A clinical trial led by Yale Cancer Center (YCC) has produced data showing that pembrolizumab (Keytruda/Merck) increases the survival time of patients with advanced head and neck cancers.
With results recently published in The Lancet, YaleNews Anne Doerr recently reported updates.
The Study Results
The phase III study results were interpreted to represent “significantly improved” overall survival for patients with previously untreated recurrent or metastatic head and neck cancers. The KEYNOTE-048 trial involved hundreds of patients; sponsor Merck did not disclose any of the 200 participating clinical investigational sites names in Clinicaltrials.gov.
With 882 participants recruited by 200 medical centers in 37 countries, the patients were randomized to one of three groups including 1) those receiving pembrolizumab 2) those treated with pembrolizumab and chemotherapy and 3) those getting the standard therapy with cetuximab and chemotherapy.
Pembrolizumab (Keytruda), when used alone, increased the mean survival rate to 14.9 months as compared to 10.7 months for the standard therapy. Interestingly the use of pembrolizumab when combined with chemotherapy had a lower mean survival (13 months) when compared to pembrolizumab alone.
Principal Investigator Comments
YaleNews Doerr quoted the clinical trial’s lead investigator Barbara Burtness, MD, a professor of medicine (medical oncology) and co-leader of developmental therapeutics at Yale Cancer Center. Dr. Burtness noted, “This research demonstrates that this checkpoint inhibitor, with or without chemotherapy, should be the first drug used for these types of cancers.” She emphasized, “This is a very positive advance in treatment for our patients.”
KEYNOTE-048 results led to an FDA approval earlier in the year for Keytruda as first-line therapy in untreated recurrent or metastatic head and neck squamous cell carcinoma, which include cancers of the oral cavity, oropharynx, hypopharynx, and larynx.
Barbara Burtness, MD
Call to Action: For those that have a loved one diagnosed with advanced head and neck cancers, this study results may be of interest to discuss with their physician and oncologist.