According to a story from finance.yahoo.com, a new treatment regimen has been approved by the US Food and Drug Administration (FDA) for hepatocellular carcinoma that cannot be treated with surgery. This combination consists of tremelimumab (marketed as IMJUDO), developed by AstraZeneca, and durvalumab (marketed as IMFINZI). This treatment consists of a distinct schedule and dose and is known as the Single Tremelimumab Regular Interval Durvalumab (STRIDE) regimen.
About Hepatocellular Carcinoma (HCC)
Hepatocellular carcinoma is a type of liver cancer. Although generally considered rare, at least in developed countries, it is the most widespread type of cancer to originate in the liver in adults and is also the most common cause of death for people who develop cirrhosis. Risk factors are generally any condition that can lead to long term liver damage and cirrhosis, such as certain genetic disorders, chronic hepatitis, type 2 diabetes, nonalcoholic steatohepatitis, and severe alcohol abuse. The cancer is associated with common symptoms of liver dysfunction and damage, such as jaundice, fatigue, abdominal swelling, nausea and vomiting, bruising easily, abdominal pain, loss of appetite, and weight loss. Treatment may include kinase inhibitors, surgery, liver transplant, arterial catheters, and ablation. Survival rates are poor; cancer that cannot be removed with surgery is usually lethal within a year. To learn more about hepatocellular carcinoma, click here.
Trial Findings
This approval is the result of positive results from a Phase 3 clinical trial in which patients that received treatment with the STRIDE regimen saw a 22 percent reduction in their risk of death when compared to patients that were being treated with sorafenib. Additionally, an estimated 31 percent of patients receiving the therapy were alive after three years, compared to just 20 percent with sorafenib. The safety profile of the regimen was aligned to the profiles of both medicines separately. The trial included a total of 1,324 patients with unresectable hepatocellular carcinoma. The STRIDE regimen comprises a 300mg ‘priming’ IMJUDO dose added to a 1500mg dose of IMFINZI, followed by continued doses of IMFINZI once a month.
Hepatocellular carcinoma is the fastest increasing cause of cancer-attributed death in the US, so there is an urgent need for more effective treatments that can increase survival and slow disease progression. The combination is also under consideration for approval in the EU and Japan.
