Durvalumab in combination with tremelimumab [DUR6]

For first-line systemic treatment of adult patients with locally advanced or metastatic and/or unresectable hepatocellular carcinoma where the following criteria have been met:

1. This application is being made by and the first cycle of systemic anti-cancer therapy with durvalumab in combination with tremelimumab will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
2. The patient has a diagnosis of hepatocellular carcinoma and that one of the following applies to the patient (please tick appropriate box below as to which option applies):

• either option 1 applies in which case the patient has a confirmed histological diagnosis of hepatocellular carcinoma (HCC)
• or option 2 applies in which case a biopsy is deemed to be very high risk or technically not feasible in the patient and both the criteria a and b below are also both met: a: the decision not to biopsy has been made and documented by a specialist HCC multi-disciplinary team meeting and b: the tumour meets the non-invasive diagnostic criteria of HCC as set out below. It is expected that option 2 will only apply in exceptional circumstances. Please mark below which of these 2 clinical scenarios applies to this patient: Option 1: the patient has a confirmed histological diagnosis of hepatocellular carcinoma or Option 2: the patient cannot be biopsied on account of high risk or technical lack of feasibility and the above criteria for option 2 all apply. EASL-EORTC Clinical Practice Guidelines: Management, Journal of Hepatology 2012 vol 56 p908-943. Non-invasive criteria can only be applied to cirrhotic patients and are based on imaging techniques obtained by 4-phase multidetector CT scan or dynamic contrast-enhanced MRI. Diagnosis should be based on the identification of the typical hallmark of HCC (hypervascular in the arterial phase with washout in the portal venous or delayed phases). While one imaging technique is required for nodules beyond 1cm in diameter, a more conservative approach with 2 techniques is recommended in suboptimal settings.

3. The patient has metastatic or locally advanced disease that is ineligible for or has failed surgical or loco-regional therapies.
4. The patient has Child-Pugh A liver function.
5. The patient has not received previous systemic therapy for his/her hepatocellular carcinoma. Note: previous systemic treatment with sorafenib or lenvatinib or regorafenib or any immunotherapy or any systemic chemotherapy is not allowed.
6. The patient has an ECOG performance status score of 0 or 1. 7.Treatment with durvalumab after its initial single dose in combination with tremelimumab will continue until loss of clinical benefit or unacceptable toxicity or withdrawal of patient consent, whichever occurs first.
7. The patient has no symptomatically active brain metastases or leptomeningeal metastases.
8. The patient has not received prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody.
9. Durvalumab will be given intravenously at a dose of 1500 mg every 4 weeks.
10. When a treatment break of more than 12 weeks beyond the expected 4-weekly cycle length is needed, I will complete a treatment break form to restart treatment.
11. On discontinuation of the combination of durvalumab on account of loss of clinical benefit or treatment intolerance and if the patient is fit for further systemic therapy, the next line of treatment would be a choice of either sorafenib or lenvatinib.
12. Durvalumab and tremelmumab will otherwise be used as set out in their respective Summary of Product Characteristics (SPCs).

CDF funded From: 29 July 2025

Additional information

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CDF Managed Access: No

NICE Technology Appraisal: NA (NA)

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The data on this page was produced using version 1.370 of the CDF list, downloaded from NHS England’s website on 31 July 2025 at 11:00.

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