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 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 today (Tuesday) 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.
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.
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 NICE.
Researchers from Ohio State University presented results of the planned interim analysis at the conference.
After one year of the study, 36 per cent of patients treated with nivolumab were still alive at one year compared with 17 per cent 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 per cent of patients on nivolumab had side effects, compared with 77.5 per cent of patients on chemotherapy. Some 13 and 35 per cent had severe side-effects with nivolumab and chemotherapy respectively.
UK trial leader Professor Kevin 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."
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Notes to editors
For more information please contact Henry French on 020 8722 5582 or henry.french@icr.ac.uk. For enquiries out of hours, please call 07595 963 613.
1. More than 11,000 new cases of head and neck cancer are diagnosed in the UK each year, and it causes around 3,300 deaths. The Rich Picture: People with Head and Neck Cancer. Macmillan 2014. Accessed online April 2016.
2. The trial was in patients with cancers which began in the 'squamous' cells lining the oral cavity or the larynx or pharynx, and had returned or spread after initial treatment with a mix of chemo- or radiotherapy or surgery. Squamous cell carcinoma accounts for the majority of head and neck tumours.
3. Nivolumab is one of three immunotherapeutic drugs available on the NHS for advanced melanoma, and is currently under evaluation for non-small cell lung cancer.
The Institute of Cancer Research, London, is one of the world's most influential cancer research institutes.
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