Merck & Co – known as MSD outside the US and Canada – has announced that its anti-PD-1 therapy Keytruda (pembrolizumab) has been approved by the US Food and Drug Administration (FDA) to treat a new subset of adults with head and neck cancer.
The drug has been authorised for use as a single-agent neoadjuvant treatment before surgery, then continued after surgery in combination with radiotherapy (with or without cisplatin) as an adjuvant treatment, and then as a single agent.
Patients eligible for the regimen will have resectable locally advanced head and neck squamous cell carcinoma (HNSCC) and tumours expressing PD-L1 at a combined positive score of at least one, as determined by an FDA-approved test.
This is the first authorisation for HNSCC in six years and the first overall perioperative approval for locally advanced HNSCC, according to the FDA.
More than 72,680 new cases of head and neck cancer, which describes a number of different tumours that develop in or around the throat, larynx, nose, sinuses and mouth, are expected to be diagnosed in the US this year.
Keytruda works by increasing the ability of the body’s immune system to help detect and fight tumour cells, and is already approved in the US as a monotherapy and as part of a combination treatment for certain patients with metastatic or unresectable, recurrent HNSCC.
The regulator’s latest decision on the drug was supported by results from the phase 3 KEYNOTE-689 trial, in which the Keytruda perioperative regimen reduced the risk of disease recurrence, disease progression, or death by 30% compared to adjuvant standard of care (SOC) in PD-L1-positive patients.
Median event-free survival was 59.7 months in the Keytruda arm, compared to 29.6 months in the SOC cohort.
Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratorie, said: “As the first perioperative anti-PD-1 treatment option for appropriate patients with resectable locally advanced HNSCC, this new treatment regimen has the potential to shift the treatment paradigm for patients and their families affected by this disease.
“Based on these trial results, Keytruda as part of this regimen shows potential to change long-standing SOC for treating certain patients with locally advanced HNSCC.”
Marketing authorisation applications for Keytruda in this indication are currently under review by regulatory authorities worldwide, including in Europe.