Pembrolizumab monotherapy [PEMB25]

For the treatment of patients with ENDOMETRIAL carcinoma exhibiting microsatellite instability (MSI-H) or deficient mismatch repair (dMMR) and who have progressive disease during or following prior platinum-containing therapy given in any setting for advanced or recurrent or metastatic disease and who are not candidates for potentially curative surgery or radiotherapy or chemoradiotherapy 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 monotherapy 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 endometrial carcinoma. Note: patients with endometrial sarcoma of any kind or with carcinosarcoma (Mixed Mullerian tumour) are NOT eligible for pembrolizumab monotherapy.
  4. The patient’s endometrial carcinoma has documented presence of microsatellite instability (MSI-H) or deficient mismatch repair (dMMR) confirmed by validated testing.
  5. The patient has advanced or recurrent or metastatic endometrial carcinoma and is not a candidate for any potentially curative treatment with surgery or radiotherapy or chemoradiotherapy.
  6. The patient has received at least 1 prior platinum-containing chemotherapy given in any setting whether this was as neoadjuvant chemotherapy or as adjuvant therapy or as chemoradiotherapy or for recurrent disease or for metastatic disease or for more than one of these settings.
  7. The patient has progressive disease during or following the most recent platinum-containing chemotherapy.
  8. Pembrolizumab will be given as monotherapy. Note: pembrolizumab is not to be used with any other systemic anti-cancer treatments in this indication.
  9. The patient has NOT received any prior antibody treatment which targets PD-1 or PD-L1 or PD-L2 or CD137 or OX40 or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4).
  10. The patient will be treated with a fixed dose of pembrolizumab of either 200mg every 3 weeks or 400mg every 6 weeks. Note: NHS England recommends the use of 6-weekly pembrolizumab whenever appropriate.
  11. Treatment with pembrolizumab will be stopped at whichever of the following events occurs first: disease progression or loss of clinical benefit 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).
  12. The patient has an ECOG performance status (PS) of 0 or 1. Note: NHS England does not fund this treatment in patients of ECOG PS 2.
  13. The patient has no symptomatically active brain metastases or leptomeningeal metastases.
  14. A formal medical review as to how pembrolizumab is being tolerated and whether treatment should continue or not will be scheduled to occur at least by the end of the second month of treatment.
  15. 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.
  16. Pembrolizumab will be otherwise used as set out in its Summary of Product Characteristics (SPC).

[NHS funded]{.badge .rounded-pill .bg-success} From: 19 December 2023

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CDF Managed Access: NA

NICE Technology Appraisal: TA914 (20 September 2023)

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