Sanford Health has announced the findings from a Phase 1b study using pembrolizumab (Keytruda®) in addition to the standard chemotherapy and radiation treatment for patients with head and neck cancers. The results from this first-in-human trial have been published in the Journal of Clinical Oncology.
"In a matter of four years, we've taken research from the bench and brought a promising new treatment to our patients' bedside," said Steven Powell, MD, principal investigator for the study. "Head and neck cancers are tough to beat, and the results of this study bring us one step closer to finding a better treatment to cure our patients and improve their quality of life," said Powell who is also a medical oncologist at Sanford Health and associate scientist at Sanford Research.
Head and neck cancers are the 6th most common cancer worldwide. According to the U.S. Centers for Disease Prevention and Control (CDC), 70 percent of head and neck cancers are caused by the human papilloma virus (HPV), and an estimated 13,500 people are diagnosed with HPV-positive head and neck cancers every year.
The study was led by the Sanford head and neck cancer team and included treatment centers in the Dakotas. The study was also expanded to include collaborators at the University of California San Diego. The researchers observed the progression and survival rates for 59 patients enrolled in the trial, especially those with HPV-positive head and neck cancers. The HPV-positive patients who were part of the trial had a 97% two-year survival rate, which is favorable compared to current standard treatment.
The study also evaluated for the first time the safety and efficacy of adding Keytruda® to the standard chemotherapy and radiation regimen for patients with head and neck cancers. The drug was well-tolerated and safe.
"By giving a simple protein through intravenous infusion to activate the immune system, we were able to enhance immune response during a difficult treatment course, without adding substantial toxicity for the patient," said Powell. Normally, 77% of patients who receive chemotherapy for head and neck cancers have very serious side effects, he said.
Many patients diagnosed with head and neck cancers cannot have surgery to remove the tumor because the tumor is too large or the resulting surgery would have unacceptable loss of important structures in the throat and neck. The standard of care for advanced head and neck cancers is to provide chemotherapy and radiation.
Sanford Health's team of world-renowned researchers led by Powell submitted a proposal to Merck, the manufacturer of Keytruda®, in 2014 to use the lab version of the immunotherapy drug in mouse models for head and neck cancers. Mouse models can show how the immune system interacts with drugs. The Sanford Research team wanted to a find a safe regimen that would cure more head and neck cancers. Powell and his team looked at what happened in the mouse models when Keytruda® was added early on in combination with chemotherapy and radiation. The findings in the mouse models were encouraging – the drug activated the immune system and was more successful at curing the cancer.
In 2015, Powell and the Sanford Research team received approval from Merck and the FDA to launch the clinical trial in an effort to help Sanford patients access this treatment. The study opened to an initial group of patients in 2016 and expanded in 2017 when the results showed early promise. Now these clinical trial results have led to several international phase III clinical trials using this approach.
W. Chad Spanos, MD, a senior author of the study, and a surgeon-scientist at Sanford Health who leads the head and neck cancer team underscored the significance of the study's findings. "This approach – looking at a drug's ability to activate the body's immune system to fight head and neck cancers – is now being studied in large international trials to determine if it will become the new standard of care," said Spanos. "The trial conducted with the participation of patients in the Midwest could change the trajectory of how we treat and care for head and neck cancer patients around the world."
The study will follow patients for five years and will collect blood and tumor samples to better understand how an individual's genetic predisposition may affect the efficacy of the immunotherapy treatment. This research is ongoing at the Sanford Research Laboratories and is supported by a five-year, nearly $11.7 million grant from the National Institutes of Health.
Earlier this month, the Food and Drug Administration (FDA) approved Gardasil 9, the HPV vaccine, to prevent head and neck cancers. Men are three times more likely to be diagnosed with HPV-positive head and neck cancers.Back To Top
Study Finds Keytruda With Chemotherapy, Radiation Enhances Outcomes for Head and Neck Cancers. Appl Rad Oncol.