The Lancet Diabetes & Endocrinology publishes positive results for the MPOWERED phase III trial for Mycapssa in acromegaly patients.- Amryt
The MPOWERED trial was designed to support the marketing authorization application for Mycapssa to the EMA which is currently under evaluation. The MPOWERED trial adds to the evidence base built with two previous Phase III trials, CH-ACM-01 and CHIASMA OPTIMAL, both of which supported the FDA approval of Mycapssa for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with injectable octreotide or lanreotide.
Key outcomes of the MPOWERED Phase III Trial are listed below : i. Mycapssa was non-inferior to long-acting injectable octreotide or lanreotide in maintenance of biochemical control, in patients previously responding to both treatments. ii. On the primary endpoint of the proportion of patients maintaining biochemical response throughout the 9-month Randomized Control Treatment (RCT) phase, 91% of patients on Mycapssa maintained response compared to 100% on iSRLs. Response was defined as the time-weighted average of IGF-1 <1.3 x upper limit of normal (uln) throughout the phase. mean igf-1 was the same at the start and end of the rct phase in both groups and was maintained within normal limits. iii.all sensitivity analyses supported the results of the primary endpoint using both time-weighted average and more traditional landmark methods of analyzing igf-1 data.></1.3>
Oral octreotide results for breakthrough and active acromegaly symptoms :i. At the end of the RCT phase, 15% of patients in the oral octreotide group reported breakthrough symptoms of acromegaly, compared with 31% in the iSRL group. The overall number of individual active acromegaly symptoms was similar between treatment groups. ii.A significant reduction in the number of certain active acromegaly symptoms was reported in patients responding to Mycapssa at the end of the run-in phase. Specifically, significant reductions were shown in the proportions of participants with swelling of extremities (p=0.01) and fatigue (p=0.03).
Patient reported outcomes with oral octreotide capsules.: i. A significant improvement was reported from baseline while treated with iSRLs to the end of the run-in phase in patients responding to Mycapssa in three of the five Acromegaly Treatment Satisfaction Questionnaire (Acro-TSQ) scales (emotional reaction, treatment convenience, and treatment satisfaction), with improving trends in the other two scales (gastrointestinal interference and symptom interference). ii. Change from start of the RCT phase for each of the five Acro-TSQ scales was generally similar between treatment groups.
Oral octreotide capsules showed comparable safety profile to iSRLs : The incidence of adverse events (AEs) during the RCT was similar between groups with 39 (71%) of 55 participants in the oral octreotide group and 26 (70%) of 37 participants in the iSRL group reporting at least one AE. In both treatment groups, most treatment-related AEs were gastrointestinal. 17 (47%) of 36 participants randomly assigned to iSRL reported injection site reactions via the Acro-TSQ scales at the end of the RCT, and 13 (81%) of 16 reported that injection site reactions interfered with daily activities.
See- "Maintenance of response to oral octreotide compared with injectable somatostatin receptor ligands in patients with acromegaly: a phase III, multicentre, randomised controlled trial."-Prof Maria Fleseriu, MD Alexander Dreval, MD ,Prof Irina Bondar, DMSc, et al. Published:December 22, 2021DOI:https://doi.org/10.1016/S2213-8587(21)00296-5.
Related news and insights
Amryt presented positive clinical data from the open-label extensions (OLEs) of two of the Phase III trials of Mycapssa (oral octreotide), OPTIMAL and MPOWERED , at the Endocrine Society’s annual meeting, ENDO 2022.
Amryt presents long-term safety and efficacy data from the 2nd year open-label extension (OLE) of its global Phase III OPTIMAL clinical trial that compared Mycapssa (octreotide capsules) to placebo for maintenance of biochemical response in patients with acromegaly.
Amryt presents long-term safety and efficacy data from the open-label extension (OLE) of its global Phase III MPOWERED non-inferiority clinical trial that compared Mycapssa (oral octreotide capsules) to long-acting iSRLs (injectable Somatostatin Receptor Ligands) for maintenance of biochemical response in patients with acromegaly.