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Overall Survival Update on Durvalumab Plus Chemotherapy for Advanced Biliary Tract Cancer

By: Julia Fiederlein
Posted: Monday, October 17, 2022

The preplanned interim analysis of the phase III TOPAZ-1 trial demonstrated significantly improved overall survival outcomes in patients with advanced biliary tract cancer who received chemotherapy plus the monoclonal antibody durvalumab versus a placebo, according to Do-Youn Oh, MD, PhD, of Seoul National University College of Medicine, Korea, and colleagues. The results of an updated overall survival and safety analysis, which were presented during the European Society for Medical Oncology (ESMO) Congress 2022 (Abstract 56P), further support these findings.

“With limited treatment advances over the past decade, these patients have long faced a dismal prognosis,” Dr. Oh commented in a press release. “For the first time, an immunotherapy-based combination has shown the ability to alter the course of treatment for this disease and should become the new standard of care.”

A total of 685 previously untreated patients were randomly assigned in a 1:1 ratio to receive gemcitabine plus cisplatin in combination with either durvalumab or a placebo, followed by monotherapy with durvalumab or the placebo until disease progression or unacceptable toxicity. Follow-up data were provided for a median of 23.4 and 22.4 months, respectively.

The median duration of overall survival was 12.9 months with durvalumab and 11.3 months with the placebo (hazard ratio = 0.76). Overall survival hazard ratios were found to favor durvalumab in all prespecified subgroups, including disease status (initially unresectable: 0.79; recurrent: 0.76), primary tumor location (intrahepatic cholangiocarcinoma: 0.78; extrahepatic cholangiocarcinoma: 0.61; gallbladder cancer: 0.90), and PD-L1 (≥ 1%: 0.75; < 1%: 0.79). At 12, 18, and 24 months, the rates of overall survival were 54.3%, 34.8%, and 23.6% with durvalumab and 47.1%, 24.1%, and 11.5% with the placebo, respectively.

Grade 3 or 4 treatment-related adverse events were reported in 60.9% of patients treated with durvalumab and 63.5% of those who received the placebo. A total of 8.9% and 11.4% of patients, respectively, experienced treatment-related adverse events leading to the discontinuation of any study medication.

Disclosure: For full disclosures of the study authors, visit

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