The immunotherapy drug nivolumab conferred a survival benefit in patients with head and neck cancer over standard chemotherapy, according to study results presented at the American Association for Cancer Research (AACR) 2016 Annual Meeting.1

In this phase III trial (CheckMate-141), patients who took nivolumab were more than twice as likely to be alive compared with patients who received chemotherapy 1 year after the trial. Head and neck cancer is particularly challenging to treat, and these results are the first demonstrating an immunotherapy as effective in treating the disease. In addition, the increased survival was particularly pronounced in patients with HPV-positive head and neck cancer.

Patients with relapsed or metastatic head and neck cancer were given either nivolumab (n = 240) or 1 of 3 different chemotherapies (n = 121). More than one-third (36%) of patients treated with nivolumab were still alive at 1 year whereas only 17% of patients treated with chemotherapy were still alive at 1 year.

Continue Reading

Median survival for patients on nivolumab was 7.5 months, and median survival for patients on chemotherapy was 5.1 months.

In patients with HPV-positive disease (n = 179), those on nivolumab experienced median survival of 9.1 months, whereas those on chemotherapy experienced median survival of 4.4 months. Median survival in HPV-negative patients was 7.5 months with nivolumab and 5.8 months with chemotherapy.

Only 59% of patients on nivolumab experienced side effects, compared with 77.5% of patients on chemotherapy. Severe side effect rates were also lower in the nivolumab arm: 13% of patients experienced severe side effects compared with 35% of patients receiving chemotherapy.

“This new trial is a potential game changer for head and neck cancer, introducing a new drug treatment into our armory 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,” said Kevin Harrington, MD, PhD, professor of biological cancer therapies at The Institute of Cancer Research, London, England, and consultant at The Royal Marsden NHS Foundation Trust, and leader in the trial.

“Once it has relapsed or spread, head and neck cancer is extremely difficult to treat, with surgery and radiotherapy often impossible. So it’s very good news for patients that these interim results indicate we now have a new treatment that works, and can significantly extend life.”

Bristol-Myers Squibb funded this study.


1. Gillison ML, Blumenschein G Jr, Fayette J, et al. Nivolumab (nivo) vs investigator’s choice (IC) for recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC): CheckMate-141. Plenary session at: American Association for Cancer Research 2016 Annual Meeting; April 16-20,2016; New Orleans, LA.