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; Pietro Maffei; Julie Silverstein; Spencer-Segal Joanna L.; Alexsandra Gilis-Januszewska; Mirjana Doknic; Pinar Kadioglu; Pamela Freda; Laurence Katznelson; Yaylali Guzin Fidan; Maria Harrie; Agneta Svedberg; Pedroncelli Alberto M.; Fredrik Tiberg

doi:10.1530/endoabs.99.EP322

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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

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Author affiliations

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
Assesment	Domain	Mean change from SoC baseline (95% CI) at week 52
QoL: AcroQoL	Total score	3.5 (1.3, 5.7)
	Physical score	1.9 (–0.5, 4.3)
	Psychological total score	4.4 (2.0, 6.8)
QoL: EQ-5D-5L	Visual analogue scale	3.2 (0.5, 5.9)
Treatment satisfaction: TSQM	Convenience	15.6 (11.8, 19.3)
	Effectiveness	6.3 (2.8, 9.8)
	Satisfaction	4.7 (1.1, 8.4)
	Side effects	2.4 (–2.0, 6.8)
		Mean change from SoC baseline (95% CI) at week 48
Self-administration satisfaction: SIAQ	Satisfaction with current way of taking medication	1.6 (0.9, 2.2)
	Feelings about injections	0.8 (0.3, 1.3)
	Self-confidence	0.8 (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.