, USA.
  12. Cedars-Sinai Medical Center, Los Angeles, CA, 90048, USA.
  13. Charite Universitatsmedizin, Berlin, Germany.

PMID: 34173129 PMCID: PMC8550586 DOI: 10.1007/s11102-021-01163-2

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).

© 2021. The Author(s).

Keywords: Acromegaly; Growth hormone; IGF-I; Oral octreotide; Somatostatin analogs; Somatostatin receptor ligands

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