Photo: Jan Chlebik for the ICR
The immunotherapy drug nivolumab has become the first to show a survival benefit in head and neck cancer, after a major international trial found that it was more effective than standard chemotherapy.
Patients taking nivolumab were more than twice as likely to be alive after one year of the trial as those treated with chemotherapy, according to data presented at the American Association of Cancer Research annual meeting 2016 in New Orleans.
The phase III trial has opened up a new treatment option for head and neck cancer – which is notoriously difficult to treatment – and is the first to demonstrate the effectiveness of an immunotherapy for the disease.
The ongoing international trial is led in the UK by Professor Kevin Harrington of The Institute of Cancer Research, London, and The Royal Marsden NHS Foundation Trust, and involves 361 patients and 20 research organisations. It is funded by Bristol Myers Squibb.
Interim results presented on Tuesday 19 April 2016 show patients taking nivolumab lived significantly longer than those on chemotherapy – particularly those testing positive for human papillomavirus (HPV), which is linked to the development of some head and neck cancers.
Hundreds in trial
Head and neck cancer affects areas including the nasal and oral cavities, and is relatively common – with around 11,000 new cases and 3,300 deaths in the UK each year [PDF].
In the trial, 240 patients with relapsed or metastatic head and neck cancer were allocated to receive nivolumab and 121 to one of three different chemotherapies.
UK patients – the majority of whom were treated at The Royal Marsden – received the chemotherapy drug docetaxel, which is the only treatment approved for advanced head and neck cancer by the UK’s National Institute for Health and Care Excellence.
Researchers from Ohio State University presented results of the planned interim analysis at the conference.
After one year of the study, 36% of patients treated with nivolumab were still alive at one year compared with 17% for the comparator 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 the HPV virus. 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 with chemotherapy.
Some 59% of patients on nivolumab had side-effects, compared with 77.5% of patients on chemotherapy. Some 13% and 35% had severe side-effects with nivolumab and chemotherapy respectively.
Professor Harrington, Professor of Biological Cancer Therapies at The Institute of Cancer Research, London, and Consultant at The Royal Marsden NHS Foundation Trust, said: “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.
“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.”