ECE2021 Presented Eposters Presented ePosters 3: Pituitary and Neuroendocrinology (8 abstracts)
Safety results from MPOWERED, a phase 3 trial of oral octreotide capsules in adults with acromegaly
Pamela U. Freda 1 , Maria Fleseriu 2 , Alexander V. Dreval 3 , Yulia Pokramovich 3 , Irina Bondar 4 , Elena Isaeva 5 , Wenyu Huang 6 , Mark E. Molitch 6 , Djuro P. Macut 7 , Nina Leonova 8 , Gerald Raverot 9 , Yossi Gilgun-Sherki 10 , William H. Ludlam 11 , Gary Patou 12 , Asi Haviv 13 , Murray B. Gordon 14 , Nienke Biermasz 15 , Shlomo K. Melmed 16 & Christian J. Strasburger 17
1Columbia University, USA; 2Oregon Health and Science University, USA; 3M.F. Vladimirsky Moscow Regional Research Clinical Institute, Russian Federation; 4Novosibirsk State Medical University, Russian Federation; 5Interregional Clinical Diagnostic Center, Russian Federation; 6Northwestern University Feinberg School of Medicine, USA; 7University of Belgrade, Serbia; 8Antrium Multidisciplinary Medical Clinic, Russian Federation; 9Hospices Civils de Lyon, France; 10Chiasma, Inc, Israel; 11Chiasma, Inc., USA; 12Chiasma, Inc, USA; 10Chiasma, Inc, Israel; 14Allegheny General Hospital, USA; 15Leiden University Medical Center, Netherlands; 16Cedars Sinai Medical Center, USA; 17Charite Campus Mitte, Germany
Background
Injectable somatostatin receptor ligands (iSRLs) have been a mainstay in acromegaly treatment. Oral octreotide capsules (OOC; MYCAPSSA®) were recently approved in the USA. Results from the placebo-controlled CHIASMA OPTIMAL and open-label CH-ACM-01 studies showed an OOC safety profile consistent with that of iSRLs with no new or unexpected safety signals. Results of the MPOWERED trial have enabled a comparison of OOC safety and efficacy with iSRLs.
Methods
To enter MPOWERED, patients must have the following: acromegaly diagnosis, biochemical control of acromegaly (insulin-like growth factor I <1.3 × upper limit of normal; mean integrated growth hormone <2.5 ng/ml), and ≥6 months’ iSRLs treatment (octreotide or lanreotide). Eligible patients entered a 26-week Run-in phase to determine the effective OOC dose; responders at week 24 then entered a 36-week randomized controlled treatment (RCT) phase receiving OOC or iSRLs. Safety was monitored as adverse events (AEs) in both arms throughout the trial, including the RCT.
Results
In the RCT, incidence of treatment-emergent adverse events (TEAEs) was similar between groups; 39 patients (70.9%) in the OOC group and 26 (70.3%) in the iSRL group had ≥1 TEAE. 19 patients (34.5%) in the OOC and 15 (40.5%) in the iSRL group had treatment-related TEAEs. Occurrence was similar for serious AEs (OOC, 5.5%; iSRL, 8.1%) as well as TEAEs classified as severe (OOC, 9.1%; iSRL, 10.8%). One patient in the OOC group discontinued due to a TEAE. The most common gastrointestinal TEAEs were flatulence (OOC, 25.5%; iSRL, 21.6%), nausea (OOC, 20.0%; iSRL, 8.1%), diarrhea (OOC, 10.9%; iSRL, 13.5%), abdominal pain (OOC, 9.1%; iSRL, 8.1%), and constipation (OOC, 5.5%; iSRL, 13.5%). AEs of interest were infrequent, including cholelithiasis (OOC, n = 0; iSRL, n = 1 [2.7%]) and secondary hypothyroidism (OOC, n = 1 [1.8%]; iSRL, n = 0). In the iSRL group, 32.4% of patients reported injection site reactions (ISRs) during the RCT, and 47% of patients reported ISRs as part of the Acromegaly Treatment Satisfaction Questionnaire, a newly validated patient-reported outcome tool.1
Conclusion
Safety results from MPOWERED align with prior trials, showing that the OOC safety profile is consistent with that of iSRLs as well as the acromegaly disease burden. No new or unexpected safety signals were identified during the trial. Safety results were mostly similar between OOC and iSRLs, although patients in the OOC group did not experience any ISRs.
1Fleseriu M, et al. Pituitary. 2020 Aug;23(4):347–358.
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Endocrine Abstracts
ISSN 1470-3947 (print) | ISSN 1479-6848 (online)
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