Eligible Australians living with advanced unresectable hepatocellular carcinoma (HCC)1, the most common type of liver cancer, can access the first dual immunotherapy combination option to be made available on the Pharmaceutical Benefits Scheme (PBS) from 1 November 2025.
The reimbursement is for AstraZeneca’s IMFINZI® (durvalumab) in combination with a single dose of IMJUDO® (tremelimumab), followed by IMFINZI® monotherapy, for the treatment of adult patients with unresectable HCC (uHCC) who have not received prior treatment with a PD1/PD-L1 inhibitor2. This treatment is also known as the STRIDE regimen (single tremelimumab regular interval durvalumab).
- In Australia, liver cancer is one of the fastest-growing causes of cancer-related death, with new diagnoses and deaths rising over the past decade3. The disease burden is disproportionately high among some communities, including Aboriginal and Torres Strait Islander peoples and those born in regions with higher hepatitis prevalence (including Asia and the Pacific Islands)4.
- HCC is the most common type of primary liver cancer, accounting for approximately 75 per cent of all liver cancers4. Many people are diagnosed at an advanced stage, when surgery is no longer possible. Risk factors include chronic hepatitis B or C, alcohol-related liver disease, non-alcoholic fatty liver disease and cirrhosis5.
- Treatment options for people with advanced-stage HCC, who face an estimated 5-year survival rate of less than 10 per cent6, have been limited.
- As IV-administered immunotherapies working in combination, IMFINZI® helps the immune system to recognise and kill tumour cells that are trying to hide7, while IMJUDO® boosts the immune system’s T cells (T lymphocytes) so they can fight the cancer more effectively8.
- The combination treatment of IMFINZI® with IMJUDO® enables the body’s immune system to recognise and kill cancer cells and provides patients with uHCC with a newly reimbursed option for initial treatment.
Ben McDonald, Country President of AstraZeneca Australia and New Zealand, which has delivered innovative cancer medicines to Australian patients for more than 40 years, said: “We welcome the Government’s decision to list on the PBS the dual immunotherapy combination of IMJUDO® and IMFINZI®, which around 900 Australians living with the most common form of advanced liver cancer may now be able to access.
“We will continue to advocate for earlier, faster, fairer access to diagnosis and therapies for the benefit of Australians living with liver cancer.”
Professor Jacob George, a liver specialist and research scientist with 25 years’ experience leading clinical research in liver diseases, said: “The PBS listing of this combination immunotherapy treatment is a welcome alternative for advanced HCC patients.”
Professor Stuart Roberts, Head of Hepatology at Alfred Health, said: “This listing provides another option for Australians living with advanced HCC, bringing Australia in line with other countries where this combination therapy is already available.”
ABOUT IMFINZI7 and IMJUDO8
Indication: IMFINZI® in combination with IMJUDO® for the treatment of adult patients with unresectable hepatocellular carcinoma who have not received prior treatment with a PD-1/PD-L1 inhibitor.
Precautions: Patients should inform their doctor if they have any of the following medical conditions: immune system problems such as Crohn’s disease, ulcerative colitis or lupus; have had an organ transplant; have lung or breathing problems or have liver problems. Patients should inform their doctor if they are pregnant or intend to become pregnant, are breastfeeding or intending to breastfeed, or if under the age of 18 years.
Interactions: Patients should inform their doctor if they are taking any other medicines, including any medicines, vitamins, or supplements without a prescription from a pharmacy, supermarket or health food shop.
Side effects: Common side effects of taking IMFINZI in combination with IMJUDO include an underactive thyroid gland that can cause tiredness or weight gain; stomach pain; diarrhoea; abnormal pancreas function test; swelling of the legs; fever; abnormal liver function tests; cough; and skin rash or itchiness.
Common side effects of taking IMFINZI monotherapy include: cough, diarrhoea, stomach pain, skin rash or itchiness, fever, swelling of the legs, upper respiratory tract infection, underactive thyroid gland that can cause tiredness or weight gain (hypothyroidism), overactive thyroid gland which may cause many different symptoms including weight loss, hand tremors, rapid or irregular heartbeat.
More information can be found in the IMFINZI® Consumer Medicine Information here: https://rss.medsinfo.com.au/ap/cmi.cfm?product=apcimfip10823
More information can be found in the IMJUDO® Consumer Medicine Information here:
https://rss.medsinfo.com.au/ap/cmi.cfm?product=apcimjud10825
▼ This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at www.tga.gov.au/reporting-problems
PBS Information2:
Authority required (STREAMLINED): Refer to PBS Schedule for full information.
