ECEESPE2025 Poster Presentations Pituitary, Neuroendocrinology and Puberty (162 abstracts)
CAM2029, a self-administered subcutaneous octreotide depot, improved pros and symptoms in patients with ACROMEGALY in the acroinnova 2 phase 3 trial: final analysis of the core phase results
Diego Ferone 1 , Beverly M.K. Biller 2 , Monica R. Gadelha 3 , Julie M. Silverstein 4 , Pinar Kadioglu 5 , Jochen Seufert 6 , Maria Fleseriu 7 , Alberto M. Pedroncelli 8 , Jacob Råstam 8 , Maria Harrie 8 , Agneta Svedberg 8 , Fredrik Tiberg 8 & Joanna L. Spencer-Segal 9
1Endocrinology Unit, Department of Internal Medicine, IRCCS Ospedale Policlinico San Martino, Genova, Italy; 2Neuroendocrine and Pituitary Tumor Clinical Center, Massachusetts General Hospital, Boston, MA, United States; 3Neuroendocrinology Research Center/Endocrinology Division, Medical School and Hospital Universitario Clementino Fraga Filho, Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil; 4Division of Endocrinology, Metabolism and Lipid Research, Department of Neurosurgery, Washington University School of Medicine, St. Louis, MO, United States; 5Division of Endocrinology-Metabolism and Diabetes, Department of Internal Medicine, Istanbul University-Cerrahpaşa, Istanbul, Türkiye; 6Division of Endocrinology and Diabetology, Department of Medicine II, Medical Center, University of Freiburg, Freiburg, Germany; 7Pituitary Center, Departments of Medicine and Neurological Surgery, Oregon Health and Science University, Portland, OR, United States; 8Camurus AB, Lund, Sweden; 9Department of Internal Medicine and Michigan Neuroscience Institute, University of Michigan, Ann Arbor, MI, United States
JOINT2769
Background: Patients with acromegaly have an unmet need for therapies with a lower treatment burden that do not require healthcare-professional administration. CAm2029 utilises FluidCrystal® technology and provides a long-acting octreotide subcutaneous depot, self-administered via an autoinjector pen. ACROINNOVA 1 (NCT04076462) was a Phase 3, 24-week, randomised, double-blind trial of CAm2029 in patients who are biochemically controlled (insulin-like growth factor-I [IGF-I] ≤ upper limit of normal [ULN] on standard-of-care [SoC] somatostatin receptor ligands at baseline [octreotide long-acting repeatable/lanreotide Autogel]). The primary endpoint was met, demonstrating superior biochemical control with CAm2029 vs placebo. Long-term safety, efficacy and patient-reported outcomes (PROs) with CAm2029 were further evaluated in ACROINNOVA 2 (NCT04125836), a 52-week, open-label Phase 3 trial.
Methods: Patients enrolled into ACROINNOVA 2 directly or after completing ACROINNOVA 1. Directly enrolled patients had IGF-I ≤2×ULN on SoC. Patients received CAm2029 20 mg every 4 weeks (±1 week) for 52 weeks (ACROINNOVA 1 prior-placebo: 28 weeks). The primary endpoint characterised safety. PROs included Acromegaly Quality of Life Questionnaire (AcroQoL), Treatment Satisfaction Questionnaire for Medication (TSQM) and severity of signs and symptoms over time (assessed using Acromegaly Index of Severity [AIS]). Data are shown for the overall population for the core 52 weeks.
Results: Of 135 patients enrolled (directly enrolled, n = 81; prior-placebo; n = 18, prior-CAm2029, n = 36), 127 completed treatment. PROs and symptom burden continuously improved from baseline to week 52; results also indicated improvement from week 24 to 52 (Table). CAm2029 was well tolerated, with no new safety signals identified.
| AcroQoL and TSQM (Higher scores indicate improvement) | |||||
| Change from baseline | |||||
| Week 24 | Week 52 | ||||
| n | Mean (95% CI) | n | Mean (95% CI) | ||
| AcroQoL(range 0–100) | |||||
| Total score | 128 | 1.8 (-0.1, 3.8) | 123 | 3.0 (1.0, 5.0) | |
| TSQM domain scores (range 0–100) | |||||
| Convenience | 115 | 12.0 (8.6, 15.4) | 112 | 15.4 (12.0, 18.8) | |
| Effectiveness | 116 | 0.9 (-3.2, 5.0) | 113 | 5.4 (2.1, 8.8) | |
| Global satisfaction | 116 | 0.5 (-3.2, 4.2) | 113 | 4.0 (0.8, 7.2) | |
| AIS(Lower scores indicate improvement) | |||||
| n | Baseline, Mean (standard deviation) | n | Change from baseline to week 52, Mean (95% CI) | ||
| AIS Overall score (range 0–18) | 135 | 4.3 (3.4) | 124 | -1.2 (-1.7, -0.6) | |
| CI, confidence interval. | |||||
Conclusions: Long-term treatment with CAm2029 reduced the symptom burden of patients over 52 weeks, providing continuous improvements in QoL and treatment satisfaction scores vs SoC baseline. ACROINNOVA 2 demonstrates the combined patient benefits of convenient administration, improved QoL, treatment satisfaction and symptom control provided by CAm2029.
Volume 110
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Endocrine Abstracts
ISSN 1470-3947 (print) | ISSN 1479-6848 (online)
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