The US Food and Drug Administration (FDA) has granted approval for AstraZeneca’s Imjudo (tremelimumab) plus Imfinzi (durvalumab) to treat adults with unresectable hepatocellular carcinoma (HCC), a kind of liver cancer.
The dosage and schedule of the combination treatment is named the STRIDE regimen (Single Tremelimumab Regular Interval Durvalumab).
This regimen comprises a 300mg dose of Imjudo plus 1,500mg Imfinzi, with subsequent doses of Imfinzi administered every four weeks.
Based on positive data from the open-label, international, randomised, multicentre Phase III HIMALAYA clinical trial, the regulatory agency granted the approval.
According to the findings, subjects who received Imjudo plus Imfinzi had a 22% decline in the mortality risk versus sorafenib.
Additionally, nearly 31% of subjects who received the combination treatment were still alive after three years, compared to 20% in the sorafenib arm.
A human monoclonal antibody, Imfinzi attaches to the PD-L1 protein and hinders the PD-L1 interaction with the PD-1 and CD80 proteins.
Imjudo is also a human monoclonal antibody and hinders cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) activity.
AstraZeneca Oncology Business Unit executive vice-president Dave Fredrickson said: “With this first regulatory approval for Imjudo, patients with unresectable liver cancer in the US now have an approved dual immunotherapy treatment regimen that harnesses the potential of CTLA-4 inhibition in a unique combination with a PD-L1 inhibitor to enhance the immune response against their cancer.”
Regulatory applications for combination therapy for advanced liver cancer treatment are currently being reviewed in Japan, Europe and various other countries.