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Endocrine Abstracts (2024) 99 EP321 | DOI: 10.1530/endoabs.99.EP321

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 the ACROINNOVA 1 roll-over patients subgroup

Diego Ferone 1 , Julie Silverstein 2 , Pamela Freda 3 , Laurence Katznelson 4 , Federico Gatto 1 , Pinar Kadioglu 5 , Pietro Maffei 6 , Jochen Seufert 7 , Joanna L. Spencer-Segal 8 , Elena Isaeva 9 , Alexander Dreval 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; 2Division of Endocrinology, Metabolism and Lipid Research, Department of Neurosurgery, Washington University School of Medicine, St. Louis, MO, United States; 3Department of Medicine, Vagelos College of Physicians & Surgeons, Columbia University, New York, NY, United States; 4Departments of Neurosurgery and Medicine, Stanford University School of Medicine, Stanford, CA, United States; 5Division of Endocrinology-Metabolism and Diabetes, Department of Internal Medicine, Istanbul University-Cerrahpasa, Istanbul, Turkey; 6Department of Medicine, Padua University Hospital, Padua, Italy; 7Division of Endocrinology and Diabetology, Department of Medicine II, Medical Faculty, University of Freiburg, Freiburg, Germany; 8Department of Internal Medicine and Michigan Neuroscience Institute, University of Michigan, Ann Arbor, MI, United States; 9Interregional Clinical Diagnostic Center, Kazan, Russian Federation; 10Endocrinology Department of Moscow Regional Research Clinical Institute, Moscow, Russian Federation; 11Camurus AB, Lund, Sweden


Background: Acromegaly is a neuroendocrine disorder, characterised by growth hormone (GH) and insulin-like growth factor 1 (IGF-1) overproduction. Persistent biochemical control to minimise adverse effects of prolonged excess GH/IGF-1 is a key treatment goal. CAM2029 is a novel octreotide depot, designed for convenient monthly subcutaneous self-administration, using pre-filled syringes/injection pens. A 24-week Phase 3 trial (ACROINNOVA 1, NCT04076462) evaluated CAM2029 in patients with acromegaly, controlled with standard of care (SoC; octreotide long-acting repeatable/lanreotide Autogel) at screening. CAM2029 met the primary endpoint, demonstrating superior IGF-1 control vs placebo (IGF-1 ≤upper limit of normal [ULN]: 72.2 vs 37.5%; P=0.0018). Interim analysis of patients who completed ACROINNOVA 1 and rolled over to the Phase 3, 52-week, open-label, long-term safety trial (ACROINNOVA 2, NCT04125836) is reported.

Methods: Patients received monthly CAM2029 20 mg for 28 weeks during ACROINNOVA 2. The primary endpoint was adverse events (AEs). Secondary endpoints included the proportion of evaluable patients with IGF-1 ≤1x ULN (weeks 50/52 mean); both IGF-1 ≤1x ULN (weeks 50/52 mean) and mean GH <2.5 µg/l (week 52); acromegaly clinical signs and symptoms severity score, assessed using the Acromegaly Index of Severity (AIS). Data are reported by treatment in ACROINNOVA 1; safety data are reported for the 52-week period.

Results: Of 64 patients completing ACROINNOVA 1, 54 entered ACROINNOVA 2 (prior-CAM2029, n=36; prior-placebo, n=18). CAM2029 was well tolerated. Fifty percent of patients (prior-CAM2029, 18/36; prior-placebo, 9/18) experienced injection-site treatment-emergent AEs (Grade ≤2). One serious treatment-related AE occurred in the prior placebo group (moderately severe cholelithiasis, resolved). In the prior-CAM2029 group, mean IGF-1 remained <ULN at weeks 50/52 in 89% of patients (Table 1). In the prior-placebo group, IGF-1 increased ≥1× ULN during ACROINNOVA 1; IGF-1 control was regained after switching to CAM2029. AIS score decreased significantly from SoC baseline to week 52 in prior-CAM2029 patients (–1.3 [95% CI: –2.3, –0.3]); in prior-placebo patients change in AIS score was –0.8 [95% CI: –2.1, 0.5]).

Table 1. Biochemical endpoints
EndpointPrior-CAM2029Prior-placebo
n/Nall* (%)
IGF ≤1x ULN (weeks 50/52 mean) 25/28 (89.3) 15/15 (100)
IGF ≤1x ULN (weeks 50/52 mean) and GH <2.5 µg/l (week 52) 23/26 (88.5) 14/14 (100)
*Patients with available data.

Conclusions: No new safety signals were observed; safety was consistent with SoC. CAM2029 provided persistent control of IGF-1/GH during treatment and improved clinical symptoms. Biochemical control of acromegaly was regained in placebo patients after switching to CAM2029.

Volume 99

26th European Congress of Endocrinology

Stockholm, Sweden
11 May 2024 - 14 May 2024

European Society of Endocrinology 

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