FDA Clears Novel Liver Cancer Combo Treatment

Regulators have approved Imjudo, a monoclonal antibody that targets the activity CTLA-4, to be used in combination with Imfinzi, a PD-L1 inhibitor.

The FDA has cleared AstraZeneca’s Imjudo (tremelimumab) in combination with the blockbuster drug Imfinzi (durvalumab) for unresectable hepatocellular carcinoma (HCC), the most common type of liver cancer.

Imjudo will be commercially available in the United States in early November 2022, Chelsea Ford, director of external communications for AstraZeneca U.S. Corporate Affairs, told FormularyWatch.

The cost of the new Imjudo-Imfinzi regimen, which will be published in a few days, will be “comparable to other approved combination treatments in the liver cancer space,” Ford said.

The novel dose and schedule of the combination, called STRIDE regimen (Single Tremelimumab Regular Interval Durvalumab), includes a single dose of the anti-CTLA-4 antibody Imjudo 300 mg added to the anti-PD-L1 antibody Imfinzi 1500 mg, followed by Imfinzi every four weeks, AstraZeneca said in a news release.

“With this first regulatory approval for Imjudo, patients with unresectable liver cancer in the United States now have an approved dual immunotherapy treatment regimen that harnesses the potential of CTLA-4 inhibition in a unique combination with a PD-L1 inhibitor to enhance the immune response against their cancer,” Dave Fredrickson, executive vice president of AstraZeneca’s Oncology Business Unit, said in a press release.

The FDA’s approval was based on positive results from the HIMALAYA phase 3 trial, in which patients treated with the Imjudo and Imfinzi combination experienced a 22% reduction in the risk of death versus sorafenib (Nexavar, Bayer).

A study published in the New England Journal of Medicine Evidence also found that an estimated 31% of patients treated with the combination were still alive after three years, and 20% of patients treated with sorafenib were still alive at the same duration of follow-up.

Liver cancer is the fastest rising cause of cancer-related deaths in the US, with about 36,000 new diagnoses each year, AstraZeneca said.

“Patients with unresectable liver cancer are in need of well-tolerated treatments that can meaningfully extend overall survival. In addition to this regimen demonstrating a favorable three-year survival rate in the HIMALAYA trial, safety data showed no increase in severe liver toxicity or bleeding risk for the combination, important factors for patients with liver cancer who also have advanced liver disease,” said Ghassan Abou-Alfa, M.D., attending physician at Memorial Sloan Kettering Cancer Center and principal investigator in the HIMALAYA phase 3 trial.

Regulatory appliations for Imjudo in combination with Imfinzi are currently under review in Europe, Japan and several other countries for the treatment of patients with advanced liver cancer based on the HIMALAYA results, according to AstraZeneca.