Published

May 11, 2025

Pembrolizumab [PEMB21]

Pembrolizumab in combination with chemotherapy as neoadjuvant treatment and then continued as adjuvant monotherapy after definitive surgery for patients with previously untreated locally advanced or early stage triple negative breast cancer at high risk of recurrence where the following criteria have been met:

  1. This application is being made by and the first cycle of neoadjuvant systemic anti-cancer therapy with pembrolizumab in combination with carboplatin and paclitaxel will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
  2. The prescribing clinician is fully aware of the management of and the treatment modifications that may be required for immune-related adverse reactions due to anti-PD-L1 treatments including pneumonitis, colitis, nephritis, endocrinopathies, hepatitis and skin toxicity.
  3. The patient has a histologically- or cytologically-confirmed diagnosis of breast cancer.
  4. The patient’s breast cancer has had receptor analysis performed and this is negative for all the following: the HER2 receptor, oestrogen receptor and progesterone receptor i.e. the patient has triple negative disease.
  5. The patient has newly diagnosed and previously untreated breast cancer.
  6. There is no clinical/radiological evidence to suggest that the patient has metastatic disease ie the patient has M0 disease.
  7. The patient is defined as being at high risk of recurrence as defined by having T1c N1-2 or T2-4 N0-2 disease. Please indicate below the staging of the breast cancer in this patient:
  • T1c N1-2 disease or
  • T2 N0 disease or
  • T2 N1-2 disease or
  • T3 N0 disease or
  • T3 N1-2 disease or
  • T4 N0 disease or
  • T4 N1-2 disease
  1. The intent of the neoadjuvant part of therapy is to treat this patient with the sequential combinations of both carboplatin plus paclitaxel and then an anthracycline plus cyclophosphamide in combination with pembrolizumab.
  2. The patient will commence the first phase of neoadjuvant treatment with pembrolizumab in combination with carboplatin (AUC 5 mg/ml/min if given 3-weekly) and paclitaxel and the intent is to give 4 cycles of chemotherapy with this pembrolizumab, carboplatin and paclitaxel regimen (i.e. a planned 12 weeks of treatment).
  3. After completing the first phase of neoadjuvant chemotherapy, the intent in the second phase of neoadjuvant treatment is to treat with pembrolizumab in combination with an anthracycline and cyclophosphamide for 4 cycles (i.e. a planned 12 weeks of treatment).
  4. During the neoadjuvant phases of treatment the patient will be treated with a fixed dose of pembrolizumab of either 400mg every 6 weeks or 200mg every 3 weeks such that the patient will receive a maximum of 4 cycles of 6- weekly pembrolizumab or 8 cycles of its 3-weekly equivalent ie there is a maximum of a 24 week pembrolizumab treatment duration in the neoadjuvant phases of treatment.
  5. If the patient has progressive disease despite neoadjuvant treatment and/or does not have definitive surgery then the patient will NOT proceed to adjuvant pembrolizumab therapy.
  6. If the patient proceeds to adjuvant pembrolizumab after definitive surgery the intent is to commence adjuvant pembrolizumab within 2 months of that surgery.
  7. During the adjuvant phase of treatment the patient will be treated with a fixed dose of pembrolizumab monotherapy of either 400mg every 6 weeks or 200mg every 3 weeks such that the patient will receive a maximum of 5 cycles of 6-weekly pembrolizumab or 9 cycles of 3-weekly pembrolizumab. Note: NHS England expects the 6-weekly schedule of administration of pembrolizumab to be used at least in the adjuvant phase of treatment unless there are clear clinical reasons for preferring the 3-weekly schedule.
  8. Treatment with pembrolizumab will be stopped at whichever of the following events occurs first: disease progression during neoadjuvant chemotherapy such that all neoadjuvant chemotherapy is discontinued or disease progression at the end of neoadjuvant chemotherapy or unacceptable toxicity or withdrawal of patient consent or after a maximum total of 9 x 6-weekly cycles of pembrolizumab treatment in both neoadjuvant and adjuvant phases of treatment (or after a maximum total of 17 x 3-weekly cycles).
  9. The patient has not received prior treatment with an anti-PD-1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody unless the patient has received neoadjuvant/adjuvant pembrolizumab in a company early access scheme for this same indication and all the other treatment criteria set out on this form are fulfilled. Please mark below which option applies to this patient:
  • no previous check point inhibitor therapy for this neoadjuvant/adjuvant breast cancer indication or
  • previous pembrolizumab as part of neoadjuvant/adjuvant therapy in a company early access scheme and all the other treatment criteria on this form are fulfilled
  1. The patient has an ECOG performance status (PS) of 0 or 1.
  2. A formal medical review as to how pembrolizumab and neoadjuvant chemotherapy are being tolerated and whether neoadjuvant chemotherapy should continue or not will be scheduled to occur at least by the end of the first 6 weeks of treatment.
  3. When a treatment break of more than 12 weeks beyond the expected 3 or 6 weekly cycle length is needed, a treatment break approval form will be completed to restart treatment.
  4. Pembrolizumab and the neoadjuvant cytotoxic chemotherapies will be otherwise used as set out in their respective Summary of Product Characteristics (SPCs).

NHS funded From: 14 March 2023

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CDF Managed Access: NA

NICE Technology Appraisal: TA851 (14 December 2022)

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