AstraZeneca’s Imjudo (tremelimumab) – an anti-CTLA4 antibody – in combination with Imfinzi (durvalumab) – an anti-PD-L1 antibody – has been approved by the US Food and Drug Administration (FDA) for the treatment of adult patients with unresectable hepatocellular carcinoma (HCC), the most common type of liver cancer.
The dosing schedule of the combination has been referred to as the STRIDE (Single Tremelimumab Regular Interval Durvalumab) regimen, which includes a single dose of Imjudo 300mg added to Imfinzi 1500mg followed by Imfinzi every four weeks.
The approval is based on positive results from the global phase 3 HIMALAYA trial, a randomised, open-label, multicentre study in 1,324 patients with unresectable, advanced HCC who had not been treated with prior systemic therapy and were not eligible for locoregional therapy.
The study showed that patients treated with the combination experienced a 22% in the risk of death versus sorafenib, a standard of care multi-kinase inhibitor.
Results were also published in the New England Journal of Medicine Evidence showing that an estimated 31% of patients treated with the combination were still alive after three years, with 20% of patients treated with sorafenib still alive at the same duration of follow-up.
The safety profiles of the combination of Imjudo added to Imfinzi and for Imfinzi alone were consistent with the known profiles of each medicine, the company reported, and no new safety signals were identified.
HCC is a complex and heterogeneous tumour most commonly associated with underlying chronic liver disease, especially hepatitis. Around 75% of all primary liver cancers in adults are HCC, with more than half of patients diagnosed at advanced stages of the disease, often when symptoms first appear.
“Patients with unresectable liver cancer are in need of well-tolerated treatments that can meaningfully extend overall survival,” said Ghassan Abou-Alfa, attending physician at Memorial Sloan Kettering Cancer Center (MSK), and principal investigator in the HIMALAYA trial.
He continued: “In addition to this regimen demonstrating a favourable three-year survival rate in the HIMALAYA trial, safety data showed no increase in severe liver toxicity or bleeding risk for the combination, important factors for patients with liver cancer who also have advanced liver disease.”
Regulatory applications for Imjudo in combination with Imfinzi are currently under review in Europe, Japan and several other countries for the treatment of patients with advanced liver cancer based on the HIMALAYA results, the company outlined in a statement.