Oral octreotide efficacy maintained in more than 90% of adults with acromegaly at 3 years
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ATLANTA — More than 90% of adults with acromegaly remained responders to oral octreotide 3 years after initiating treatment, according to findings from the MPOWERED open-label extension study presented at ENDO 2022.
“Oral octreotide capsules, the first oral somatostatin receptor ligands approved for patients with acromegaly previously controlled on injectable somatostatin receptor ligands, have durable safety and efficacy and may represent a favorable option for acromegaly maintenance therapy in many patients,” Maria Fleseriu, MD, FACE, professor of medicine and neurological surgery and director of the Pituitary Center at Oregon Health & Science University in Portland, and co-editor for Healio | Endocrine Today, told Healio. “Patients in the open-label extension have completed as many as 3 full years of oral octreotide capsule use to date, thus showing consistency and durability in this population.”
As Healio previously reported, more than 90% of participants with acromegaly in the MPOWERED phase 3 trial were responders to oral octreotide (Mycapssa, Chiasma) at 36 weeks. There were 60 participants who continued to use oral octreotide in an open-label extension, with 51 completing year 1 of the extension study, 41 completing year 2 and 14 completing year 3. Participants were defined as responders if they had an insulin-like growth factor I less than 1.3 times the upper limit of normal. Safety outcomes were collected at the end of each year.
Most participants maintained a biochemical response to oral octreotide in the open-label extension, with 94% maintaining a response at 1 year, 90% at 2 years and 93% at year 3. Mean IGF-I levels remained below the upper limit of normal in the study cohort during the open-label extension.
There were 19 adults who originally used injectable somatostatin receptor ligands during the phase 3 trial and later switched to oral octreotide participating in the open-label extension. Within the subgroup, there was a 67% increase in the percentage of adults who described their symptom control as either excellent or very good. Treatment convenience and treatment satisfaction also significantly improved in those who began with injectable somatostatin receptor ligands and switched to oral octreotide.
“On average, those 19 patients actually showed improved outcomes in terms of their acromegaly symptom control as well as how they regarded their oral octreotide treatment’s convenience and their overall satisfaction with the oral octreotide,” Fleseriu said. “So not only was the oral octreotide safe and effective from prespecified endpoints measurements, but these patients also expressed improved satisfaction with their care in the setting of oral treatment.”
The safety profile of octreotide during the open-label extension was consistent with what was observed in the phase 3 trial. No new adverse event patterns were observed during the open-label extension.
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Fleseriu M, et al. PMON159. Presented at: ENDO Annual Meeting; June 11-14, 2022; Atlanta (hybrid meeting).
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