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Copanlisib + cetuximab is a combination therapy being investigated for the treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). Copanlisib is an intravenous, pan-class I PI3K inhibitor with predominant activity against the PI3Kα and PI3Kδ isoforms, developed by Bayer. Cetuximab is a monoclonal antibody targeting the epidermal growth factor receptor (EGFR). The combination is specifically being evaluated in patients whose tumors harbor PI3KCA mutations, PI3KCA amplification, or PTEN loss, as these alterations are common in HNSCC and contribute to resistance against EGFR inhibitors. By simultaneously blocking the EGFR and PI3K pathways, the regimen aims to restore sensitivity to treatment and improve outcomes in patients who have progressed after platinum-based chemotherapy.
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