AstraZeneca’s Biologics License Application (BLA) for tremelimumab has been accepted for Priority Review in the US, the company has announced.
Tremelimumab is a human monoclonal antibody which AstraZeneca is investigating as a potential therapy for cancers. It works by targeting the activity of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4).
Now, tremelimumab has been accepted for an indication supporting a single priming dose added to the immunotherapy Imfinzi (durvalumab) for the treatment of patients with unresectable hepatocellular carcinoma (HCC) – a type of liver cancer.
A supplemental BLA (sBLA) has also been submitted for Imfinzi in this indication. The combination and dose of these therapies is called the STRIDE regimen (Single Tremelimumab Regular Interval Durvalumab).
According to Cancer Research UK, HCC is the most common type of liver cancer. It’s thought to be third leading cause of cancer death and the sixth most commonly diagnosed cancer in the world.
The BLA for tremelimumab and sBLA for Imfinzi are based on final results from the HIMALAYA Phase III trial1. In the trial, patients treated with the STRIDE regimen experienced a 22% reduction in the risk of death versus sorafenib (based on a hazard ratio [HR] of 0.78, 96.02% confidence interval [CI] 0.65-0.93; p=0.0035). Nearly one in three (31%) patients were still alive at three years versus one in five (20%) for sorafenib.
Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “The HIMALAYA Phase III trial showed an unprecedented three-year overall survival in this setting with a single priming dose of tremelimumab added to Imfinzi, highlighting the potential for this regimen to improve longer-term survival outcomes. Patients with advanced liver cancer are in great need of new treatment options, and we are working closely with the FDA to bring this novel approach to patients in the US as soon as possible.”