Searchable abstracts of presentations at key conferences in endocrinology
Endocrine Abstracts (2024) 99 EP320 | DOI: 10.1530/endoabs.99.EP320

ECE2024 Eposter Presentations Pituitary and Neuroendocrinology (214 abstracts)

An open-label long-term Phase 3 study of CAM2029 in patients with acromegaly (ACROINNOVA 2): interim analysis of the subgroup of patients ‘new to CAM2029’ with controlled or uncontrolled acromegaly on standard-of-care treatment

Diego Ferone 1 , Joanna L. Spencer-Segal 2 , Guzin Fidan Yaylali 3 , Mirjana Doknic 4 , Elena Isaeva 5 , Alexander Dreval 6 , Aleksandra Gilis-Januszewska 7 , Emre Gezer 8 , Irina Bancos 9 , Laurence Katznelson 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; 2Department of Internal Medicine and Michigan Neuroscience Institute, University of Michigan, Ann Arbor, MI, United States; 3Department of Endocrinology, Pamukkale University Faculty of Medicine, Denizli, Turkey; 4Clinic for Endocrinology, Diabetes and Metabolic Diseases, Clinical Centre Serbia, Medical Faculty of Belgrade, Belgrade, Serbia; 5Interregional Clinical Diagnostic Center, Kazan, Russian Federation; 6Endocrinology Department of Moscow Regional Research Clinical Institute, Moscow, Russian Federation; 7Department of Endocrinology, Jagiellonian University Medical College, Krakow, Poland; 8Department of Endocrinology and Metabolism, Kocaeli University Faculty of Medicine, Kocaeli, Turkey; 9Division of Endocrinology, Mayo Clinic, Rochester, MN, United States; 10Departments of Neurosurgery and Medicine, Stanford University School of Medicine, Stanford, CA, United States; 11Camurus AB, Lund, Sweden


Background: Acromegaly, a rare, chronic disorder, results from excessive growth hormone (GH) and insulin-like growth factor 1 (IGF-1). The need for convenient therapies that provide effective disease control led to the development of CAM2029, a novel, subcutaneous, octreotide depot designed for convenient monthly self-administration using pre-filled syringes/injection pens. In a 24-week Phase 3 trial (ACROINNOVA 1, NCT04076462) CAM2029 achieved superior IGF-1 control vs placebo (72.2 vs 37.5%; P=0.0018) in patients with acromegaly controlled with standard of care (SoC; octreotide long-acting repeatable/lanreotide Autogel) at screening. Interim data from another CAM2029 Phase 3 trial (52-week, open-label [ACROINNOVA 2; NCT04125836]) are reported here, focusing on patients ‘new to CAM2029’.

Methods: ACROINNOVA 2 enrolled patients from ACROINNOVA 1 (reported separately), and ‘new to CAM2029’ patients with controlled or uncontrolled IGF-1 (≤2x upper limit of normal [ULN]) on stable SoC for ≥3 months. New patients received once-monthly CAM2029 20 mg for up to 52 weeks. The primary endpoint was adverse events (AEs). Secondary endpoints included the proportion of patients with IGF-1 ≤1x ULN (weeks 50/52 mean); the combined IGF-1/GH response; IGF-1 change from baseline; severity score of acromegaly clinical signs/symptoms, assessed using the Acromegaly Index of Severity (AIS). Baseline values reflect SoC treatment.

Results: Eighty-one ‘new to CAM2029’ patients were enrolled. At data cut-off (23 May 2023), 61 patients completed treatment at week 52, 15 were ongoing and 5 had discontinued. No new or unexpected safety signals were observed. The most common treatment-emergent AEs were injection-site reactions: ‘new to CAM2029’, 38.3%; overall population, 43%; none were Grade 3. The proportion of patients achieving IGF/GH control increased during CAM2029 treatment (Table 1). Estimated IGF-1 response (linear probability model, patients with evaluable data at weeks 50/52) increased 21.9% (95% confidence interval [CI]: 9.6, 34.1) from baseline to weeks 50/52. AIS score significantly decreased from SoC baseline to week 52 (mean of –1.3 [95% CI: –2.1, –0.5]).

Table 1. Biochemical endpoints
Endpoint Baseline Weeks 50/52
n/Nall*(%)
IGF ≤x ULN (weeks 50/52 mean) 12/81 (14.8) 20/60 (33.3)
IGF ≤x ULN (weeks 50/52 mean) and GH <2.5 μg/l (week 52) 12/81 (14.8) 18/60 (30.0)
*Patients with evaluable data.

Conclusions: CAM2029 improved IGF-1/GH control and clinical symptoms in patients ‘new to CAM2029’. CAM2029 was well tolerated with a safety profile consistent with SoC. ACROINNOVA 2 reinforces the efficacy and safety of CAM2029 for treating acromegaly, including in patients with uncontrolled disease despite treatment with current SoC.

Volume 99

26th European Congress of Endocrinology

Stockholm, Sweden
11 May 2024 - 14 May 2024

European Society of Endocrinology 

Browse other volumes

Article tools

My recent searches

No recent searches.