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Pembrolizumab plus chemotherapy for untreated, triple-negative, locally recurrent unresectable or metastatic breast cancer

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1 Recommendations

1.1 Pembrolizumab plus chemotherapy (paclitaxel or nab-paclitaxel) is not recommended, within its marketing authorisation, for treating triple-negative, locally recurrent unresectable or metastatic breast cancer in adults whose tumours express PD‑L1 with a combined positive score of 10 or more and who have not had chemotherapy for metastatic disease.

1.2 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

Current treatment for untreated, triple-negative, locally recurrent unresectable or metastatic breast cancer includes chemotherapy such as docetaxel, paclitaxel, or the immunotherapy atezolizumab plus nab-paclitaxel (from now, atezolizumab combination). Pembrolizumab plus paclitaxel or nab-paclitaxel (from now, pembrolizumab combination) is another immunotherapy that could be used.

Clinical trial evidence shows that pembrolizumab combination increases how long people have before their cancer gets worse and how long they live compared with paclitaxel. However, the long-term benefit is uncertain. Pembrolizumab combination and atezolizumab combination have only been compared indirectly, so how their effectiveness compares is uncertain.

The company did not make a robust case for applying end of life criteria. This means the cost-effectiveness estimates are higher than what NICE usually considers an acceptable use of NHS resources. Therefore, it is not recommended.