Published

May 11, 2025

Pembrolizumab in combination with platinum and fluoropyrimidine-based chemotherapy [PEMB15]

For previously untreated advanced oesophageal carcinoma which expresses PD-L1 with a combined positive score 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 with pembrolizumab in combination with chemotherapy 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-1 or anti-PD-L1 treatments including pneumonitis, colitis, nephritis, endocrinopathies, hepatitis and skin toxicity.
  3. The patient has a histologically- or cytologically-confirmed diagnosis of oesophageal cancer (squamous cell or adenosquamous or adenocarcinoma). Please mark below which histology applies to this patient:
  • squamous cell carcinoma of the oesophagus
  • adenosquamous cell carcinoma of the oesophagus
  • adenocarcinoma of the oesophagus
  1. The patient has locally advanced unresectable or metastatic disease.
  2. An approved and validated test has demonstrated that the tumour has a PD-L1 expression with a combined positive score (CPS) of 10 or more. Please document the actual PD-L1 combined positive score (CPS) below: PD-L1 CPS: _______
  3. The patient has not received any previous systemic therapy for locally advanced unresectable or metastatic disease i.e. that pembrolizumab plus chemotherapy will be 1st line systemic therapy for locally advanced unresectable or metastatic disease. In addition, please mark below whether the patient has/has not previously received any systemic therapy for earlier stage disease:
  • this patient has not received any previous systemic therapy for oesophageal cancer
  • this patient was previously treated with neoadjuvant chemotherapy for oesophageal cancer and underwent surgery and has since had disease progression
  • this patient was previously treated with adjuvant chemotherapy for oesophageal cancer and has since had disease progression
  • this patient was previously treated with concurrent chemo-radiotherapy for oesophageal cancer with or without surgery and has since had disease progression
  1. The patient has not received prior treatment with any antibody which targets PD-1 or PD-L1 or PD-L2 or CD137 or OX40 or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) unless the patient discontinued or completed checkpoint inhibitor immunotherapy as part of adjuvant therapy without disease progression and at least 6 months has elapsed between the date of the last immunotherapy treatment and the date of first diagnosis of relapse with recurrent or metastatic disease. Please mark the appropriate scenario below for this patient: this patient has not received any previous immunotherapy for squamous cell or adenosquamous carcinoma or adenocarcinoma of the oesophagus this patient was previously treated with neoadjuvant platinum-based chemoradiotherapy for squamous cell or adenosquamous or adenocarcinoma of the oesophagus and underwent surgery followed by adjuvant nivolumab (NICE TA 713) and then discontinued or completed treatment with adjuvant nivolumab without disease progression and this was at least 6 months prior to the first diagnosis of relapse. Please document in the box below the time gap in months between completion of previous adjuvant nivolumab immunotherapy and first diagnosis of disease relapse: ________ Note: the mandatory interval between the last date of administration of any prior adjuvant immunotherapy and first relapse is at least 6 months. For patients suffering a first relapse within 6-12 months of previous immunotherapy, clinicians should bear in mind the long elimination half-lives of immunotherapies and make individual assessments of the overall benefit/risk ratio of re-treatment with immunotherapy.
  2. The patient has an ECOG performance status (PS) of 0 or 1 and is fit for platinum and fluoropyrimidine-based chemotherapy in combination with pembrolizumab.
  3. The patient has no symptomatically active brain metastases or leptomeningeal metastases.
  4. Pembrolizumab will be administered at a dose of either 200mg 3-weekly or 400mg 6-weekly, initially in combination with platinum and fluoropyrimidine-based chemotherapy and subsequently as monotherapy.
  5. The chemotherapy used in combination with pembrolizumab will be both platinum and fluoropyrimidine-based. Please mark below which chemotherapy regimen is being used in this patient:
  • oxaliplatin plus capecitabine
  • oxaliplatin plus modified de Gramont regimen
  • cisplatin plus capecitabine
  • cisplatin plus infused 5-fluorouracil
  • another regimen
  1. Pembrolizumab embrolizumab 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 dosing is used). Note: the 2 year stopping rule for pembrolizumab in this indication was a key part of the company submission to NICE of the clinical and cost effectiveness of pembrolizumab in this indication. Note: once pembrolizumab is stopped after 2 years of treatment, it cannot be re-started.
  2. A formal medical review as to how pembrolizumab plus chemotherapy is being tolerated and whether pembrolizumab should continue or not will be scheduled to occur at least by the end of the second 3-weekly cycle of treatment.
  3. When a treatment break of more than 3 months beyond the expected 3- or 6-weekly cycle length is needed, I will complete a treatment break approval form to restart treatment.
  4. Pembrolizumab will otherwise be used as set out in its Summary of Product Characteristics (SPC) with the exception of criterion 12.

NHS funded From: 18 January 2022

Form version:

CDF Managed Access: NA

NICE Technology Appraisal: TA737 (20 October 2021)

Current Form Version

Note

The data on this page was produced using version 1.361 of the CDF list, downloaded from an archive of NHS England’s website on 08 May 2025 at 22:10.

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.

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