Interim Phase III data presented yesterday at the American Association for Cancer Research Annual Meeting 2016 (16–20 April, LA, USA) indicate that nivolumab offers a significant survival benefit over standard chemotherapy in advanced head & neck cancer.
Individuals who received nivolumab lived significantly longer than patients who received standard chemotherapy, especially those testing positive for HPV. The results of this trial – the first to indicate efficacy of immunotherapy in the disease – open up a potential new treatment option within head & neck cancer, which is notably difficult to treat effectively.
“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,” commented UK trial leader Kevin Harrington of The Institute of Cancer Research (London, UK).
In the trial, 240 patients with relapsed or metastatic head & neck cancer were allocated to receive nivolumab, and 121 to one of three different chemotherapies.
After 1 year of the study, 36% of patients treated with nivolumab were still alive, compared with 17% in the chemotherapy arm. Median survival for patients on nivolumab was 7.5 months, compared with 5.1 months for chemotherapy.
Nivolumab was particularly effective in patients who had tested positive for HPV. In the 179 patients known to be HPV positive, median survival was 9.1 months with nivolumab and 4.4 months with chemotherapy. In HPV-negative patients, median survival was 7.5 months with nivolumab and 5.8 months with chemotherapy.
In terms of adverse effects, these were reported by 59% of the patients receiving nivolumab, compared with 77.5% of the patients receiving chemotherapy. In terms of serious adverse events, 13 and 35% reported severe side-effects with nivolumab and chemotherapy, respectively.
“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,” continued Harrington.