In October 2022, the FDA approved the new immunotherapy, Imjudo (tremelimumab; from AstraZeneca), a CTLA-4 monoclonal antibody, in combination with another immunotherapy, Imfinzi (durvalumab; from AstraZeneca), a PD-L1 inhibitor, for the treatment of adults with unresectable (can’t be removed by surgery) hepatocellular carcinoma, or liver cancer.
“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 [side effects] or bleeding risk for the combination,” said principal investigator Ghassan Abou-Alfa, MD, MBA, Attending Physician, Memorial Sloan Kettering Cancer Center, New York City.
The FDA approved this new immunotherapy for use in combination with another immunotherapy by comparing the results in 782 patients who received either the immunotherapy combination or Nexavar (sorafenib), a multi-kinase inhibitor currently used in patients with liver cancer.
The combination of Imjudo plus Imfinzi significantly extended survival compared with Nexavar. The average overall survival was 16.4 months with the 2 immunotherapies versus 13.8 months with Nexavar. After 18 months of therapy, the overall survival was 47.4% with the 2 immunotherapies versus 41.5% with Nexavar; after 2 years of therapy, survival rates were about 40% with the immunotherapy combination and 33% with Nexavar.
Overall, 20.1% of patients responded to the immunotherapy combination compared with only 5.1% of patients who responded to Nexavar treatment.
The most common side effects with the immunotherapy combination were rash, diarrhea, fatigue, pruritus, musculoskeletal pain, and abdominal pain.