AstraZeneca's Dual Immunotherapy Imfinzi (durvalumab) + Imjudo (tremelimumab) Receives FDA Approval for Unresectable Hepatocellular Carcinoma

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News on October 25, 2022 / BIOON / -- AstraZeneca recently announced that the U.S. Food and Drug Administration (FDA) has approvedAnti-CTLA-4 Therapy Imjudo (tremelimumab) in Combination with Anti-PD-L1 Therapy Imfinzi (Generic Name: durvalumab): For the Treatment of Adult Patients with Unresectable Hepatocellular Carcinoma (HCC). This combination features a new drug delivery and treatment regimen, namedSTRIDE Regimen (Single Tremelimumab Regular Interval Durvalumab): A single dose of Imjudo 300mg in combination with Imfinzi 1500mg, followed by Imfinzi administered every 4 weeks.

This approval is based on the positive results of the HIMALAYA Phase 3 trial. The data shows:In patients with unresectable advanced hepatocellular carcinoma (HCC) who had not received prior systemic therapy and were ineligible for locoregional treatment, the STRIDE regimen demonstrated significant survival benefits compared to oral multikinase inhibitor sorafenib: it significantly reduced the risk of death by 22% (HR=0.78; 95% CI: 0.66-0.92; p=0.0035).

The study results have also been published in the prestigious international medical journal, The New England Journal of Medicine (NEJM):The STRIDE regimen group estimated that 31% of patients were still alive after 3 years, while the sorafenib treatment group had only 20% of patients surviving within the same follow-up period.. Safety data show,The STERID regimen does not increase the risk of severe hepatotoxicity or bleeding, which is an important factor in liver cancer patients with advanced liver disease.. (See details:Tremelimumab plus Durvalumab in Unresectable Hepatocellular Carcinoma。）

AstraZeneca’s Executive Vice President, Oncology Business Unit, Dave Fredrickson, said: "With the first regulatory approval of Imjudo, patients in the United States with unresectable liver cancer now have an approved dual immunotherapy option.This approach leverages the potential of CTLA-4 inhibition, uniquely combined with a PD-L1 inhibitor, to enhance the body's immune response against cancer.”

Results of the HIMALAYA Trial (Source: AstraZeneca)

Liver cancer is the third leading cause of cancer death globally and the sixth most common type of cancer worldwide. Hepatocellular carcinoma (HCC) accounts for approximately 75% of primary liver cancers in adults. Each year, about 80,000 people in the United States, the European Union, and Japan, and around 26,000 people in China are diagnosed with advanced, unresectable HCC. Among patients with HCC, approximately 80-90% also have cirrhosis, primarily caused by hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Chronic liver disease is associated with inflammation, which over time leads to immune suppression and can contribute to the development of HCC.

The unique immune environment of liver cancer provides a clear theoretical basis for researching drugs that harness the power of the immune system to treat HCC. For HCC patients facing limited treatment options, there is a critical unmet medical need.More than half of the patients are affected in the late stage of the disease.DiagnosisTypically, it occurs when symptoms first appear. In patients with advanced HCC, the 5-year survival rate is only 7%.

Imfinzi (Yingfufan, Durvalumab) is a human monoclonal antibody that targets and binds to the programmed cell death ligand 1 (PD-L1), blocking the interaction between PD-L1 and PD-1 and CD80, countering the tumor's immune evasion strategy and releasing the suppression of the immune response.

Based on the results of the Phase 3 TOPAZ-1 study, Imfinzi has recently received U.S. FDA approval for the treatment of advanced biliary tract cancer. Based on the results of the Phase 3 PACIFIC study, Imfinzi is the only approved immunotherapy for curative treatment in patients with unresectable locally advanced (Stage III) non-small cell lung cancer (NSCLC) following chemoradiation and has now become the global standard of care. Based on the results of the Phase 3 CASPIAN study, Imfinzi has also been approved in many countries worldwide (including the United States, the entire European Union, China, and Japan) for the treatment of extensive-stage small cell lung cancer (ES-SCLC). Additionally, Imfinzi has also been approved in several countries for the treatment of previously treated patients with advanced bladder cancer.

The active ingredient in Imjudo is tremelimumab, a human monoclonal antibody that targets cytotoxic T-lymphocyte antigen 4 (CTLA-4), blocking CTLA-4 activity and promoting T-cell activation.Tumor ImmunologyReact and promote cancer cell death. Tremelimumab targets the same point CTLA-4 as Bristol-Myers Squibb's marketed antibody drug Yervoy (Ipilimumab).

As part of a new drug research and development project, Imfinzi is currently being explored for its therapeutic potential in non-small cell lung cancer, small cell lung cancer, bladder cancer, head and neck cancer, liver cancer, cervical cancer, biliary tract cancer, and other solid tumors, either as a monotherapy or in combination with tremelimumab and other drugs. (Bioon.com)

Source: Imjudo (tremelimumab) in combination with Imfinzi approved in the US for patients with unresectable liver cancer