According to a story from Neuro Central, pharmaceutical company Merck has provided an update on its findings from its phase 3 clinical trial KEYNOTE-412. This clinical trial was evaluating pembrolizumab (marketed as Keytruda) in combination with chemoradiation therapy (followed by maintenance therapy with Keytruda) as a treatment for head and neck cancer that is locally advanced. The approach failed to achieve its end-point survival primary endpoint. While patients that received the treatment did see some improvement compared to placebo, the findings did not achieve statistical significance according to trial parameters.
About Head and Neck Cancer
The vast majority of cases of head and neck cancer are a type called squamous cell carcinoma (SCC). This type can appear on the skin and within the lining of many hollow organs, such as those of the digestive and respiratory systems. The throat, nasal cavity, and mouth are also possible locations where this cancer can form. There are a number of risk factors for this cancer, such as tobacco, alcohol, betel nuts, gastroesophageal reflux, stem cell transplant, HPV, Epstein-Barr virus, and a diet heavy in red meat, processed meat, and eggs. Symptoms include breathing difficulties, facial swelling, a sore throat that doesn’t heal, a lump or sore that doesn’t heal, bleeding, vocal changes, and difficulty swallowing. Treatments include targeted therapies, chemotherapy, surgery, radiation therapy, and photodynamic therapy. To learn more about head and neck cancer, click here.
About The Trial
It should be noted that Keytruda is already approved around the world for metastatic or unresectable head and neck cancer, both alone and as part of a combined approach. However, the results from this trial mean that Keytruda’s role in the treatment of this cancer won’t be expanding any time soon to earlier stages. The trial recruited 780 patients that has been recently diagnosed. Patients either received a 200 mg dose of Keytruda along with chemoradiation (in this regimen, cisplatin and radiation), followed by a year of maintenance with Keytruda, or a placebo combined with chemoradiation and a year of placebo.
