The US Food and Drug Administration (FDA) has approved a new treatment for adults with advanced skin cancer, specifically metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC). The immune checkpoint inhibitor cosibelimab (Unloxcyt; Checkpoint Therapeutics, Inc.) is the first of its kind to be approved for this type of cancer.
The FDA approval was based on a clinical trial involving 109 patients with CSCC. In the trial, 47% of patients with metastatic disease and 48% of those with locally advanced disease responded to the treatment. The median duration of response in treated patients was 17.7 months for those with local disease.
Common side effects of cosibelimab include fatigue, musculoskeletal pain, rash, diarrhea, and nausea. However, the treatment offers a unique approach by binding to PD-L1 rather than programmed death receptor-1 (PD-1), which may provide a more targeted effect.
The treatment is considered an important new option for US oncologists treating CSCC patients. According to Dr. Emily Ruiz, academic director of the Mohs and Dermatologic Surgery Center at Brigham and Women’s Hospital, CSCC is the second most common form of skin cancer, and those diagnosed with advanced disease often face a poor prognosis.
Cosibelimab has been shown to induce antibody-dependent cell-mediated cytotoxicity, a potential differentiating feature compared to existing treatments for CSCC. The treatment’s dual mechanisms of action and safety profile make it an attractive option for US oncologists.
Source: https://www.medscape.com/viewarticle/fda-approves-cosibelimab-cutaneous-scc-2024a1000n94?form=fpf