No to Nivolumab

(May 4th, 2017) Although the medical benefits of the immunotherapy drug have been proven, patients in the UK will not receive it any time soon.

Last year, thanks to a major international phase III clinical trial, immunotherapy drug Nivolumab was the first to show positive results for patients with advanced neck and head cancer. However, in a rather surprising twist, in April, the UK’s National Institute for Health Care and Excellence (NICE), the executive non-departmental public body of the Department of Health, decided not to recommend its use as a standard treatment offered to cancer patients on the NHS.

As Lab Times featured recently, cancer immunotherapy treatments are designed to boost the body’s own abilities – in the form of the immune system – to fight cancer. There are several ways to achieve this but the most successful, so far, has been with the use of antibodies, such as Nivolumab. This drug essentially removes the “breaks” imposed on the immune system, and re-energises these cells to detect and kill cancerous cells. Under normal circumstances, these breaks – called immune checkpoints - are normal components of the immune system that act as ‘off-switches’ to prevent damage to healthy cells. Unfortunately, in many types of tumour, cancer cells acquire the ability to “trick” these checkpoints as a way to avoid being attacked and destroyed.

For Kevin Harrington, Professor of biological cancer therapies based at the Institute of Cancer Research in London and leader of the clinical trial, their results were incredibly encouraging. “Nivolumab is currently the only treatment shown in a phase III trial to improve survival for patients with relapsed or metastatic head and neck cancer – and it did so without worsening patients’ quality of life, and with fewer side-effects than standard treatment,” the researcher declared. “Overall, when compared with investigator’s choice of chemotherapy (docetaxel, methotrexate or cetuximab), nivolumab improved response rates, median overall survival and 12-month survival.”

From these positive results, NICE’s decision not to recommend Nivolumab came somewhat as a surprise. This means that, in the UK, the only treatment approved for patients with advanced head and neck cancer continues to be docetaxel, which actually showed poorer results in the clinical trial. “It is disappointing and frustrating that NICE’s decision means doctors will not be able to offer this immunotherapy to patients with advanced head and neck cancer,” says Harrington. “Once it has relapsed or spread, the disease is extremely difficult to treat and options, including surgery and radiotherapy, are very limited. It’s crucial that talks on the drug’s availability continue and ultimately that this decision is reversed, since otherwise patients face missing out on a genuinely effective treatment.”

It’s important to note that this was only a draft decision, with the final decision being made in the near future. Most importantly, this decision can be overturned if the drug is found to meet the cost-effectiveness threshold of £50,000 per additional year of life, which may involve discussions on how to reduce the cost of the drug to the NHS.

For Harrington, the best way forward to get Nivolumab accepted is to have a better understanding, of which patients are likely to gain from this treatment. “A clearer view of which patients are more likely to benefit - based on biomarker analyses such as PD-L1 levels, for example - would provide greater levels of confidence that treatment is likely to be efficacious and cost-effective,” concludes the researcher.

Work to assess Nivolumab’s applications also continues on other fronts. At the moment, this drug is being evaluated in patients that have not been treated with platinum-based chemotherapy. In this case, studies are ongoing to compare Nivolumab with either standard-of-care chemotherapy or the combination of Nivolumab plus Ipilimumab, another checkpoint-targeting antibody.

Alex Reis

Photo: Bristol Myers-Squibb

Last Changes: 05.23.2017