B32-10 Twice-yearly Depemokimab Is Well Tolerated Over 2 Years in Patients With Type 2 Asthma: An Integrated Safety Analysis of the Phase III SWIFT-1/-2 and the Open-label Extension AGILE Studies

Abstract Rationale Depemokimab is the first ultra-long-acting biologic, with enhanced interleukin-5 binding affinity, high potency, and extended half-life, enabling twice-yearly dosing in asthma. The safety and efficacy of depemokimab over 52 weeks in patients with type 2 asthma have been demonstrated in the Phase III SWIFT-1/-2 studies. Here, we assess the long-term safety of depemokimab over 2 years in an integrated post hoc analysis of the SWIFT-1/-2 and AGILE open-label extension (OLE) studies in patients with type 2 asthma. Methods Eligible adults with type 2 asthma characterized by blood eosinophil counts received subcutaneous depemokimab 100 mg or placebo at Weeks 0 and 26, up to 52 weeks, in SWIFT-1/-2. After completing SWIFT-1/-2, patients were invited to join the multicenter, single-arm AGILE OLE study, where all patients received depemokimab 100 mg for an additional 52 weeks, for a total follow-up period of 104 weeks. Here we present safety results, including adverse events (AE), serious AEs (SAE), and AEs of special interest (AESI; including allergic or other systemic reactions, and injection-site reactions), that were analyzed descriptively in patients who received depemokimab for the full 2-year period. Results Of the 502 patients randomized to receive depemokimab in SWIFT-1/-2, 419 (83%) patients entered the OLE and continued to receive depemokimab. Over the 2-year period, on-treatment AEs were reported in 86% of patients (Figure), of which COVID-19 (25%), nasopharyngitis (23%), and upper respiratory tract infection (16%) were most common. Treatment-related AEs (per investigator assessment) occurred in 6% of patients, with headache (1%), injection-site reaction (