Imfinzi and tremelimumab granted Orphan Drug Designation in the US for liver cancer

AstraZeneca's Imfinzi (durvalumab) and tremelimumab, an anti-CTLA4 antibody and potential new medicine, have both been granted Orphan Drug Designation (ODD) in the US for the treatment of hepatocellular carcinoma (HCC), the most common type of liver cancer. The US Food and Drug Administration (FDA) grants ODD to medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US. Liver cancer is the third leading cause of cancer death worldwide and for patients with unresectable or advanced disease, only 13% are alive five years after diagnosis.(1-3) José Baselga, Executive Vice President, Oncology R&D, said: "Many patients with liver cancer are diagnosed and treated only after the disease is advanced, and there is an urgent need for new effective and tolerable treatments. We are eager to bring new potential options to these patients and look forward to the results of our ongoing Phase III HIMALAYA trial later this year." The Phase III HIMALAYA trial is testing Imfinzi and the combination of Imfinzi plus tremelimumab in patients with unresectable, advanced HCC who have not been treated with prior systemic therapy and are not eligible for locoregional therapy (treatment localised to the liver). HIMALAYA is the first trial to test dual immune checkpoint blockade in the 1st-line advanced HCC setting. Imfinzi is not currently approved to treat HCC in any country, alone or in combination with tremelimumab. Hepatocellular carcinoma (HCC) Liver cancer is the third leading cause of cancer death and the sixth most commonly diagnosed cancer worldwide.(1) HCC represents about 80% of all primary liver cancers.(4) Approximately 700,000 people were diagnosed with HCC around the world in 2018, and an estimated 42,000 people were diagnosed in the US last year.(1,2) Between 80-90% of all patients with HCC also have chronic liver disease, which is primarily caused by infection with the hepatitis B or C viruses.(5,6) Chronic liver disease is associated with inflammation that, over time, results in immunosuppression and can lead to the development of HCC.(7,8) The unique immune environment of liver cancer provides clear rationale for researching medicines that harness the power of the immune system to treat HCC.(9) A critical unmet need exists for patients with HCC who face limited treatment options.(10) More than half of patients are diagnosed at advanced stages of the disease, often when symptoms first appear.(11,12) HIMALAYA HIMALAYA is a randomised, open-label, multicentre, global Phase III trial of Imfinzi monotherapy and the combination of Imfinzi and tremelimumab vs. the standard-of-care medicine sorafenib, a multi-kinase inhibitor, in patients with unresectable, advanced HCC who have not been treated with prior systemic therapy and are not eligible for locoregional therapy. The trial is being conducted in 189 centres across 16 countries including in the US, Canada, Europe, South America and Asia. The primary endpoint is overall survival and key secondary endpoints include objective response rate and progression-free survival.

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