FDA Approves AstraZeneca’s Imjudo for Combination Liver Cancer Treatment

On Oct. 24, 2022, AstraZeneca announced that FDA has approved Imjudo (tremelimumab), a human monoclonal antibody (mAb), in combination with Imfinzi (durvalumab), also a human mAb, for treating adult patients with unresectable hepatocellular carcinoma (HCC). HCC is the most common type of liver cancer.

The approval was based on positive results from a Phase III trial (HIMALAYA), which demonstrated that patients treated with the combination of Imjudo and Imfinzi experienced a 22% reduction in the risk of death compared to sorafenib, an oral kinase inhibitor used to treat late-stage liver cancer. The results of the Phase III trial also showed evidence that the combination therapy allowed an estimated 31% of patients to live three years after administration, compared to 20% of sorafenib-treated patients, who showed the same longevity.

The novel dose and schedule of combination entails a single dose of Imjudo at 300 mg added to Imfinzi at 1500 mg, and this regimen is followed by Imfinzi every four weeks. In addition to the United States, regulatory applications for Imjudo in combination with Imfinzi are currently under review in Europe, Japan, and several other countries.

“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, MD, attending physician at Memorial Sloan Kettering Cancer Center and principal investigator in the HIMALAYA Phase III trial, in an AstraZeneca company press release.

“With this first regulatory approval for Imjudo, patients with unresectable liver cancer in the US now have an approved dual immunotherapy treatment regimen that harnesses the potential of CTLA-4 [cytotoxic T-lymphocyte-associated protein 4] inhibition in a unique combination with a PD-L1 [programmed cell death ligand 1] inhibitor to enhance the immune response against their cancer,” said Dave Fredrickson, executive vice-president, Oncology Business Unit, AstraZeneca, in the release.

Source: AstraZeneca