NICE (UK) recommends pembrolizumab to treat triple-negative, locally recurrent unresectable or metastatic breast cancer.

It is recommended only if: i. the tumours express PDL1 with a combined positive score (CPS) of 10 or more and an immune cell staining (IC) of less than 1%, and ii. the company provides pembrolizumab according to the commercial arrangement.

This recommendation is not intended to affect treatment with pembrolizumab plus chemotherapy that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.

Why the committee made these recommendations: Treatment for untreated, triple-negative, locally recurrent unresectable or metastatic breast cancer includes chemotherapy such as docetaxel or paclitaxel, or atezolizumab plus nab-paclitaxel immunotherapy (from now, atezolizumab combination). There is an unmet need for alternative treatments for people who cannot have atezolizumab combination. Pembrolizumab plus paclitaxel or nab-paclitaxel (from now, pembrolizumab combination) is another immunotherapy that could be used. The company proposed pembrolizumab combination for people whose tumours express PD-L1 with a CPS of 10 or more and an IC of less than 1%. This is narrower than the marketing authorisation and makes pembrolizumab combination an alternative treatment for people who cannot have atezolizumab combination. Clinical trial evidence shows that, compared with paclitaxel, pembrolizumab combination increases how long people have before their cancer gets worse and how long they live. The cost-effectiveness estimates for pembrolizumab combination compared with both paclitaxel and docetaxel are within what NICE usually considers an acceptable use of NHS resources. Therefore, it is recommended.