Advanced head and neck cancer that is resistant to chemotherapy is highly difficult to treat. However, an immunotherapy drug called nivolumab could be the game changer for patients with no treatment options.
An international phase III trial of head and neck cancer found more than twice as many patients taking nivolumab were alive after 1 year, as compared to patients undergoing chemotherapy.
The immunotherapy drug also resulted in fewer side effects than existing treatment options.
The trial researchers presented the findings at the European Society for Medical Oncology 2016 Congress in Copenhagen, Denmark; meanwhile the study was published in the New England Journal of Medicine.
Part of the trial was conducted in the United Kingdom, under the guidance of Kevin Harrington, professor of biological cancer therapies.
Prof. Harrington, who is also a consultant at The Royal Marsden National Health Service (NHS) Foundation Trust, comments:
“Once it has relapsed or spread, head and neck cancer is highly challenging to treat. So it’s great news that these results indicate we now have a new treatment that can significantly increase life, and I’m keen to see it enter the clinic as soon as possible.”
There are currently no other treatments that increase survival of patients with head and neck cancer that is resistant to cisplatin and has relapsed or spread (metastatic). Patients in this group are expected to live not more than 6 months.
‘Overall survival considerably extended with nivolumab’
Totally, 361 patients with relapsed or metastatic head and neck cancer took part in the trial, which was funded by Bristol Myers Squibb and involved 20 research centers all over the world.
The patients were randomly assigned (in a ratio of 2:1) to one of four treatment groups: 240 were administered nivolumab, and 121 were given one of three different chemotherapies.
After 12 months, 36 % of nivolumab administered patients were still alive, as compared to 17 % who were given chemotherapy.
Average survival for nivolumab patients was 7.5 months, as compared to 5.1 months for chemotherapy patients. The study authors note:
“Over-all survival was significantly longer with nivolumab than with standard therapy, and nivolumab-treated patients had a risk of death that was 30 % lower than the risk among patients assigned to standard therapy.”
Patients whose tumors tested positive for human papillomavirus (HPV) had the greatest survival rate. Those in this group survived for an average of 9.1 months on nivolumab, as compared to 4.4 months on chemotherapy.
Average survival for patients whose tumors were HPV-negative was 7.5 months for those on nivolumab and 5.8 months for those undergoing chemotherapy.
Another significant result was that relatively fewer patients (13 percent) experienced serious side effects from nivolumab, as compared to those undergoing chemotherapy (35 percent).
New wave of immunotherapy medicines
Nivolumab is one of a new wave immunotherapy drugs that is showing promising results in the cancer treatment.
Immunotherapy works by employing the immune system to combat cancer.
Nivolumab is a novel class of antibody drug known as checkpoint inhibitors; they prevent signals that cancer cells transmit to stop immune cells attacking them.
Nivolumab is not approved – neither in the United States (where it is known under the brand name Opdivo) nor in the U.K. – for the treatment of head and neck cancers, however it is approved for the treatment of other cancers such as melanoma.
Prof. Paul Workman, chief executive of the ICR, states: “We hope regulatory authorities can work with the manufacturer to avoid delays in getting this drug to patients who have no effective treatment options left to them.”
Usually, when a drug is approved for another use, the time from lab bench to clinic is significantly reduced as much of the evidence – for instance, regarding side effects and safety – is currently available, as compared to a completely new drug.
Commenting on study outcomes, Prof. Kevin Harrington said,
“Nivolumab could be a real game changer for patients with advanced head and neck cancer. This study found that it can significantly increase life among a group of patients who have no existing treatment options, without worsening quality of life.”