ECEESPE2025 Rapid Communications Rapid Communications 4: Pituitary, Neuroendocrinology and Puberty Part 1 (6 abstracts)
Results from the core phase of the open-label, phase 3 ACROINNOVA 2 trial: CAM2029, a subcutaneous octreotide depot, achieves sustained, long-term biochemical control in acromegaly
Joanna L. Spencer-Segal 1 , Julie M. Silverstein 2 , Aleksandra Gilis-Januszewska 3 , Guzin Fidan Yaylali 4 , Elena Isaeva 5 , Monica R. Gadelha 6 , Beverly M.K. Biller 7 , Pietro Maffei 8 , Maria Fleseriu 9 , Alberto M. Pedroncelli 10 , Jacob Råstam 10 , Maria Harrie 10 , Agneta Svedberg 10 , Fredrik Tiberg 10 & Diego Ferone 11
1Department of Internal Medicine and Michigan Neuroscience Institute, University of Michigan, Ann Arbor, MI, United States; 2Division of Endocrinology, Metabolism and Lipid Research, Department of Neurosurgery, Washington University School of Medicine, St. Louis, MO, United States; 3Department of Endocrinology, Jagiellonian University Medical College, Kraków, Poland; 4Department of Endocrinology and Metabolic Diseases, Faculty of Medicine, Pamukkale University Faculty of Medicine, Denizli, Türkiye; 5Interregional Clinical Diagnostic Center, Kazan, Russian Federation; 6Neuroendocrinology Research Center/Endocrinology Division, Medical School and Hospital Universitario Clementino Fraga Filho, Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil; 7Neuroendocrine and Pituitary Tumor Clinical Center, Massachusetts General Hospital, Boston, MA, United States; 8Department of Medicine, Padua University Hospital, Padua, Italy; 9Pituitary Center, Departments of Medicine and Neurological Surgery, Oregon Health and Science University, Portland, OR, United States; 10Camurus AB, Lund, Sweden; 11Endocrinology Unit, Department of Internal Medicine, IRCCS Ospedale Policlinico San Martino, Genova, Italy
JOINT1743
Background: Effective biochemical control of excess insulin-like growth factor-I (IGF-I) and growth hormone (GH) is essential to alleviate symptoms and associated conditions of acromegaly. CAM2029, an octreotide subcutaneous depot designed with FluidCrystal® technology to be long-acting, is conveniently self-administered using an autoinjector pen. In ACROINNOVA 1, a 24-week, Phase 3 trial (NCT04076462), CAM2029 demonstrated superior biochemical control versus placebo (72.2% vs 37.5%; P=0.0018) in patients previously controlled (IGF-I ≤ upper limit of normal [ULN]) on standard-of-care somatostatin receptor ligands (SoC; octreotide long-acting repeatable/lanreotide Autogel). ACROINNOVA 2 (NCT04125836), a 52-week, open-label, Phase 3 trial (plus 52-week extension), assessed long-term safety and efficacy.
Methods: ACROINNOVA 2 included patients from ACROINNOVA 1 (prior-placebo and prior CAM2029 groups) and directly-enrolled patients with IGF-I ≤2×ULN (on SoC for ≥3 months). Patients received CAM2029 20 mg every 4 weeks (±1 week) for 52 weeks (prior-placebo: week [W] 24–52). The primary endpoint characterised safety; secondary endpoints included the proportion of patients with IGF-I ≤ULN (W50/52 mean) and both IGF-I ≤ULN (W50/52 mean) and GH <2.5 µg/l (W52 mean).
Results: In total, 135 patients were enrolled: 54 completing ACROINNOVA 1 (prior-placebo, n=18; prior-CAM2029, n=36) and 81 directly-enrolled. Overall, 127 patients (94.1%) completed treatment (prior-placebo, n=18; prior-CAM2029, n=35; directly-enrolled, n=74). CAM2029 was well tolerated; no new safety signals were identified. The most common adverse events (AEs) were injection-site erythema and injection-site swelling, occurring in 27.4% (37/135) and 14.8% (20/135) of patients, respectively. All injection-site AEs were mild-to-moderate (Grade 1–2); new injection-site AEs decreased throughout the study. AEs leading to treatment discontinuation occurred in 1.5% (2/135) of patients. The proportion of patients with biochemical control are presented in the Table.
| Prior-placebo | Prior-CAM2029 | Directly-enrolled | ||
| Endpoint(s) | Timepoint | n/Nall* (%) | ||
| SoC baseline | 17/18 (94.4) | 33/36 (91.7) | 12/81 (14.8) | |
| IGF-I ≤ULN | Placebo baseline† | 5/18 (27.8) | – | – |
| W50/52 mean | 17/18 (94.4) | 31/35 (88.6) | 27/74 (36.5) | |
| SoC baseline | 17/18 (94.4) | 33/36 (91.7) | 12/81 (14.8) | |
| IGF-I ≤ULN and GH <2.5 µg/l | Placebo baseline† | 5/18 (27.8) | – | – |
| IGF-I: W50/52 mean | ||||
| GH: W52 mean | 16/17 (94.1) | 29/33 (87.9) | 23/74 (31.1) | |
| *Patients with available data at timepoint; †IGF-I: W22/24, GH: W24. | ||||
Conclusions: CAM2029 treatment resulted in biochemical control being regained in prior-placebo and sustained in prior-CAM2029 patients. Biochemical control was notably improved in directly-enrolled patients previously uncontrolled on SoC. These long-term findings support CAM2029 as an effective new treatment for acromegaly with a safety profile consistent with SoC.
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