SFEBES2022 Oral Communications Reproductive and Neuroendocrinology (6 abstracts)
Long-term efficacy and safety of oral, once-daily paltusotine treatment in acromegaly: Two-year interim results from the ACROBAT Advance study
Harpal Randeva 1,2 , Monica Gadelha 3,4 , Murray Gordon 5 , Mirjana Doknic 6 , Emese Mezősi 7 , Miklós Tóth 8 , Cesar Boguszewski 9 , Christine Ferrara-Cook 10 , Alessandra Casagrande 10 & Alan Krasner 10
1University Hospitals Coventry, Coventry, United Kingdom; 2Warwickshire NHS Trust, Coventry, United Kingdom; 3Neuroendocrinology Research Center/Endocrinology Division--Medical School and Hospital Universitario Clementino Fraga Filho, Rio de Janeiro, Brazil; 4Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil; 5Allegheny Neuroendocrinology Center, Allegheny General Hospital, Pittsburgh, United state of America; 6Neuroendocrine Department, Clinic for Endocrinology, Diabetes and Metabolic Diseases, University Clinical Center of Serbia, Belgrade, Serbia; 7University of Pécs Medical School, Pécs, Hungary; 8Semmelweis University, Budapest, Hungary; 9SEMPR, Endocrine Division, Department of Internal Medicine, Federal University of Parana, Curitiba, Brazil; 10Crinetics Pharmaceuticals Inc., San Diego, United state of America
Paltusotine is an investigational oral, once-daily, non-peptide, SST2 agonist in development for the treatment of acromegaly and neuroendocrine tumors. Interim analysis results from subjects with acromegaly treated with paltusotine for up to 2 years in ACROBAT Advance (NCT04261712), an ongoing, open-label extension study are reported here. Prior to Advance, subjects previously completed one of two Phase 2 parent studies, Evolve (NCT03792555, with normal IGF-1 using injected long-acting octreotide or lanreotide monotherapy [iSRL]) or Edge (NCT0378965), which enrolled acromegaly subjects, all of whom required second line therapy beyond iSRL monotherapy in order to achieve IGF-1 normalization. Forty-three subjects enrolled in Advance. Mean (SD) age, 53 (11.61) years; 56% female; 86% had previous pituitary surgery. Median (IQR) IGF-1 was stably maintained on iSRL: baseline 1.15xULN (0.84, 1.46, n=43); Week 51 1.08xULN (0.87, 1.26, n=37); Week 77 1.00xULN (0.85, 1.27, n=27); Week 103 1.10xULN (0.96, 1.45, n=10). IGF-1 remained unchanged both in subjects with normal and elevated baseline IGF-1. Cabergoline (and pegvisomant if needed) was allowed for subjects with inadequately controlled IGF-1 at the maximum tolerated dose of paltusotine. Most (94%) of those receiving adjunctive medication in Advance were either sub-optimally controlled or required combination therapy or pasireotide in order to achieve normal IGF-1 at the parent study iSRL baseline. The most common treatment-emergent adverse events (TEAEs) reported were headache (30.2%), arthralgia (25.6%) and fatigue (18.6%). No serious drug-related TEAEs were reported. Of the 6 subjects who discontinued the study, only 1 (2.3%) was due to a TEAE (headache). With up to 2 years of follow-up, once-daily oral paltusotine is associated with stable IGF-1 control relative to that achieved by iSRLs and continues to be well tolerated.
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Endocrine Abstracts
ISSN 1470-3947 (print) | ISSN 1479-6848 (online)
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