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]).
| Endpoint | Prior-CAM2029 | Prior-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.
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Endocrine Abstracts
ISSN 1470-3947 (print) | ISSN 1479-6848 (online)
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