Immunotherapy drug approved for head and neck cancer
Some people with head and neck cancer will now have access to the immunotherapy drug pembrolizumab (Keytruda) on the NHS in England.
The drug was initially rejected in January due to uncertainties in the clinical trial data, but has now been approved by the National Institute of Health and Care Excellence (NICE) based on additional data. Pembrolizumab will now be an option for some adults whose cancer has either spread to other parts of the body or come back and cannot be removed surgically.
NICE estimates that around 950 people will be eligible for the treatment.
Who will the decision affect?
Pembrolizumab is an immunotherapy that aims to boost the immune system's ability to recognize and kill cancer cells. It works by blocking a molecule found on immune cells—called PD-1—from talking to cancer cells.
Currently, treatment for head and neck cancer in the NHS in England will depend on where the cancer started growing:
- If the cancer started inside the mouth, it's typically treated with a combination of a targeted cancer drug (cetuximab) and chemotherapy.drugs.
- If the cancer started outside the mouth, treatment usually includes a combination of chemotherapy drugs.
Pembrolizumab will now provide a new treatment option for both groups, but only if their cancer has spread to other parts of the body and they have not received any treatment, or if their cancer has returned and cannot be removed surgically. It would only be an option for patients whose tumors test positive for PD-L1.
Those taking pembrolizumab will also have to stop treatment after 2 years or earlier if their cancer progresses, according to the latest decision.
How do you know if a tumor is PD-L1 positive?
For head and neck cancer, researchers can calculate the percentage of PD-L1 positive cells within the tumor, which is reported as a combined positive score (CPS). A tumor is considered to be PD-L1 positive if it has a CPS score of more than 1.
NICE decisions are usually adopted in Wales and Northern Ireland as well as England, so pembrolizumab should now be available to patients in all 3 nations. Scotland has a separate process for reviewing drugs.
Clinical trial results and additional data
Results from clinical trials found that for people whose cancer started inside the mouth, pembrolizumab is at least as effective and has lower overall costs than the current cetuximab combination therapy. In people whose cancer started outside the mouth, pembrolizumab works better than chemotherapy on its own. While it has higher overall costs, the price is considered to be a cost-effective use of NHS resources.
Clinical trials also tested the benefits of using pembrolizumab in combination with chemotherapy drugs. But the cost-effectiveness estimates for pembrolizumab in combination with these drugs, which are currently the standard of care, are higher than NICE normally considers acceptable.
Therefore, following the submission of new data, NICE has recommended pembrolizumab as a solo treatment for these patients. It will not be available as a combination therapy.