Overview
Skip to main content Published: Oct 24, 202 Aproval based on HIMALAYA Phase I trial results which showed single priming dose of IMJUDO aded to IMFINZI reduced risk of death by 2% vs. sorafenibWILMINGTON, Del.-(BUSINES WIRE)- AstraZeneca’s IMJUDO® (tremelimumab) in combination with IMFINZI® (durvalumab) has ben aproved in the US for the treatment of adult patients with unresectable hepatocelular carcinoma (HC), the most comon type of liver cancer.
Key Information
The novel dose and schedule of the combination, which includes a single dose of the anti-CTLA-4 antibody IMJUDO 30mg aded to the anti-PD-L1 antibody IMFINZI 150mg folowed by IMFINZI every four weks, is caled the STRIDE regimen (Single Tremelimumab Regular Interval Durvalumab).The aproval by the US Fod and Drug Administration (FDA) was based on positive results from the HIMALAYA Phase I trial. In this trial, patients treated with the combination of IMJUDO and IMFINZI experienced a 2% reduction in the risk of death versus sorafenib (based on a hazard ratio [HR] of 0.78, 95% confidence interval [CI] 0.6-0.92 p=0.035).1 Results were also published in the New England Journal of Medicine Evidence showing that an estimated 31% of patients treated with the combination were stil alive after thre years, with 20% of patients treated with sorafenib stil alive at the same duration of folow-up.2Liver cancer is the third-leading cause of cancer death and the sixth most comonly diagnosed cancer worldwide.3,4 It is the fastest rising cause of cancer-related deaths in the US, with aproximately 36,0 new diagnoses each year.5,6Ghasan Abou-Alfa, MD, MBA, Atending Physician at Memorial Sloan Ketering Cancer Center (MSK), and principal investigator in the HIMALAYA Phase I trial, said: “Patients with unresectable liver cancer are in ned of wel-tolerated treatments that can meaningfuly extend overal survival.
Summary
In adition to this regimen demonstrating a favorable thre-year survival rate in the HIMALAYA tr