According to the results, a single priming dose of Imjudo added to Imfinzi, called the STRIDE regimen, reduced the risk of death by 22% compared to sorafenib at four years of follow-up
An image of AstraZeneca Cambridge Biomedical Campus. (Credit: AstraZeneca)
AstraZeneca has announced that Imfinzi (durvalumab) plus Imjudo (tremelimumab) showed a sustained, clinically meaningful overall survival (OS) benefit at four years for patients suffering from unresectable hepatocellular carcinoma (HCC) in HIMALAYA Phase III trial.
Imfinzi is a human monoclonal antibody that targets the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins.
Imjudo is a human monoclonal antibody that targets the activity of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). It blocks the activity of CTLA-4 to activate T-cell activation and support the death of cancer cells.
The Phase III trial evaluated patients who had not received prior systemic therapy and were not eligible for localised treatment.
According to the results, a single priming dose of Imjudo added to Imfinzi, called the STRIDE (Single Tremelimumab Regular Interval Durvalumab) regimen, reduced the risk of death by 22% compared to sorafenib at four years of follow-up.
Additionally, around 25.2% of patients who received the STRIDE regimen were still alive at four years compared to 15.1% of patients who received sorafenib, a standard-of-care multi-kinase inhibitor.
An ad-hoc exploratory analysis revealed that, regardless of the underlying disease cause, or other baseline demographics, the treatment effects of the STRIDE regimen versus sorafenib were uniform across all clinically relevant subgroups of patients, as well as those surviving for at least three years.
AstraZeneca Oncology R&D EVP Susan Galbraith said: “The remarkable four-year survival benefit shown with Imfinzi and Imjudo in this advanced liver cancer setting supports the use of the STRIDE regimen to treat a broad, eligible patient population globally.
“These latest results from HIMALAYA are part of a series of clinical trials aiming to deliver innovative treatments for patients at different stages of liver cancer.”
HIMALAYA is a randomised, open-label, multicentre, global Phase III trial that enrolled 1,324 patients. It involved Imfinzi monotherapy and a regimen of a single priming dose of Imjudo 300mg and Imfinzi 1,500mg followed by Imfinzi every four weeks (STRIDE regimen) versus sorafenib.
The primary endpoint was defined as OS for the combination versus sorafenib. The key secondary endpoints included OS for Imfinzi versus sorafenib, objective response rate and progression-free survival for the Imfinzi plus Imjudo combination and for Imfinzi alone.