Drug intelligence / Profile preview

copanlisib + cetuximab

Development stage
Phase 2
Lead developer
Bayer
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics, Small Molecules
Administration
Intravenous
01

Overview

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.

Other names
copanlisib and cetuximab combinationcopanlisib plus cetuximab
02

Targets

EGFR (Epidermal growth factor receptor)PIK3CB (Phosphatidylinositol 3-kinase beta subunit)PIK3CD (Phosphatidylinositol 3-kinase delta)PIK3CG (Phosphatidylinositol 4,5-bisphosphate 3-kinase gamma)PIK3CA (Phosphoinositide 3-kinase alpha)

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