AstraZeneca's CTLA-4/PD-L1 Antibody Combination for First-Line Unresectable Hepatocellular Carcinoma Enters FDA Priority Review

Today, AstraZeneca announced that the U.S. FDA has accepted the company's Biologics License Application (BLA) for its investigational CTLA-4 antibody tremelimumab and will review it through the priority review pathway. Tremelimumab is to be used in combination with the anti-PD-L1 antibody Imfinzi (durvalumab) to treat patients with unresectable hepatocellular carcinoma. This innovative dosing regimen, called STRIDE, involves initial treatment with a single dose of tremelimumab followed by continuous treatment with Imfinzi. AstraZeneca submitted this BLA using a priority review voucher and is expected to receive a response from the FDA in the fourth quarter of this year.

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-related deaths, 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. Used in combination with Imfinzi and chemotherapy, it significantly improved overall survival in patients with Stage IV non-small cell lung cancer in a Phase III clinical trial for first-line treatment.

This BLA is based on the final results of the Phase 3 clinical trial, HIMALAYA. In this trial, the risk of death was reduced by 22% (HR=0.78, 96.02% CI, 0.65-0.93, p=0.0035) in patients receiving the STRIDE regimen compared to the active control group. Nearly one-third (31%) of patients survived more than three years, compared to 20% in the active control group.

Note: The original text has been abridged.

References:

[1] Tremelimumab accepted under Priority Review in the US for patients with unresectable liver cancer in combination with Imfinzi. Retrieved April 25, 2022, from https://www.businesswire.com/news/home/20220425005340/en

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