A new immunotherapy drug known as nivolumab greatly improves survival for patients with relapsed head and neck cancer, as more than twice as many patients taking it were alive after one year compared to those treated with chemotherapy. There are no other treatment options that improve the survival of patients with cisplatin-resistant relapsed or metastatic head and neck cancers, who typically live fewer than 6 months.
In fact, nivolumab was the first treatment to extend survival in a phase III clinical trial for patients with head and neck cancer in whom chemotherapy had failed, and it did so with fewer side effects than existing therapeutic notions. The trial was led by Kevin Harrington, PhD, of the Institute of Cancer Research (ICR), London, and the Royal Marsden National Health Service (NHS) Foundation Trust, with more than 20 research organizations from around the world.
Of the 361 patients in the trial, 240 with relapsed or metastatic head and neck cancer received nivolumab, while 121 received one of 3 different chemotherapies. In the United Kingdom, the chemotherapy patients received docetaxel, which is the only treatment approved for advanced head and neck cancer by the National Institute for Health and Care Excellence (NICE).
After one year of the study, 36% of patients treated with nivolumab were still alive, compared to 17% of the chemotherapy patients. The medial survival for patients on nivolumab was 7.5 months, compared to 5.1 months for chemotherapy.
Survival benefits were more pronounced in patients whose tumors had tested positive for human papillomavirus (HPV), with an average survival of 9.1 months compared to 4.4 months for those with chemotherapy. HPV negative patients survived an average of 7.5 months with nivolumab and 5.8 with chemotherapy.
Also, only 13% of patients taking nivolumab experienced serious side effects, compared to 35% of those with chemotherapy. Patients who received chemotherapy reported feeling physically, socially, and emotionally worse off, while those who received nivolumab remained stable during the course of treatment.
“Nivolumab could be a real game changer for patients with advanced head and neck cancer. This trial found that it can greatly extend life among a group of patients who have no existing treatment options without worsening quality of life,” said Harrington.
“Once it has relapsed or spread, head and neck cancer is extremely difficult to treat,” said Harrington. “So it’s great news that these results indicate we now have a new treatment than can significantly extend life, and I’m keen to see it enter the clinic as soon as possible.”
“Nivolumab is one of a new wave of immunotherapies that are beginning to have an impact across cancer treatment. This phase III clinical trial expands the repertoire of nivolumab even further, showing that it is the first treatment to have significant benefits in relapsed head and neck cancer,” said Paul Workman, PhD, ICR chief executive. “We hope regulators can work with the manufacturer to avoid delays in getting this drug to patients who have no effective treatment options left to them.”
Nivolumab still needs to be approved by the European Medicines Agency and NICE before it is available for head and neck cancer patients served by the NHS. The study, “Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck,” was published in The New England Journal of Medicine.