Checkpoint Therapeutics announces presentation of new cosibelimab data

Checkpoint Therapeutics announced that new pharmacokinetic modeling data on cosibelimab supporting the extension to an every-three-week dosing regimen were presented today at the Population Approach Group Europe, PAGE, 2023 annual meeting, taking place in A Coruna, Spain. The poster presentation, entitled “Population Pharmacokinetic Analysis of PD-L1 Checkpoint Inhibitor Cosibelimab in Subjects with Advanced Cancers,” compares cosibelimab exposures from over 200 patients enrolled in the multicenter, multiregional pivotal trial of cosibelimab. The patient exposure results provide evidence that cosibelimab dosed at 800 mg Q2W and 1200 mg Q3W intervals are comparable based on the PK-related criteria outlined in U.S. Food and Drug Administration guidance for supporting alternative dosing regimens for PD-L1 antibodies. These data support the proposed 1200 mg Q3W commercial dosing regimen for cosibelimab included in the Biologics License Application for advanced cutaneous squamous cell carcinoma currently under review by the FDA with a Prescription Drug User Fee Act goal date of January 3, 2024.