Alpelisib Plus Cetuximab may be Effective for Patients with Cetuximab-Resistant Head and Neck Cancer

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According to new findings presented at the American Association for Cancer Research (AACR) special conference Targeting the PI3K-mTOR Network in Philadelphia, Pennsylvania, alpelisib, also known as BYL719, was an effective treatment in combination with cetuximab in patients with cetuximab-resistant head and neck cancer.


In the phase 1b study, researchers enrolled 37 patients with recurrent or metastatic squamous cell carcinoma of the head and neck with previous resistance to platinum-based chemotherapy. Of those, five patients took alpelisib 400 mg once daily plus cetuximab and 32 patients took alpelisib 300 mg once daily alone.


Among all patients, the overall response rate was 11% with a 54% disease control rate. Of the patients that received alpelisib alone, four patients achieved a confirmed partial response and 16 patients had stable disease. In addition, one of the seven patients who had relapsed on prior cetuximab therapy achieved a partial response and five had disease control.


Based on the results of this study, researchers are currently conducting a phase 2 trial to study alpelisib 300 mg once daily in combination with cetuximab in patients with squamous cell carcinoma of the head and neck.

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BYL719, an effective treatment in combination with cetuximab in patients head and neck cancer.

The investigational drug alpelisib, previously known as BYL719, was able to overcome head and neck cancer resistance to the anti-EGFR treatment cetuximab, and combining alpelisib with cetuximab was found to be beneficial, according to data from a phase Ib/II trial presented at the AACR special conference Targeting the PI3K-mTOR Network in Cancer, held Sept. 14-17.

"Most of head and neck cancers are driven by activation of the EGFR pathway. Cetuximab is a drug that targets EGFR and is effective in this setting, but cancers often become resistant to this therapy," said Pamela Munster, MD, professor of medicine and director of the Early Phase Clinical Trials Unit at the UCSF Helen Diller Family Comprehensive Cancer Center. "Treatment resistance is often conveyed through activation of the PI3K/AKT/mTOR pathway, and alpelisib is an inhibitor of this pathway."

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