On June 28, 2023 Checkpoint Therapeutics, Inc. ("Checkpoint") (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, reported that new pharmacokinetic ("PK") 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 Coruña, Spain (Press release, Checkpoint Therapeutics, JUN 28, 2023, View Source [SID1234632957]).
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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 in which cohorts of patients were dosed at either 800 mg every two weeks ("Q2W") or 1200 mg every three weeks ("Q3W"). 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 ("FDA") 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 ("BLA") for advanced cutaneous squamous cell carcinoma currently under review by the FDA with a Prescription Drug User Fee Act ("PDUFA") goal date of January 3, 2024.
These most recent results build on the previous presentation of PK and target occupancy data showing that cosibelimab doses of 800 mg Q2W and 1200 mg Q3W are both expected to achieve over 99% PD-L1 target occupancy throughout the respective dosing intervals to restore T-cell function in order to induce an anti-tumor response.
"We are firmly committed to improving all aspects of cancer care, including a focus on providing greater flexibility and convenience in administering cosibelimab upon its potential U.S. marketing approval in early January as a treatment for advanced cutaneous squamous cell carcinoma," said James Oliviero, President and Chief Executive Officer of Checkpoint. Mr. Oliviero continued, "These data further support the comparability of the two-week and three-week dosing regimens for cosibelimab and are included in the BLA submission currently under FDA review. If approved, based on its unique mechanism of action and compelling efficacy and safety profile, we believe cosibelimab has the potential to capture significant market share as a differentiated and possibly best-in-class treatment for patients with cutaneous squamous cell carcinoma, which we estimate to be a $1.6 billion U.S. market opportunity."
A copy of the poster presentation is available here.
Additional information on the meeting can be found on the PAGE website, www.page-meeting.org.