Keytruda Receives New Head and Neck Cancer Indications
June 11, 2019 – The U.S FDA has approved two additional head and neck indications for Keytruda® (pembrolizumab), manufactured by Merck. The anti-PD-1 therapy is now indicated for use in combination with platinum and fluorouracil (FU) chemotherapy as a first-line treatment for patients who have metastatic or unresectable, recurrent head and neck squamous cell carcinoma (HNSCC). It is also indicated as a single agent for first-line treatment for metastatic or unresectable, recurrent HNSCC in patients whose tumors express PD-L1.
Head and neck cancers typically begin in the squamous cells lining the mucosal surfaces of areas such as the nose, mouth, and throat. Risk factors include tobacco and alcohol use (which account for approximately 75% of head and neck cancers) and cancer-causing forms of human papillomavirus (HPV). Approximately 4% of the cancers diagnosed in the U.S. are of the head and neck, with men twice as likely to develop head and neck cancers compared to women.
In a clinical trial, Keytruda used as a monotherapy or in combination with chemotherapy significantly improved overall survival (OS) compared to a regimen of cetuximab with carboplatin or cisplatin plus FU, a standard treatment. Keytruda as a monotherapy lowered the risk of death by 22% in PD-L1 positive patients. Used in combination with chemotherapy, Keytruda reduced the risk of death by 23% regardless of the patient’s PD-L1 status.
Recommended dosing for HNSCC is 200mg of Keytruda administered via intravenous infusion over the course of 30 minutes once every three weeks. Treatment should continue for up to 24 months or until disease progression or unacceptable toxicity. When used in combination with chemotherapy, Keytruda should be given first if the chemotherapy is to be administered on the same day.
First approved in 2016, Keytruda is indicated to treat 13 different forms of cancer. It holds a third HSNCC indication for use as a single agent to treat patients who have recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.