Patients were given Merck’s Keytruda (pembrolizumab) in combination with platinum chemotherapy, Keytruda by itself or chemotherapy by itself. The trial results found that the combination extended survival, and immunotherapy alone also worked well for some patients.
JHVE Photo / Shutterstock
The Institute of Cancer Research (ICR), London, and The Royal Marsden NHS Foundation Trust presented clinical trial analysis at the American Society of Clinical Oncology (ASCO) Annual Meeting. The gist of the trial was that immunotherapy with chemotherapy, either by itself or in combination, is a more effective first-line treatment for head and neck cancer than standard aggressive chemotherapy.
The clinical trial involved 206 research centers worldwide. Patients were given Merck’s Keytruda (pembrolizumab) in combination with platinum chemotherapy, Keytruda by itself or chemotherapy by itself. The trial results found that the combination extended survival, and immunotherapy alone also worked well for some patients.
Patients with recurrent head and neck cancer typically receive two chemotherapy drugs and a targeted antibody treatment. Paul Workman, chief executive officer of the ICR, stated, “Immunotherapy has already revolutionized the outlook for patients with melanoma, and is showing huge promise in other cancer types as well. Based on the results of the new clinical trial, pembrolizumab looks set to do the same for people diagnosed with recurrent head and neck cancer. Until now, immunotherapy had only been tested in patients with head and neck cancer at a later stage of treatment, when other therapies had stopped working.”
The trial evaluated 882 patients with advanced head and neck cancer. Keytruda was given to 301 patients; 281 patients received immunotherapy and chemotherapy; 300 received chemotherapy.
Patients with high levels of PD-L1, which was observed in most patients, and who received the Keytruda-chemo combination, lived an average of 14.7 months. Patients receiving chemotherapy alone lived 11 months.
The data also indicated that 33% of patients with high levels of PD-L1 who received the combination therapy were still alive after three years compared to only 8% who received only chemotherapy. Of the patients who received only Keytruda, only 17% responded to treatment compared to 36% for patients who only received chemotherapy. But the patients who did respond to Keytruda in this cohort lived an average of 18.1 months longer than the cohort that received only chemotherapy.
“Patients with advanced head and neck cancer are currently given a highly aggressive chemotherapy combination, so I’m hopeful that the results of our trial will soon be translated into pembrolizumab approval on the NHS so patients can start benefiting right at the start of treatment,” stated Kevin Harrington, with the ICR and Royal Marsden. “We can imagine that many patients might be treated with pembrolizumab alone, allowing patients the twin benefits of prolonged survival and fewer side effects. Where necessary some might need to receive a combination of pembrolizumab and chemotherapy and we now know that this can be highly beneficial.”
One important aspect of the study was that compared to chemotherapy, Keytruda had significantly lower levels of serious adverse events, only 55% in patients receiving Keytruda alone. Side effect rates for the combination were 85% and for the aggressive chemo were 83%.
The UK’s National Institute for Health and Care Excellence (NICE) had begun analysis on whether Keytruda is cost-effective for use on the NHS. A decision is expected by February 2020.
