National Institute for Health and Clinical Excellence (NICE)
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NICE draft guidance does not recommend pembrolizumab plus chemotherapy for triple negative breast cancer

Draft guidance published today (8 March 2022) by NICE for public consultation does not recommend pembrolizumab plus chemotherapy for treating triple negative breast cancer that has spread to other parts of the body

The evidence showed that pembrolizumab plus chemotherapy is more effective than paclitaxel or nab-paclitaxel, although the long-term benefit is uncertain. In addition, there was no trial data directly comparing pembrolizumab plus chemotherapy with atezolizumab plus chemotherapy, another targeted treatment which NICE already recommends.

Therefore, the cost-effectiveness estimates are higher than NICE normally considers an acceptable use of NHS resources. 

The committee would like to see more information from the company about the comparison between pembrolizumab plus chemotherapy with atezolizumab plus chemotherapy.

Helen Knight, programme director in the NICE Centre for Health Technology Evaluation, said: “I know that today’s announcement will be disappointing for people with this type of breast cancer, as well as for their families and carers. Advanced triple negative breast cancer has a significant negative impact on quality of life. It can be more aggressive than other types of breast cancer and accounts for a quarter of all deaths from breast cancer despite accounting for only 1 in 5 cases.

“NICE already recommends atezolizumab with chemotherapy, the only other targeted treatment for this type of breast cancer, and another treatment is in our pipeline to be looked at. However, there are people who aren’t eligible for atezolizumab combination who could be eligible for pembrolizumab with chemotherapy

“We are committed to working with the company to try to resolve the issues identified by the committee. In the meantime, I would encourage anyone with an interest in this topic to give us their feedback on this draft guidance.” 

Given by injection every 2 weeks, pembrolizumab (also called Keytruda and made by Merck Sharp and Dohme) is a type of immunotherapy that specifically targets triple negative breast cancer. It works by blocking the activity of a protein known as PD-L1 which is produced in larger amounts on cancerous cells than normal cells. By blocking PD-L1 it helps the person’s own immune cells to attack the cancer.

Pembrolizumab is licensed for use with chemotherapy in adults with triple negative breast cancer who have not had chemotherapy for metastatic disease and where surgery to remove the tumour is not possible.

Around 600 people in England with advanced triple negative breast cancer would have been eligible for treatment with the pembrolizumab combination.

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