- ENDS-
Professor Jacob George has been involved in clinical trials sponsored by AstraZeneca; and has served on advisory boards for which compensation was received. In relation to this AstraZeneca media announcement, no compensation was provided to Professor George, and the opinions expressed are their own. Professor George has been briefed by AstraZeneca on the approved use of this product.
Professor Stuart Roberts has been involved in clinical trials sponsored by AstraZeneca; and has served on advisory boards for which compensation was received. In relation to this AstraZeneca media announcement, no compensation was provided to Professor Roberts, and the opinions expressed are their own. Professor Roberts has been briefed by AstraZeneca on the approved use of this product.
Media Contacts
AstraZeneca Australia
IMFINZI® (durvalumab) and IMJUDO® (tremelimumab) are registered trademarks of AstraZeneca. ABN 54 009 682 311. 66 Talavera Road, Macquarie Park, NSW 2113. www.astrazeneca.com.au
For Medical Information enquiries or to report an adverse event or product quality complaint: Telephone 1800 805 342 or via https://contactazmedical.astrazeneca.com or email Medical Information enquiries to medinfo.australia@astrazeneca.com
Notes to editors
Liver cancer in Australia
Liver cancer is among Australia’s fastest rising cancers in both incidence and mortality.9 Hepatocellular carcinoma (HCC) is the most common type of primary liver cancer. HCCs develop from hepatocytes, the main cells found in the liver.12
In 2024 it was estimated that more than 3,200 Australians were diagnosed with liver cancer and ~2,600 lost their lives11, accounting for approximately 5% of all deaths from cancer. Liver cancer impacts approximately three times more men than women, with 70% of cases occurring in people over the age of 60.12
Risk factors that can increase the risk of developing liver cancer include:
· Chronic hepatitis B or C;
· Alcohol-related liver disease
· Non-alcoholic fatty liver disease;
· Cirrhosis (significant scarring of liver tissue).
In Australia the greatest burden of HCC is among Aboriginal and/or Torres Strait Islander people who were 2.5 times more likely than non-Indigenous Australians to develop, and 1.4 times more likely to die from this disease.10
About IMFINZI®7
Containing the active ingredient durvalumab, IMFINZI® is a monoclonal antibody, a type of protein. It is a type of immunotherapy and belongs to a group of medicines called immune checkpoint inhibitors. It works with the patient’s immune system to destroy cancer cells.
IMFINZI® is prescribed and administered to patients in a hospital or clinic via infusion.
About IMJUDO®8
Containing the active ingredient tremelimumab, IMJUDO® is a monoclonal antibody, a type of protein. It is a type of immunotherapy and belongs to a group of medicines called immune checkpoint inhibitors. It works with the patient’s immune system to help fight cancer cells.
IMJUDO® is prescribed and administered to patients in a hospital or clinic via infusion.
About AstraZeneca
AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas – Oncology; Cardiovascular, Renal & Metabolism; and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in more than 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit www.astrazeneca.com.au
References
1. https://liver.org.au/your-liver/liver-cancer/hcc/ Accessed October 2025
2. https://www.tga.gov.au/resources/prescription-medicines-registrations/imfinzi-astrazeneca-pty-ltd-4 Accessed October 2025
3. https://www.cancer.org.au/about-us/policy-and-advocacy/early-detection/liver-cancer Accessed October 2025
4. https://www.aihw.gov.au/reports/cancer/cancer-data-in-australia/contents/stage Accessed October 2025
5. https://www.cancer.org.au/cancer-information/types-of-cancer/liver-cancer Accessed October 2025
6. https://www.sciencedirect.com/science/article/pii/S0168827825002260 Accessed October 2025
7. IMFINZI Consumer Medicine Information. https://rss.medsinfo.com.au/ap/cmi.cfm?product=apcimfip10825 Accessed October 2025
8. IMJUDO Consumer Medicine Information https://rss.medsinfo.com.au/ap/cmi.cfm?product=apcimjud10825 Accessed October 2025
9. https://www.cancer.org.au/about-us/policy-and-advocacy/early-detection/liver-cancer Accessed October 2025
10. https://www.mja.com.au/journal/2024/221/5/overcoming-disparities-hepatocellular-carcinoma-outcomes-first-nations Accessed October 2025
11. https://www.canceraustralia.gov.au/cancer-types/liver-cancer/liver-cancer-australia-statistics# Accessed October 2025
12. https://www.cancercouncil.com.au/news/5-things-to-know-about-liver-cancer/ Accessed October 2025
AstraZeneca Pty. Ltd. ABN 54 009 682 311. 66 Talavera Road, Macquarie Park, NSW 2113. www.astrazeneca.com.au For Medical Information enquiries or to report an adverse event or product quality complaint: Telephone 1800 805 342 or via https://contactazmedical.astrazeneca.com | AU-23821 October 2025