Unresectable Hepatocellular Carcinoma: Imfinzi Plus Imjudo Combination Therapy

FDA Approval of Dual Immunotherapy

On October 24, 2022, AstraZeneca announced the regulatory approval of Imfinzi (durvalumab, anti-PD-L1 antibody) in combination with Imjudo (tremelimumab, anti-CTLA-4 antibody) for the treatment of unresectable hepatocellular carcinoma (HCC) in the United States.

Clinical Context and Unmet Medical Need

Hepatocellular carcinoma represents the most prevalent histological type of liver cancer, accounting for approximately 75% of primary liver malignancies. At diagnosis, approximately 50% of HCC patients present with advanced-stage disease. Among these patients, 80-90% exhibit concurrent hepatic cirrhosis as a comorbid condition. The therapeutic landscape for HCC has historically been limited, with immunotherapy options remaining restricted in scope and efficacy.

HIMALAYA Phase III Clinical Trial Results

The approval was substantiated by data from the HIMALAYA Phase III randomized controlled trial, which enrolled 1,324 treatment-naïve patients with unresectable HCC who were ineligible for locoregional therapy. Patients were randomized into three treatment arms:

• Imfinzi monotherapy (1,500 mg)
• Imfinzi (1,500 mg) plus Imjudo (300 mg) administered every four weeks
• Sorafenib control arm

Key Efficacy and Safety Outcomes

The HIMALAYA trial demonstrated significant clinical benefit with the combination regimen:

Mortality Reduction: The Imfinzi plus Imjudo arm demonstrated a 22% reduction in death risk compared to sorafenib control.

Overall Survival: The estimated 3-year overall survival rates were:

• Imfinzi plus Imjudo: 30%
• Sorafenib: 20%

Clinical Significance

According to Dave Fredrickson, AstraZeneca executive, the approval of Imjudo expands therapeutic options for patients with unresectable HCC in the United States by providing access to CTLA-4 inhibition. This dual-checkpoint immunotherapy approach enhances anti-tumor immune response through complementary mechanisms targeting both PD-L1 and CTLA-4 pathways.

Data Source

Information adapted from: https://www.astrazeneca.com/media-centre/press-releases/2022/imfinzi-and-imjudo-approved-in-advanced-liver-cancer.html

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