AstraZeneca Announces STRIDE Dual Immunotherapy Regimen Demonstrates 22% Reduction in Death Risk for First-Line Unresectable Hepatocellular Carcinoma

Today, AstraZeneca announced that the重磅 PD-L1 inhibitor durvalumab (商品名: Imfinzi) in combination with the anti-CTLA-4 antibody tremelimumab significantly extended overall survival compared to active control in a phase 3 clinical trial for the first-line treatment of patients with unresectable hepatocellular carcinoma.

Liver cancer is the sixth most common cancer in the world, with approximately 900,000 patients diagnosed each year. It is also the third leading cause of cancer death, with only about 7% of advanced-stage patients surviving more than five years.

Imfinzi is an anti-PD-L1 monoclonal antibody that blocks the binding of PD-L1 to PD-1 and CD80 proteins, relieving the suppression of immune responses by tumor cells. It has been approved in multiple countries and regions for the treatment of extensive-stage small cell lung cancer and has received FDA approval for the treatment of non-small cell lung cancer and advanced bladder cancer.

Tremelimumab blocks the activity of CTLA-4, thereby promoting T-cell activation and stimulating the immune system's response to cancer. When used in combination with Imfinzi and chemotherapy in a Phase III clinical trial for first-line treatment of Stage IV non-small cell lung cancer, it significantly improved overall patient survival.

In the Phase III clinical trial named HIMALAYA, patients first received a combination dose of tremelimumab and Imfinzi, followed by Imfinzi monotherapy every four weeks. This dosing regimen aims to stimulate T-cell activation while reducing the toxic side effects of the CTLA-4 antibody.

The trial results showed that patients treated with this dosing regimen had a 22% reduction in the risk of death compared to the active control group (HR=0.78, 96.02% CI 0.65-0.93, p=0.0035). The median overall survival was 16.4 months, compared to 13.8 months in the active control group. Approximately 31% of patients were still alive three years after receiving the treatment, compared to 20% in the control group.

The objective response rate of the Tremelimumab and Imfinzi combination was 20.1%, higher than 5.1% in the control group. For detailed data, please refer to the table below:

Image source: Reference [1]

References:

[1]Imfinzi plus tremelimumab demonstrated unprecedented survival in 1st-line unresectable liver cancer with 31% of patients alive at three years. Retrieved January 18, 2022, from https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2022/imfinzi-plus-tremelimumab-unprecedented-survival-1st-line-unresectable-liver-cancer.html

(Original text has been abridged)

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