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Endocrine Abstracts (2024) 99 EP322 | DOI: 10.1530/endoabs.99.EP322

ECE2024 Eposter Presentations Pituitary and Neuroendocrinology (214 abstracts)

An open-label long-term Phase 3 study of CAM2029, an octreotide subcutaneous depot, in patients with acromegaly (ACROINNOVA 2): interim analysis of patient-reported outcomes

Diego Ferone 1 , Pietro Maffei 2 , Julie Silverstein 3 , Joanna L. Spencer-Segal 4 , Alexsandra Gilis-Januszewska 5 , Mirjana Doknic 6 , Pinar Kadioglu 7 , Pamela Freda 8 , Laurence Katznelson 9 , Guzin Fidan Yaylali 10 , Maria Harrie 11 , Agneta Svedberg 11 , Alberto M. Pedroncelli 11 & Fredrik Tiberg 11


1Endocrinology United, Department of Internal Medicine, IRCCS Ospedale Policlinico San Martino, Genova, Italy; 2University of Padua, Department of Medicine (DIMED), Padova, Italy; 3Division of Endocrinology, Metabolism and Lipid Research, Department of Neurosurgery, Washington University School of Medicine, St Louis, MO, United States; 4Department of Internal Medicine and Michigan Neuroscience Institute, University of Michigan, Ann Arbor, MI, United States; 5Department of Endocrinology, Jagiellonian University Medical College, Krakow, Poland; 6Clinic for Endocrinology, Diabetes and Metabolic Diseases, Clinical Centre Serbia, Medical Faculty of Belgrade, Belgrade, Serbia; 7Division of Endocrinology-Metabolism and Diabetes, Department of Internal Medicine, Istanbul University-Cerrahpasa, Istanbul, Turkey; 8Department of Medicine, Vagelos College of Physicians and Surgeons, Columbia University, New York, NY, United States; 9Departments of Neurosurgery and Medicine, Stanford University School of Medicine, Stanford, CA, United States; 10Department of Endocrinology and Metabolism Diseases, University of Pamukkale, Denizli, Turkey; 11Camurus AB, Lund, Sweden


Background: Significant treatment-related burdens accompany standard-of-care (SoC) therapies for acromegaly, which typically require healthcare-provider administration. CAM2029 is a novel, subcutaneous octreotide depot conveniently self-administered monthly by pre-filled syringe/injection pen. In a 24-week Phase 3 trial of CAM2029 in patients with acromegaly (ACROINNOVA 1, NCT04076462), insulin-like growth factor 1 (IGF-1) response was 72.2% in patients receiving CAM2029 vs 37.5% with placebo. Interim analysis of overall patient-reported outcomes (PROs) from a 52-week Phase 3 trial of CAM2029 (ACROINNOVA 2, NCT04125836) is reported here.

Methods: ACROINNOVA 2 enrolled patients completing ACROINNOVA 1 (24 weeks; prior-CAM2029 or prior-placebo) and new patients (IGF-1 ≤2x upper limit of normal [ULN] during stable SoC [octreotide long-acting repeatable/lanreotide Autogel]) to receive monthly CAM2029 20 mg for up to 52 weeks (28 weeks for prior-placebo group [week 24–52]). The primary endpoint was adverse events. Secondary PRO endpoints included Acromegaly QoL Questionnaire (AcroQoL), EQ-5D-5L visual analogue scale (VAS), Treatment Satisfaction Questionnaire for Medication (TSQM), Patient Satisfaction Scale (PSS) and the Self-injection Assessment Questionnaire (SIAQ v2.0). Higher scores indicate improvement.

Results: Enrolled patients (81 new, 36 prior-CAM2029, 18 prior-placebo) had a mean CAM2029 exposure of 56.3 weeks at data cut-off (23 May 2023). CAM2029 was well tolerated with no unexpected safety signals. From SoC baseline to week 52, mean scores increased for AcroQoL, EQ-5D-5L VAS, and TSQM (Table 1). SIAQ increased from SoC baseline to week 48 during CAM2029 treatment. Mean PSS (scale 0–5) at week 52 was 4.1 (95% confidence intervals [CI] 3.9, 4.3).

Table 1. PRO endpoints
AssesmentDomainMean change from SoC baseline (95% CI) at week 52
QoL: AcroQoLTotal score3.5 (1.3, 5.7)
Physical score1.9 (–0.5, 4.3)
Psychological total score4.4 (2.0, 6.8)
QoL: EQ-5D-5LVisual analogue scale3.2 (0.5, 5.9)
Treatment satisfaction: TSQMConvenience15.6 (11.8, 19.3)
Effectiveness6.3 (2.8, 9.8)
Satisfaction4.7 (1.1, 8.4)
Side effects2.4 (–2.0, 6.8)
Mean change from SoC baseline (95% CI) at week 48
Self-administration satisfaction: SIAQSatisfaction with current way of taking medication1.6 (0.9, 2.2)
Feelings about injections0.8 (0.3, 1.3)
Self-confidence0.8 (0.3, 1.4)

Conclusions: PRO scores indicated improvement in patients treated with CAM2029, including those previously controlled with SoC. The safety profile of CAM2029 was consistent with current SoC; no new safety signals were observed. These data support the clinical benefit of CAM2029 and its potential to address unmet needs for patients with acromegaly.

Volume 99

26th European Congress of Endocrinology

Stockholm, Sweden
11 May 2024 - 14 May 2024

European Society of Endocrinology 

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