Results from a Phase 3 clinical trial revealed nivolumab is more effective than standard chemotherapy in prolonging the survival of patients with head and neck cancer, a notoriously difficult to treat disease once it spreads or relapses. The findings of the planned interim analysis, which potentially point to a treatment breakthrough, were presented at the 2016 American Association for Cancer Research Annual Meeting in New Orleans, by Ohio State University researchers.
Docetaxel, a chemotherapy drug, is the only treatment approved for advanced head and neck cancer by the National Institute for Health and Care Excellence (NICE) in the U.K. In the ongoing study, led in the U.K. by Professor Kevin Harrington of The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, researchers compared the therapeutic effects of docetaxel and the immunotherapy drug nivolumab, a checkpoint inhibitor monoclonal antibody that blocks PD-1 and stimulates immune T-cells.
The trial is the first demonstration of immunotherapy effectiveness for this malignancy, and found that patients taking nivolumab lived significantly longer than those on conventional chemotherapy. This finding was especially evident in people who tested positive for human papillomavirus (HPV), associated with the development of some head and neck cancers.
A total of 361 patients with relapsed or metastatic head and neck cancer were enrolled in the study, with 240 allocated to receive nivolumab and 121 given one of three different chemotherapies. After one year, 36 percent of patients receiving nivolumab were still alive, compared to 17 percent in other treatment arms. Median survival in the nivolumab group was also high compared to the chemotherapy group, 7.5 months versus 5.1 months, respectively. The efficacy of nivolumab treatment, again, was especially high among HPV-positive patients, with a survival time of 9.1 months, compared to 4.4 months in HPV-positive patients under chemotherapy. In HPV-negative patients, median survival was 7.5 months with nivolumab and 5.8 with chemotherapy. Side effects were observed in 59 percent of patients given nivolumab, and 77.5 percent of those receiving chemotherapy.
“This new trial is a potential game changer for head and neck cancer, introducing a new drug treatment into our armoury that at last is better than standard chemotherapy. Nivolumab is one of a new wave of immunotherapies that are beginning to have an impact across cancer treatment, and which will offer even greater promise in the future as we understand how best to use them,” Professor Harrington said in a news release.
In the United States, nivolumab has been approved by the U.S. Food and Drug Administration (FDA) to treat advanced melanoma, advanced renal-cell carcinoma, and advanced non-small cell lung cancer. The drug is available under the brand name Opdivo, and produced by Bristol Myers Squibb, which also funded the current U.K. study.