Sanofi and Regeneron’s Cemiplimab Receives FDA "Breakthrough Designation"
Cemiplimab (REGN2810) Granted FDA Breakthrough Therapy Designation for Advanced Cutaneous Squamous Cell Carcinoma
Sanofi and Regeneron jointly announced that Cemiplimab (REGN2810), an investigational human monoclonal antibody targeting PD-1, has been awarded FDA Breakthrough Therapy Designation for the treatment of Advanced Cutaneous Squamous Cell Carcinoma (CSCC). This designation highlights the potential of Cemiplimab in addressing this second deadliest form of skin cancer, which follows melanoma.
Positive preliminary results from two expansion cohorts, involving 26 advanced CSCC patients as part of a Phase 1 study comprising nearly 400 patients, have been reported. Building upon these promising findings, the ongoing EMPOWER-CSCC 1 Phase 2 clinical trial, a potentially pivotal study, is currently enrolling patients with metastatic CSCC and locally advanced and unresectable CSCC.
Treatment with Cemiplimab demonstrated an overall response rate of 46.2%, including two complete responses, nine partial responses, and one unconfirmed partial response. Additionally, the disease control rate was measured at 69.2%. These encouraging outcomes provide hope for patients suffering from CSCC, a challenging-to-treat condition that often leads to disfigurement due to repeated surgeries for tumor removal, especially in the head, neck, and other areas of the body. CSCC is responsible for the highest number of deaths among non-melanoma skin cancer patients.
It is important to note that Cemiplimab is currently under clinical development, and its safety and efficacy have yet to be fully evaluated by regulatory authorities. However, the Breakthrough Therapy Designation from the FDA signifies the significance of this potential treatment for advanced CSCC.
