Checkpoint announces confirmation of registration path for cosibelimab
Checkpoint Therapeutics announced that feedback from the U.S. Food and Drug Administration has confirmed the company's plan to submit cosibelimab for full approval as a treatment for patients with metastatic cutaneous squamous cell carcinoma based on efficacy and safety data from the ongoing open-label, multicenter, Phase 1 clinical trial, Study CK-301-101. This registration-enabling clinical trial is currently enrolling a cohort of patients with metastatic CSCC, with a target enrollment of approximately 75 to 100 patients and a primary efficacy endpoint of confirmed objective response rate assessed by independent central review. Positive interim results for cosibelimab were presented at the European Society for Medical Oncology Congresa 2019 in Barcelona, Spain. The poster presentation provided interim efficacy and safety results from the ongoing clinical trial, including a 50% ORR by investigator assessment in the first 14 evaluable patients in the metastatic CSCC cohort. One patient achieved a complete response and six patients achieved partial responses. All seven responses were confirmed and ongoing at the time of analysis. Additionally, cosibelimab appeared to be safe and well-tolerated in 81 treated patients with diverse tumor types. A copy of the ESMO Congress poster presentation is available on the Publications page of the Pipeline section of Checkpoint's website, www.checkpointtx.com.