Trial shows an improved survival rate at 4 years when treated with the STRIDE regimen in comparison to treatment with sorafenib in patients with unresectable hepatocellular carcinoma.
Results of the HIMALAYA phase 3 trial show that durvalumab (Imfinzi; AstraZeneca) plus tremelimumab-actl (Imjudo; AstraZeneca) demonstrated a clinically meaningful, sustained overall survival (OS) benefit at 4 years for patients with unresectable hepatocellular carcinoma (HCC), presenters announced at the 2023 European Society for Medical Oncology (ESMO) World Congress on Gastrointestinal Cancer in Barcelona, Spain.
At a 4-year follow-up point, a single priming dose of tremelimumab-actl added to durvalumab, called the Single Tremelimumab Regular Interval Durvalumab (STRIDE) regimen, resulted in a 22% (hazard ratio [HR] of 0.78; 95% confidence interval [CI] 0.67-0.92; 78% data maturity) reduction in death when compared to treatment with sorafenib (Nexavar; Bayer), according to the study.
“Historically, only 7% of patients with advanced liver cancer have survived 5 years, making the HIMALAYA long-term survival data especially meaningful,” said Bruno Sangro, MD, PhD, a lead investigator in the trial. “One in 4 patients treated with the STRIDE regimen were still alive at 4 years, reinforcing this novel regimen as a standard of care in this setting.”
According to the study, an estimated 25.2% of patients treated with the STRIDE regimen were alive at 4 years compared to 15.1% for those treated with sorafenib.
Further, an exploratory analysis showed that the treatment effects for the STRIDE regimen versus sorafenib were consistent across all clinically relevant subgroups of patients—including those surviving at least 3 years—regardless of the cause of underlying disease or other demographics, according to the results of the study.
“The remarkable 4-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,” Susan Galbraith, executive vice president of Oncology R&D at AstraZeneca, said in the release. “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.”
AstraZeneca. Imfinzi (durvalumab) plus Imjudo (tremelimumab-actl) demonstrated sustained overall survival benefit in advanced liver cancer with an unprecedented one in four patients alive at four years in HIMALAYA Phase III trial. News release. Published June 29, 2023. Available at https://www.businesswire.com/news/home/20230629262663/en.