UK-based pharmaceutical company AstraZeneca has reported positive results from the Phase III HIMALAYA trial of Imfinzi (durvalumab) plus Imjudo (tremelimumab) in advanced liver cancer patients.
The combination therapy showed a sustained, clinically meaningful overall survival (OS) benefit at five years in patients who were given the combination therapy.
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This marks the longest survival follow-up reported for a Phase III immunotherapy trial in this setting.
The open-label, randomised trial involved Imfinzi monotherapy and a regimen consisting of a single 300mg dose of Imjudo added to 1,500mg of Imfinzi, followed by Imfinzi every four weeks (STRIDE regimen) against the standard-of-care multi-kinase inhibitor sorafenib.
Imfinzi is a human monoclonal antibody that targets the PD-L1 protein, while Imjudo focuses on the CTLA-4 protein.
The two therapies form the STRIDE regimen, which has shown a 24% reduction in the risk of death compared with sorafenib.
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By GlobalDataAn estimated 19.6% of patients who were given the STRIDE regimen survived for five years, double the survival rate of those given sorafenib.
The regimen’s safety profile remained consistent with the known profiles of each medicine, with no new safety signals emerging from the extended follow-up.
AstraZeneca Oncology R&D executive vice-president Susan Galbraith said: “It is remarkable to see nearly 20% of patients with advanced liver cancer treated with the STRIDE regimen alive at five years compared to only about 7% of patients living that long historically.
“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.”
The combination of Imfinzi and Imjudo is currently approved for treating adults with advanced or unresectable hepatocellular carcinoma in the EU, US, Japan and several other countries.
Earlier this year, AstraZeneca reported positive data from the Phase III AMPLIFY clinical trial of Calquence (acalabrutinib) for treating chronic lymphocytic leukaemia.
