Pembrolizumab in combination with or nab-paclitaxel [PEMB18]

The treatment of previously untreated locally advanced unresectable or metastatic triple negative breast cancer patients with PD-L1 expression test results of immune cell (IC) <1% and a combined positive score (CPS) of 10 or more where the following criteria have been met:

1. This application is being made by and the first cycle of systemic anti-cancer therapy will be prescribed by a consultant, or internally accredited oncology specialty trainee, specifically trained and assessed in the use of systemic anti- cancer therapy.
2. The patient has a histologically- or cytologically-confirmed diagnosis of breast cancer.
3. The patient has either locally advanced unresectable or metastatic breast cancer.
4. The patient’s breast cancer has had receptor analysis performed and this is negative for all of the following: the HER2 receptor, oestrogen receptor and progesterone receptor i.e. the patient has triple negative disease.
5. The patient’s tumour has been tested by an approved and validated test for PD-L1 expression as measured by the immune cell (IC) test and the result is <1%.

Note

Note: if the PD-L1 immune cell (IC) result is 1% or more, the patient must not be treated with pembrolizumab and should be treated with atezolizumab.

6. The patient’s tumour has been tested by an approved and validated test for PD-L1 expression as measured by the combined positive score (CPS) test and the result is 10 or more. Please document the actual PD-L1 expression below with the CPS result: PD-L1 expression with the CPS test: _________ Note two separate tests for PD-L1 expression are required as the manufacturer of pembrolizumab, MSD, only sought a recommendation from NICE for patients who were ineligible for atezolizumab and had a PD-L1 expression test result as measured by the combined positive score (CPS) test of 10 or more.
7. The patient has had no prior systemic therapy for the locally advanced unresectable or metastatic disease indication.
8. Either the patient has never had any prior treatment with anti-PD-L1/PD-1 therapy for the breast cancer or the only previous anti-PD-1/PD-L1 treatment that the patient has received was with prior neoadjuvant and adjuvant therapy and there was no disease progression during such treatment and for at least 12 months after completion of anti-PD-1/PD-L1 therapy. Please mark below which of these clinical scenarios applies to this patient:

• the patient has never had any prior treatment with anti-PD-1/PD-L1 therapy for the breast cancer or in
• the only previous anti-PD-1/PD-L1 treatment that the patient has received was prior neoadjuvant and adjuvant therapy and there was no disease progression during such treatment and for at least 12 months after completion of anti- PD-1/PD-L1 therapy Please document in the box below the time gap in months between completion of the previous neoadjuvant and adjuvant anti-PD-1/PD-L1immunotherapy and the first diagnosis of disease relapse. If the patient has never had such immunotherapy, please type ‘n/a’. Time gap in months after the completion of previous neoadjuvant and adjuvant anti-PD-1/PD-L1 immunotherapy and the first diagnosis of disease relapse: _________

9. The patient will be treated with a fixed dose pembrolizumab schedule as shown below • If using the subcutaneous formulation – 395mg given every 3 weeks or 790mg given every 6 weeks • If using the intravenous formulation – 200mg given every 3 weeks or 400mg given every 6 weeks

Note

Note: Pembrolizumab may be continued as a single agent if paclitaxel/nab-paclitaxel has to be discontinued due to toxicity.

10. Treatment with pembrolizumab will be stopped at whichever of the following events occurs first: disease progression or unacceptable toxicity or withdrawal of patient consent or after 2 years of treatment (or after 35 x 3-weekly cycles or its equivalent if 6-weekly pembrolizumab is used).
11. The patient will be treated with either paclitaxel at an initial dose of 90mg/m² on days 1, 8 and 15 of a 28 day treatment cycle or nab-paclitaxel at an initial dose of 100mg/m² on days 1, 8 and 15 of a 28 day treatment cycle, both of these chemotherapies having no maximum number of cycles as long as there is no disease progression, unacceptable toxicity or withdrawal of patient consent.

Note

Note: this dose and schedule of nab-paclitaxel is not currently the licensed dose and schedule in metastatic breast cancer. Note: pembrolizumab is only recommended by NICE in combination with paclitaxel or nab-paclitaxel. The use of pembrolizumab in combination with carboplatin and gemcitabine (which was an option in the registration trial) is not funded as the company did not make a case to NICE for the clinical and cost effectiveness for pembrolizumab in combination with carboplatin and gemcitabine.

12. The patient has an ECOG performance status (PS) of 0 or 1.
13. The patient has no symptomatically active brain metastases or leptomeningeal metastases.
14. Where a treatment break of more than 12 weeks beyond the expected 3 or 6-weekly cycle length is needed, the prescribing clinician will complete a treatment break approval form to restart treatment, which MUST be approved before treatment with pembrolizumab is recommenced.
15. Pembrolizumab and paclitaxel/nab-paclitaxel will be otherwise used as set out in their respective Summary of Product Characteristics (SPCs).

NHS funded From: 27 September 2022

Additional information

Form version: 1.3 paclitaxel

CDF Managed Access: NA

NICE Technology Appraisal: TA801 (29 June 2022)

Current Form Version

Note

The data on this page was produced using version 1.399 of the CDF list, downloaded from NHS England’s website on 21 May 2026 at 18:00.

If NHS England has published a new version of the CDF List but this site has not yet accessed that, this form may be out of date. Additionally, if any update has occurred without NHS England noting it as a change, this page will be out of date.