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Neuroendocrinology and Pituitary

MON-036 - Long-Term Safety and Efficacy of CAM2029 in Patients with Acromegaly: Results from the ACROINNOVA 2 Open-Label Extension

Monday, June 15, 2026
9:00 AM - 2:00 PM CT
Location: ENDOExpo; Poster Floor
Background
Long-term biochemical control of acromegaly is essential to manage symptoms and reduce mortality risk. CAM2029 is a long-acting, octreotide subcutaneous depot, recently approved in Europe and the UK. The Phase 3 ACROINNOVA 2 study demonstrated long-term safety and efficacy of CAM2029, including patients not biochemically controlled on standard of care (SoC). We report the 1-year ACROINNOVA 2 extension results.

Methods
ACROINNOVA 2 was an open-label, 52-week (W) trial (core phase) with a 52W extension. Patients who completed CAM2029 treatment at W48 and the W52 assessment in the core phase could continue CAM2029 (direct continuation [DC]) in the extension phase. Patients could restart CAM2029 after completing the core phase and either after return to SoC or after >4 weeks elapsed. CAM2029 20 mg was administered every 4W±1W via pre-filled pen. The primary endpoint was safety. Secondary endpoints included biochemical control rate (insulin-like growth factor I [IGF-I] ≤upper limit of normal per age and sex [ULN]), symptom control (Acromegaly Index of Severity [AIS] score, range 0–18), treatment satisfaction (Treatment Satisfaction Questionnaire for Medication [TSQM; range 0–100]) and quality of life (Acromegaly Quality of Life Questionnaire [AcroQoL; range 0–100]).

Results
Forty-three patients were included in the ACROINNOVA 2 extension safety analysis (DC n=20; restarted n=23); 41 (95.3%) received CAM2029 for ≥52W. CAM2029 was well tolerated; no new safety signals were observed. CAM2029-related adverse events (AEs) were reported by 17 (39.5%) patients; the most frequent were injection site AEs (12 [27.9%]). The efficacy analysis included 42 patients (DC n=19; restarted n=23). In the DC group, the observed IGF-I control rate increased from start to end of extension (73.7% [14/19] to 84.2% [16/19]). Notably, the IGF-I control rate in the restarted group decreased from core phase completion (60.9% [14/23]) to extension start (34.8% [8/23]). After restarting CAM2029, the observed IGF-I control rate increased to 59.1% (13/22) at the end of the extension. At extension start, mean (standard deviation) AIS Overall Score was 2.9 (2.9) in the DC group and 2.8 (2.5) in the restarted group; it remained stable for both groups at extension end (DC 2.3 [2.5], restarted 2.7 [2.2]). Mean TSQM convenience domain scores increased from start to end of the extension by 9.94 (95% confidence interval [CI] 3.23, 16.66) in the DC group and by 7.83 (95% CI 2.86, 12.79) in the restarted group. AcroQoL total score remained stable in both groups throughout the extension.

Conclusion
CAM2029 is an effective new long-term therapy for acromegaly, with a safety profile consistent with SoC. CAM2029 maintains biochemical control, sustains symptom control and enhances treatment satisfaction. When loss of control follows switch to SoC treatment, biochemical control can be regained with CAM2029.

*Unless otherwise noted, all abstracts presented at ENDO must not be released to the press or the public until the date and time of presentation. For oral presentations, the abstracts are embargoed until the session begins. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO.*