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Checkpoint Therapeutics has announced the completion of enrollment for the metastatic cutaneous squamous cell carcinoma (cSCC) cohort.
FREMONT, CA: Checkpoint Therapeutics, Inc., clinical-stage immunotherapy and targeted oncology organization announces enrollment for the metastatic cutaneous squamous cell carcinoma (cSCC) cohort in its registration-enabling clinical trial cosibelimab, an anti-PD-L1 antibody.
Checkpoint announced in January 2020 that the FDA had approved the registration submission pathway for cosibelimab in metastatic cSCC focused on the current clinical trial, which has a target enrollment of almost 75 patients and a primary efficiency endpoint of verified objective response rate evaluated by independent central review. Top-line results are estimated in the fourth quarter of 2021. If successful, Checkpoint plans to submit a Biologics License Application (BLA) for cosibelimab in the first half of 2022, accompanied by a Marketing Authorization Application submission in Europe shortly after that. Checkpoint is also continuing to enroll a registration-enabling cohort of patients with locally developed cSCC, expecting that this second indication will be used on the planned BLA and MAA submissions next year.
James F. Oliviero, President and Chief Executive Officer of Checkpoint, stated, “We are pleased to report the completion of enrollment for our metastatic cSCC cohort, with over 75 patients enrolled, which we expect will enable a readout of top-line results in the fourth quarter of this year. Based on the interim data presented last year at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 and the Society for Immunotherapy of Cancer (SITC) 35th Anniversary Annual Meeting, we believe cosibelimab has the potential to be a best-in-class anti-PD-L1 antibody, which we intend to commercialize at a substantially lower price in comparison to currently marketed anti-PD-(L)1 therapies. With a compelling safety and efficacy profile, as well as our market disruptive pricing strategy, we believe cosibelimab can achieve meaningful and rapid market share in the $25 billion and growing PD-(L)1 class.”