Durvalumab And Tremelimumab
First-line treatment of patients with advanced (unresectable) Barcelona Clinic Liver Cancer (BCLC) Stage B or Stage C hepatocellular carcinoma (HCC).
Decision on record
- Meeting May 2025 Recommended Advanced Stage B/C hepatocellular carcinoma (STRIDE regimen)
Access path
- May 2025Recommended · restricted
vs atezolizumab plus bevacizumab
- PBS listing · Authority Required
From the public summary
7.1 The PBAC recommended the Section 100 (Efficient Funding of Chemotherapy), Authority Required (Streamlined) listing of durvalumab and single dose tremelimumab (a.k.a. STRIDE) for the treatment of patients with advanced (unresectable) Barcelona Clinic Liver Cancer (BCLC) Stage B or Stage C hepatocellular carcinoma (HCC).PSD · May 2025
• A single dose of tremelimumab 300 mg + durvalumab 1,500 mg given at the start of Cycle 1 + ongoing durvalumab at a dose of 1,500 mg once every four weeks for a duration of 11.6 months (based on the mean treatment duration in HIMALAYA over 5 years' follow-up); andPSD · May 2025
6.33 The submission presented a CMA comparing STRIDE to atezo + b based on the HIMALAYA and IMBRAVE150 trials. The reasonableness of this approach is contingent on the assumption that STRIDE is at least as effective and safe as atezo + b.PSD · May 2025
6.34 The components and assumptions for the CMA are summarised in Table 9. 17 OFFICIALPSD · May 2025
terms of efficacy and safety when compared to atezolizumab plus bevacizumab Source: Table 1-1, pp 29-30 of the submission.PSD · May 2025
6.29 The submission described STRIDE as non-inferior in terms of effectiveness compared with atezo + b and non-inferior in terms of safety compared to atezo + b.PSD · May 2025
6.2 The PBAC noted and welcomed the input from health professionals (3) as well as the Medical Oncology Group of Australia (MOGA) and two consumer organisations (Pancare; Rare Cancers Australia) via the Consumer Comments facility on the PBS website. Comments from health professionals described the poor prognosis of HCC, the lack of effective treatment and limited treatment options.PSD · May 2025
6.3 Pancare noted that liver cancer is one of Australia’s deadliest cancers and that HCC is the most common type and highlighted the limited treatment options for patients if the cancer is advanced or has spread beyond the liver.PSD · May 2025
Cost-effectiveness
Cost-minimisation analysis conducted; no ICER calculated by design.
The submission presented a CMA comparing STRIDE to atezo + b based on the HIMALAYA and IMBRAVE150 trials. PSD · 2025
Decision context
PopulationPatients with advanced (unresectable) BCLC Stage B or Stage C HCC, WHO performance status 0 or 1, not suitable for transarterial chemoembolisation, with Child Pugh class A, untreated with systemic therapy or intolerant to atezolizumab or VEGF inhibitor TKI.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| May 2025 | Recommended · restricted | atezolizumab plus bevacizumab | — | RCT · OS |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| HIMALAYA | Ph 3 | 1,324 | Overall Survival (OS) - Treme 300 mg x1 Dose + Durva 1500 mg vs Sora 400 mg | active not recruiting |
Consumer voice
Health professionals and consumer organisations highlighted the poor prognosis and limited treatment options for hepatocellular carcinoma, emphasizing the significant financial and physical burden of existing treatments on patients' quality of life and ability to work.
some patients do not tolerate existing treatments and experience serious side effects and that additional options for therapy with proven benefit would enable some patients to have long term tumour control and maintain quality of life. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to BCLC Stage B/C, WHO 0–1, Child-Pugh A, ineligible for TACE, versus TGA's broader unresectable HCC label.