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HIMALAYA Trial OS Data

Understanding IMFINZI treatment for your patients with unresectable hepatocellular carcinoma (uHCC)

IMFINZI (durvalumab for injection) in combination with tremelimumab is indicated for the first-line treatment of adult patients with unresectable hepatocellular carcinoma (uHCC) who require systemic therapy.1

Single dose IMJUDO + regular interval IMFINZI: the only anti-CTLA-4 + anti-PD-L1 combination indicated in unresectable hepatocellular carcinoma (uHCC) in the first-line setting1-3*

The recommended dose of IMJUDO is 300 mg as a single dose, followed by IMFINZI 1500 mg at Day 1 of Cycle 1. Continue IMFINZI 1500 mg as a single agent every 4 weeks.

Be IN the know with IMFINZI’s + IMJUDO’s HIMALAYA OS data

HIMALAYA:
Primary OS analysis

(full analysis set; median duration of follow-up 33.2 [31.7-34.5] months IMFINZI + IMJUDO, 32.6 [31.6-33.7] months IMFINZI, and 32.2 [30.4-33.7] months sorafenib)1,2†

Adapted from the IMFINZI and IMJUDO Product Monographs and Abou-Alfa GK, et al.

IMFINZI + IMJUDO reduced the risk of death by 24% vs. sorafenib

(HR=0.76; 95% CI, 0.64-0.90; p=0.0013); event rate: 262/393 vs. 293/389 sorafenib.

Progression-Free Survival (PFS):
HR=0.89; 95% CI, 0.76-1.04
Event rate: 335/393 (IMJUDO + IMFINZI) vs. 327/389 (sorafenib)

† HIMALAYA was a randomized, open-label, multicentre, international phase III trial in patients with confirmed uHCC who did not receive prior systemic treatment. The study included patients with BCLC Stage C or B (not eligible for locoregional therapy), Child-Pugh Score Class A, and ECOG performance status of 0 or 1. Patients were randomized 1:1:1 to receive IMFINZI 1500 mg (IV) Q4W plus a single priming dose of IMJUDO 300 mg (IV) (n=393), IMFINZI 1500 mg (IV) Q4W alone (n=389) or sorafenib (oral) 400 mg BID (n=389). Treatment continued until disease progression or unacceptable toxicity. The primary objective was to assess the overall survival (OS) between the IMFINZI + IMJUDO arm versus the sorafenib arm for superiority.

IMFINZI + IMJUDO Mechanism of Action 

Tremelimumab + durvalumab enhances antitumour T-cell activation and proliferation, helping to enhance antitumour immunity1,2†

Anti-CTLA-4 therapy tremelimumab has been shown to induce
T-cell activation and expansion2

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Watch the IMFINZI and IMJUDO mechanisms of action

References:

  1. IMFINZI Product Monograph. AstraZeneca Canada Inc. February 20, 2026.
  2. IMJUDO Product Monograph. AstraZeneca Canada Inc. June 20, 2025.
  3. Data on File, AstraZeneca Canada Inc. (only CTLA4 PD-L1). October 29, 2024.
  4. Abou-Alfa GK, Lau G, Kudo M, et al. Tremelimumab plus durvalumab in unresectable hepatocellular carcinoma. NEJM Evidence. 2022;1(8) (including Supplementary Appendix and Protocol). doi:10.1056/ EVIDoa2100070.

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