SFEBES2026 Oral Communications Neuroendocrinology and Pituitary (6 abstracts)
1Department of Endocrinology, St James’s University Hospital, Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom; 2Warwick Medical School, University of Warwick, Coventry, United Kingdom; 3WISDEM, University Hospitals Coventry and Warwickshire NHS Trust, Coventry, United Kingdom; 4Department of Endocrinology, Manchester Centre for Clinical Neurosciences, Salford Royal Foundation Trust, Manchester, United Kingdom; 5Pituitary Center, Departments of Medicine and Neurological Surgery, Oregon Health and Science University, Portland, OR, USA; 6Neuroendocrine and Pituitary Tumor Clinical Center, Massachusetts General Hospital, Boston, MA, USA; 7Neuroendocrinology Research Center/Endocrinology Division, Medical School and Hospital Universitario Clementino Fraga Filho, Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil; 8Camurus AB, Lund, Sweden; 9Endocrinology Unit, Department of Internal Medicine, IRCCS Ospedale Policlinico San Martino, Genova, Italy
Biochemical control is crucial to reduce morbidity and improve quality of life (QoL) for patients with acromegaly. CAM2029, a long-acting, octreotide subcutaneous depot, is conveniently self-administered via an autoinjector pen with small-gauge needle. In the 24-week (W), Phase 3 ACROINNOVA 1 trial (NCT04076462), CAM2029 achieved superior biochemical control versus placebo and improved QoL from standard of care (SoC) in patients previously biochemically controlled. ACROINNOVA 2 (NCT04125836) assessed long-term (52W) safety and efficacy. ACROINNOVA 2, a Phase 3, open-label trial (with 52W extension), directly enrolled (DE) patients with insulin-like growth factor I (IGF-I) ≤2×upper limit of normal (ULN; per age and sex) on SoC, and patients completing ACROINNOVA 1 (prior-CAM2029; prior-placebo). Patients received CAM2029 20 mg every 4W (±1W) for 52W (prior-placebo, W24–52). The primary objective was to evaluate safety. Secondary endpoints included the proportion of patients with biochemical control (IGF-I ≤ULN; W50/52 mean), Acromegaly Index of Severity scores (symptom severity) and patient-reported outcomes (PROs) including the Acromegaly QoL Questionnaire and treatment satisfaction. 135 patients were enrolled: 81 DE, 36 prior-CAM2029, 18 prior-placebo; 127 patients completed treatment. CAM2029 was well tolerated with no new safety signals. IGF-I control among DE patients improved from 14.8% at baseline to 36.5% at W50/52. At W50/52, IGF-I control was sustained in 88.6% of prior-CAM2029 patients; prior-placebo patients regained IGF-I control with CAM2029 (94.4% had IGF-I control at W50/52). In the overall population, symptoms and multiple PROs, including QoL and treatment satisfaction, were progressively improved from baseline to W52; results indicated some further improvements from W24 to W52. CAM2029 had a long-term safety profile comparable to SoC and offered sustained biochemical and symptom control of acromegaly, with improvements in QoL and treatment satisfaction versus SoC baseline. These results support CAM2029 as a promising treatment option for acromegaly with tangible improvements in PROs.