The USFDA has approved an immune checkpoint inhibitor drug called durvalumab in combination with gemcitabine and cisplatin for adult patients with locally advanced or metastatic biliary tract cancer. The drug was previously approved for patients with lung cancer. How was efficacy evaluation done? Trial: The efficacy of durvalumab was tested in TOPAZ-1 (NCT03875235) – a randomized, double-blind, placebo-controlled, multiregional trial.
Samples: The study involved 685 patients with histologically confirmed, locally advanced, unresectable or metastatic biliary tract cancer, such as intrahepatic cholangiocarcinoma, gallbladder cancer, and extrahepatic cholangiocarcinoma. Patients who had not received systemic therapy for advanced disease were also included. Randomization: Patients were randomized in a 1:1 ratio and received 1500 mg durvalumab in combination with 1000 mg/m2 gemcitabine and…
