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New one-year results for Kodiak's tarcocimab tedromer in the pivotal BEACON trial reinforce durability signal and demonstrate matched efficacy and comparable safety and tolerability in retinal vein occlusion
Tarcocimab demonstrated strong durability, matched efficacy and comparable safety versus aflibercept in a head-to-head comparative pivotal trial over
About this update from Kodiak Sciences Inc
[{"type":"text","content":"Tarcocimab demonstrated strong durability, matched efficacy and comparable safety versus aflibercept in a head-to-head comparative pivotal trial over one-yearAfter 4 initiating doses in the first 6 months, approximately half of tarcocimab-treated patients required no additional injections in the second 6 monthsLow and comparable rates of cataract adverse events were observed (tarcocimab 4.9% vs aflibercept 2.8%)These results provide additional supportive evidence for the development of Kodiak's ABC Platform and platform-derived medicinesPALO ALTO, Calif., Sept. 7, 2023 /PRNewswire/ -- Kodiak Sciences Inc. (NASDAQ: KOD) today announced top-line, one-year (48 weeks) results for its ABC Platform based investigational therapy tarcocimab tedromer 5 mg from the pivotal BEACON study in patients with macular edema due to retinal vein occlusion (RVO).\nMacular edema due to retinal vein occlusion affects approximately 16.4 million adults worldwide and 1.1 million in the United States. Standard of care therapeutic agents are approved for monthly injections.\nBEACON is a randomized, double-masked, multicenter, active comparator-controlled Phase 3 clinical trial in treatment naïve patients with vision loss and macular edema due to retinal vein occlusion, including both branch (BRVO) and central (CRVO) subtypes. BEACON randomized 568 participants 1:1 into two treatment arms: tarcocimab tedromer 5 mg versus aflibercept 2mg.\nIn the initial six months of the study, patients received Kodiak's tarcocimab tedromer 5 mg on a fixed every 8-week dosing regimen following only 2 monthly loading doses or aflibercept 2 mg on a fixed monthly (every 4-week) dosing regimen per its label.\nIn the second six months of the study, tarcocimab and aflibercept were tested head-to-head according to a pro re nata (PRN) protocol in which patients in both groups were treated only when disease reactivated according to matched predefined disease activity criteria.\nThe results were:\nDifferentiated Durability and Matched Efficacy Outcomes:\nTarcocimab showed matched efficacy with differentiated durability versus aflibercept in the head-to-head comparison.After 4 initiating doses in the first 6 months, 47% of tarcocimab-treated patients required no additional injections in the second 6 months (while matching the vision and anatomic outcomes of aflibercept-treated patient...