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The addition of Keytruda to chemoradiation, followed by maintenance Keytruda, did not lead to a statistically significant event-free survival benefit in patients with locally advanced head and neck squamous cell carcinoma.
Treatment with Keytruda (pembrolizumab) plus chemoradiation therapy followed by maintenance Keytruda failed to significantly improve outcomes for patients with unresected locally advanced head and neck squamous cell carcinoma compared with those given placebo plus chemoradiation, according to Merck, the manufacturer of the immunotherapy agent.
Findings from the phase 3 KEYNOTE-412 clinical trial showed that there was a slight benefit in came to event-free survival (time a patient lives after therapy without their disease coming back or getting worse).
However, the improvement in event-free survival was not statistically significant, meaning that study investigators could not definitely say that it was the Keytruda (rather than chance or other factors) that led to the boost in outcomes.
“There have been limited advances for patients with locally advanced (head and neck squamous cell carcinoma) and unfortunately, these results suggest that this disease remains very challenging to treat,” Dr. Eliav Barr, chief medical officer of Merck Research Laboratories, said in a press release.
KEYNOTE-412 involved 780 adults with newly diagnosed oropharyngeal or larynx/hypopharynx/oral cavity squamous cell carcinoma.
Study participants were randomly assigned to receive 200 mg of Keytruda every three weeks plus chemoradiation (cisplatin plus radiation) then Keytruda maintenance therapy, which is given to prevent the recurrence or spread of cancer that has been treated, for about one year; or to receive placebo plus chemoradiation followed by placebo.
Updated results from the trial are expected to be presented at an upcoming medical conference.
Keytruda, which is approved for the treatment of multiple other solid tumors, will continue to be studied for certain patients with head and neck cancer. Of note, last month the Food and Drug Administration (FDA) granted a fast-track designation to the novel agent PDS0101 plus Keytruda for HPV16-positive head and neck cancer.
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