First immunotherapy combination to demonstrate superior clinical outcomes over standard of care in a global, randomised trial in this setting
Positive high- position 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 ( Zilches) benefit versus chemotherapy alone as a 1st- line treatment for cases with advanced biliary tract cancer (BTC).
At a predefined interim analysis, the Independent Data Monitoring Committee concluded that the trial met the primary endpoint by demonstrating an enhancement in OS in cases treated with Imfinzi plus chemotherapy versus chemotherapy alone. The combination also demonstrated an enhancement in progression-free survival (PFS) and overall response rate, crucial secondary endpoints.
Imfinzi plus chemotherapy was well permitted, had a analogous safety profile versus the comparator arm and didn’t increase the termination rate due to adverse events compared to chemotherapy alone.
BTC is a group of rare and aggressive cancers that do in the corrosiveness tubes and gallbladder Prevalence of BTC frequently depends on the frequence of common threat factors for each type within a geographical region.
Roughly people in the US, Europe and Japan and about people worldwide are diagnosed with BTC eachyear.3-5 These cases have a poor prognostic, with roughly only 5 to 15 of all cases with BTC surviving five times.4 In December 2020, Imfinzi was granted Orphan Drug Designation in the US for the treatment of BTC.
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 top investigator in the TOPAZ-1 Phase III trial, said “ Cases with advanced biliary tract cancer are in dire need of new treatments as progress in the 1st- line setting has remained largely stagnant for further than 10 times. TOPAZ-1 is the first Phase III trial to show that adding an immunotherapy to standard chemotherapy delivers a meaningful overall survival benefit for cases in this setting. Moment’s instigative results are a major step forward in treating this complaint and represent new stopgap for our cases.”
Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said “ We’re pleased TOPAZ-1 has been unblinded beforehand due to clear substantiation of efficacity for Imfinzi plus chemotherapy, which has also demonstrated a strong safety profile. We’ve now delivered two positive gastrointestinal cancer trials in a row for Imfinzi, following the HIMALAYA trial in liver cancer. We believe the significant survival benefit demonstrated marks a new period of immunotherapy treatment in this ruinous complaint, and it advances our commitment to perfecting long- term survival for cases across these cancers where treatment options are limited.”
The data will be presented at a forthcoming medical meeting and participated with health authorities.
Biliary tract cancer
Biliary tract cancer (BTC) is a group of rare and aggressive gastrointestinal (GI) cancers that form in the cells of the corrosiveness tubes (cholangiocarcinoma), gallbladder or ampulla of Vater (where the corrosiveness conduit and pancreatic conduit connect to the small intestine) Cholangiocarcinoma is more common in China and Thailand and is on the rise in Westerncountries.8-10 Gallbladder cancer is more common in certain regions of South America, India and Japan
Piecemeal from ampullary cancer, early- stage BTC frequently presents without symptoms and utmost new cases of BTC are thus diagnosed at an advanced stage, when treatment options are limited and the prognostic is poor
TOPAZ-1 is a randomised, double-eyeless, placebo controlled, multicentre, global Phase III trial of Imfinzi in combination with chemotherapy (gemcitabine plus cisplatin) versus placebo in combination with chemotherapy as a 1st- line treatment in 685 cases with unresectable advanced or metastatic BTC including intrahepatic and extrahepatic cholangiocarcinoma, and gallbladder cancer (ampullary melanoma was barred).
The trial is being conducted in further than 145 centres across 17 countries including in the US, Europe, South America and several countries in Asia including South Korea, Thailand, Japan, Taiwan and China. The primary endpoint is OS and crucial secondary endpoints include progression-free survival, objective response rate and safety.
AstraZeneca (LSE/ STO/ Nasdaq AZN) is a global, wisdom- led biopharmaceutical company that focuses on the discovery, development, and commercialisation of tradition drugs in Oncology, Rare Conditions, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Grounded in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative drugs are used by millions of cases worldwide.
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