AstraZeneca (AZ) has shared updated results from a late-stage study of its Imfinzi (durvalumab) plus Imjudo (tremelimumab) treatment plan in certain patients with hepatocellular carcinoma (HCC), the most common type of liver cancer.
The dosing schedule of the combination is referred to as the STRIDE (single tremelimumab regular interval durvalumab) regimen, which includes a single 300mg dose of Imjudo added to Imfinzi 1500mg, followed by Imfinzi every four weeks.
In the phase 3 HIMALAYA trial, the regimen was associated with a sustained and clinically meaningful overall survival benefit at four years in those with unresectable HCC who had not received prior systemic therapy and were not eligible for localised treatment, the company said.
The updated results from the study, which were presented at this year’s European Society for Medical Oncology (ESMO) World Congress on Gastrointestinal Cancer, show that treatment plan reduced the risk of death by 22% at four years compared to sorafenib, a standard of care multi-kinase inhibitor.
An estimated 25.2% of patients treated with the STRIDE regimen were alive at four years versus 15.1% for those treated with sorafenib.
An exploratory analysis also showed that the effects of the regimen versus sorafenib were consistent across all clinically relevant subgroups of patients, as well as those surviving at least three years, regardless of the underlying disease cause.
Bruno Sangro, a lead investigator in the trial, said: “Historically, only 7% of patients with advanced liver cancer have survived five years, making the HIMALAYA long-term survival data especially meaningful.
“One in four patients treated with the STRIDE regimen were still alive at four years, reinforcing this novel regimen as a standard of care in this setting.”
Approximately 75% of all primary liver cancers in adults are HCC and more than half of patients are diagnosed at advanced stages of the disease, often when symptoms first appear.
Susan Galbraith, executive vice president, oncology research and development, AZ, 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.”
Imfinzi plus Imjudo is already approved for certain adults with advanced or unresectable HCC in major markets, including in the US, EU and Japan.