Imfinzi (durvalumab) + Imjudo (tremelimumab) demonstrated unprecedented overall survival in advanced liver cancer with one in five patients surviving five years in HIMALAYA phase III trial – AstraZeneca

Updated results from the HIMALAYA Phase III trial showed AstraZeneca’s Imfinzi (durvalumab) plus Imjudo (tremelimumab) demonstrated a sustained, clinically meaningful overall survival (OS) benefit at five years for patients with unresectable hepatocellular carcinoma (HCC) who had not received prior systemic therapy and were not eligible for localised treatment. These results from HIMALAYA will be presented at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain (presentation 947MO).

At five years of follow-up, this latest exploratory analysis showed that a single priming dose of Imjudo added to Imfinzi, called the STRIDE regimen (Single Tremelimumab Regular Interval Durvalumab), reduced the risk of death by 24% compared to sorafenib (based on a hazard ratio [HR] of 0.76; 95% confidence interval [CI] 0.65-0.89). An estimated 19.6% of patients treated with the STRIDE regimen were alive at five years versus 9.4% of those treated with sorafenib.

In a subgroup analysis of patients in the trial who achieved disease control, defined as complete or partial response or stable disease, 28.7% of those treated with the STRIDE regimen were alive at five years versus 12.7% of patients treated with sorafenib. In addition, an exploratory analysis of depth of response (DpR) showed that more patients treated with the STRIDE regimen experienced deep responses leading to longer survival compared to sorafenib.

Lorenza Rimassa, MD, Associate Professor of Medical Oncology, Humanitas University and IRCCS Humanitas Research Hospital, Milan, Italy and a lead investigator in the HIMALAYA trial, said: “Treatment with durvalumab plus tremelimumab for patients with advanced liver cancer doubled the overall survival rate at five years, a significant survival advantage over sorafenib that has also become even more pronounced over time. These data reinforce the use of this novel dual immunotherapy regimen and are an important milestone for patients with this devastating disease.”

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “It is remarkable to see nearly 20 per cent of patients with advanced liver cancer treated with the STRIDE regimen alive at five years compared to only about seven per cent of patients living that long historically. This is a major step forward, setting a new survival benchmark. This underscores our commitment to following patients for the long term to help us better characterise the enduring clinical benefits of this innovative priming approach with an anti-CTLA-4 antibody added to PD-L1 blockade.”