AstraZeneca's anti-CTLA-4 immunotherapy Imjudo (tremelimumab) has won approval from the Ministry of Food and Drug Safety for the first-line treatment of liver cancer, making the first dual immunotherapy available in Korea.

The ministry on Friday approved Imjudo as the "first-line treatment of adult patients with advanced or unresectable hepatocellular carcinoma in combination with another anti-PD-L1 immunotherapy, Imfinzi (durbalumab)."

Its specific dosing regimen is the STRIDE (Single Tremelimumab Regular Interval Durvalumab), which consists of a single dose of 1,500 mg of Imfinzi plus 300 mg of Imfinzi, followed by additional doses of Imfinzi at regular intervals of every four weeks.

Imfinzi is an anti-PD-L1 immunotherapy introduced to Korea by AstraZeneca in 2018. It is used to treat locally advanced non-small cell lung cancer (NSCLC) and biliary tract cancer.

The Imfinzi-Imjudo combo therapy is the first dual immunotherapy to demonstrate a higher overall survival (OS) benefit than conventional sorafenib (Nexavar) as the first-line treatment of liver cancer. With the ministry’s approval of Imjudo, liver cancer patients in Korea can use dual immunotherapy.

Currently, the combination of the anti-PD-L1 immunotherapy Tecentriq (atezolizumab) and the anti-VEGF antibody Avastin (bevacizumab) is the standard care for first-line treatment of liver cancer in Korea.

The Tecentriq-Avastin combination has improved response rates and long-term survival benefits compared to sorafenib monotherapy. It won approval as the first-line treatment of liver cancer in Korea in May 2022.

However, due to the risk of bleeding, a side effect of Avastin, there was an unmet need for precautionary measures, such as ligation in some patients, or the use of TKI monotherapy, such as sorafenib or Lenvima (lenvatinib).

The Imfinzi-Imjudo combo therapy has won recognition as the treatment that can be used without the bleeding concerns of Avastin or the hepatotoxicity of TKIs.

In the HIMALAYA study, a phase 3 clinical trial to win approval, the Imfinzi-Imjudo combination reduced the risk of death by 22 percent compared to sorafenib monotherapy, demonstrating an improvement in the primary endpoint of OS.

The safety profile of Imfinzi plus Imjudo vs. Imfinzi alone was consistent with the known profile of each drug, and no new safety indications were identified.