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Imfinzi improved survival in biliary tract cancer
Imfinzi improved survival in biliary tract cancer.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \n \n \n RNS Number : 1081Q\n AstraZeneca PLC\n 25 October 2021\n \n \n \n \n 25 October 2021 7:00 BST\n \n \n \n \n \n \n Imfinzi \n \n \n plus chemotherapy significantly improved overall survival in 1st-line advanced biliary tract cancer in TOPAZ-1 Phase III trial at interim analysis\n \n \n \n \n \n \n First immunotherapy combination to demonstrate superior clinical outcomes \n \n \n over standard of care in a global, randomised trial in this setting \n \n \n \n \n \n Positive high-level results from the TOPAZ-1 Phase III trial showed Imfinzi (durvalumab), in combination with standard-of-care chemotherapy, demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit versus chemotherapy alone as a 1st-line treatment for patients with advanced \n biliary tract cancer\n (BTC\n ).\n \n \n \n \n \n At a predefined interim analysis, the Independent Data Monitoring Committee concluded that the trial met the primary endpoint by demonstrating an improvement in OS \n in patients treated with Imfinzi plus chemotherapy versus chemotherapy alone. The combination also demonstrated an improvement in progression-free survival (PFS) and overall response rate, key secondary endpoints. \n \n \n \n \n \n \n Imfinzi \n \n plus chemotherapy was well tolerated, had a similar safety profile versus the comparator arm and did not increase the discontinuation rate due to adverse events compared to chemotherapy alone. \n \n \n \n \n \n BTC is a group of rare and aggressive cancers that occur in the bile ducts and gallbladder.1,2 Incidence of BTC often depends on the prevalence of common risk factors for each type within a geographical region. \n \n \n \n \n \n Approximately 50,000 people in the US, Europe and Japan and about 210,000 people worldwide are diagnosed with BTC each year.3-5 These patients have a poor prognosis, with approximately only 5% to 15% of all patients with BTC surviving five years.4 In December 2020, Imfinzi was granted Orphan Drug Designation in the US for the treatment of BTC. \n \n \n \n \n \n Do-Youn Oh, MD, PhD, Professor, Division of Medical Oncology, Department of Internal Medicine at Seoul National University Hospital and Seoul National University College of Medicine, and principal investigator in the TOPAZ-1 Phase III trial, s...