Published

May 11, 2025

Pembrolizumab in combination with lenvatinib [PEMB23]

For the treatment of patients with endometrial carcinoma who have progressive disease during or following prior platinum-containing therapy given 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 in combination with lenvatinib 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 plus lenvatinib.
  4. The mismatch repair status of the endometrial carcinoma if known at present:
  • mismatch repair deficient
  • mismatch repair proficient
  • mismatch repair status not known at present
  1. 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.
  2. 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.
  3. The patient has progressive disease during or following the most recent platinum-containing chemotherapy.
  4. Pembrolizumab will be given in combination with lenvatinib. Note: neither pembrolizumab nor lenvatinib are to be used with any other systemic anti-cancer treatments in this indication.
  5. The patient has not received any prior vascular endothelial receptor-targeted agent unless the patient received lenvatinib via the Eisai company early access scheme and all other treatment criteria on this form are fulfilled. in
  6. The starting dose for lenvatinib in this indication is 20mg daily. Note: the daily dosages of lenvatinib are indication-specific and hence care should be taken for the correct lenvatinib dose to be used as there are different licensed daily dosages in other cancers.
  7. 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) unless the patient has received pembrolizumab via the MSD company early access scheme and all other treatment criteria on this form are fulfilled.
  8. Lenvatinib 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. Note: lenvatinib can be continued in responding patients after pembrolizumab has been discontinued (see criterion 13).
  9. 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.
  10. 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). Note: provided that the above maximum treatment duration of pembrolizumab has not been and will not be exceeded, pembrolizumab can be continued in responding patients if treatment with lenvatinib has to be stopped.
  11. The patient has an ECOG performance status (PS) of 0 or 1. Note: NHS England does not fund this combination in patients of ECOG PS 2.
  12. The patient has no symptomatically active brain metastases or leptomeningeal metastases.
  13. A formal medical review as to how pembrolizumab and lenvatinib are being tolerated and whether treatment with this combination should continue or not will be scheduled to occur at least by the end of the first 6 weeks of treatment.
  14. 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.
  15. Pembrolizumab and lenvatinib will be otherwise used as set out in their respective Summary of Product Characteristics (SPCs).

NHS funded From: 19 September 2023

Form version:

CDF Managed Access: NA

NICE Technology Appraisal: TA904 (21 June 2023)

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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