7377 CAM2029, Octreotide Subcutaneous Depot, Improves Patient-Reported Outcomes From Standard-of-Care Baseline in Patients With Acromegaly: Interim Results From a Phase 3 Study (ACROINNOVA 2)
Authors: Ferone Diego , Maffei Pietro , Silverstein Julie , Spencer-Segal Joanna L , Gilis-Januszewska Aleksandra , Doknic Mirjana , Kadioglu Pinar , Freda Pamela , Katznelson Laurence , Yaylali Guzin Fidan , Harrie Maria , Svedberg Agneta , Pedroncelli Alberto M , Tiberg Fredrik 
Published: October 2024

Abstract
Disclosure: D. Ferone: Consulting Fee; Self; Camurus AB, Ipsen, Novartis-AAA, Recordati. Grant Recipient; Self; Camurus AB, Ipsen, Novartis-AAA, Recordati. Research Investigator; Self; Camurus AB. P. Maffei: Research Investigator; Self; Camurus AB. J. Silverstein: Consulting Fee; Self; Xeris Pharmaceuticals. Research Investigator; Self; Camurus AB. J.L. Spencer-Segal: Advisory Board Member; Self; Camurus AB. Research Investigator; Self; Camurus AB. A. Gilis-Januszewska: None. M. Doknic: Speaker; Self; Pfizer, Inc., Novo Nordisk, Merck, Sandoz. P. Kadioglu: None. P. Freda: Research Investigator; Self; Camurus AB. L. Katznelson: Advisory Board Member; Self; Camurus AB, Recordati. G. Fidan Yaylali: None. M. Harrie: Employee; Self; Camurus AB. Stock Owner; Self; Camurus AB. A. Svedberg: Employee; Self; Camurus AB. Stock Owner; Self; Camurus AB. A.M. Pedroncelli: Employee; Self; Camurus AB. Stock Owner; Self; Camurus AB. F. Tiberg: Employee; Self; Camurus AB. Stock Owner; Self; Camurus AB.
Introduction: Standard-of-care (SoC) therapies for acromegaly typically require healthcare provider administration and can pose a significant treatment burden. CAM2029 is a novel subcutaneous octreotide depot designed for convenient once-monthly self-administration as a ready-to-use syringe or injection pen. In a 24-week Phase 3 trial (ACROINNOVA 1), CAM2029 achieved superior insulin-like growth factor 1 (IGF-1) response vs placebo in acromegaly patients (pts) previously controlled with SoC (octreotide LAR/lanreotide Autogel). We report patient-reported outcome (PRO) data from an interim analysis of a Phase 3, open-label trial of CAM2029 (ACROINNOVA 2; NCT04125836). Methods: ACROINNOVA 2 enrolled pts with acromegaly who completed ACROINNOVA 1 (prior CAM2029 or placebo groups) and new pts with IGF-1 ≤2x upper limit of normal during stable SoC. Pts received once-monthly CAM2029 20 mg for up to 52 weeks (28 weeks for prior placebo pts [week 24−52]). Primary endpoint was adverse events. PROs were assessed using Acromegaly Index of Severity (AIS, 0−18; sum of 6 scores [0−3; none−severe] for headache, sweating, fatigue, joint pain, paresthesia, soft tissue swelling) for symptoms; Acromegaly Quality of Life Questionnaire (AcroQoL, 0−100) for QoL; Treatment Satisfaction Questionnaire for Medication (TSQM, 0−100) and patient satisfaction scale (0−5) for treatment satisfaction; and Self-Injection Assessment Questionnaire (SIAQ v2.0, 0−10) for satisfaction with self-administration. Higher scores signify improvements, except for AIS. Data are shown for the overall population. Results: At data cutoff (May 23, 2023), 54 roll-over pts (prior CAM2029 n=36; prior placebo n=18) and 81 new pts were enrolled; mean CAM2029 exposure was 56.3 weeks. CAM2029 was well tolerated with no unexpected side effects. Mean AIS score improved from baseline SoC to week 52 (−1.2; 95% CI: −1.8, −0.7); estimated proportion of pts with any acromegaly symptoms reduced by 15.1% (95% CI: −23.9, −6.3). At week 52 vs baseline: mean total AcroQoL increased by 3.5 (95% CI: 1.3, 5.7); mean TSQM increased for ‘convenience’ by 15.6 (95% CI: 11.8, 19.3), ‘effectiveness’ by 6.3 (95% CI: 2.8, 9.8), ‘satisfaction’ by 4.7 (95% CI: 1.1, 8.4), and for ‘side effects’ by 2.4 (95% CI: −2.0, 6.8). Mean patient satisfaction score at week 52 was 4.1 (95% CI: 3.9, 4.3); 32.6% and 19.3% of pts reported a ‘much better’ or ‘slightly better’ experience, respectively, with CAM2029 vs prior SoC. Mean SIAQ increased at week 48 vs pre-treatment, ‘satisfaction with way of taking medication’ by 1.6 (95% CI: 0.9, 2.2) and ‘feelings about injections’ by 0.8 (95% CI: 0.3, 1.3). Conclusion: CAM2029 improved symptom burden, QoL, treatment convenience, and patient satisfaction vs baseline SoC, including in pts with stable or controlled disease at baseline, supporting the clinical benefit of CAM2029 and its potential to address unmet needs for pts with acromegaly.
Presentation: 6/2/2024