Buparlisib (AN2025) is an oral pan-P13K inhibiter that targets all class 1 P13K isoforms and is active in both hemafologic malignancies and solid tumors. It is being studied as a potential combination therapy with pactitaxel in hard-to-treat head and neck squamous cell carcinoma (HNSCC) and has received Fast-Track designation from the FDA.
It has shown promising efficacy in combination with paclitaxel in HNSCC and received a Fast-Track designation and an approval for initiating the phase III clinical study from FDA.
Head and Neck Squamous Cell Carcinoma (HNSCC)
HNSCC is a kind of head and neck tumor, it should include neck tumor, otolaryngology tumor and oral and maxillofacial tumor. HNSCC is the sixth most common cancer in the world, about 10% of all malignancies and more than 90% of squamous-cell carcinoma.
Although anti-PD-1 therapy has been approved by the FDA and EMA for the treatment of relapsed, refractory HNSCC, the response rate of listed PD-1 varieties is lower than 20%. There is still a large unmet medical need for the treatment of HNSCC with no response to PD-1.