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Review
. 2023 Nov;18(6):965-972.
doi: 10.1007/s11523-023-01007-y. Epub 2023 Nov 9.

Durvalumab: A Review in Advanced Biliary Tract Cancer

Simon Fung  1 , Yahiya Y Syed  2
Affiliations
Review

Durvalumab: A Review in Advanced Biliary Tract Cancer

Simon Fung et al. Target Oncol. 2023 Nov.

Erratum in

Abstract

Durvalumab (Imfinzi®), a therapeutic human monoclonal antibody which binds to and blocks the activity of the immunosuppressive programmed death-ligand 1 (PD-L1) protein, is approved in the USA, EU, Japan and other countries in combination with gemcitabine and cisplatin for adults with advanced biliary tract cancer. In the pivotal phase 3 TOPAZ-1 trial, durvalumab plus gemcitabine and cisplatin significantly prolonged overall survival and progression-free survival compared with placebo plus gemcitabine and cisplatin in adults with advanced biliary tract cancer. Benefit from durvalumab was seen irrespective of primary tumour location, disease status at diagnosis (unresectable or recurrent), or initial levels of PD-L1 expression. The tolerability of durvalumab plus gemcitabine and cisplatin was manageable. Overall, the addition of durvalumab to gemcitabine and cisplatin is a valuable new treatment option for adults with advanced biliary tract cancer.

Plain language summary

Biliary tract cancers are a diverse group of cancers that develop in the bile ducts or the gallbladder. Patients with these cancers typically have poor survival. Chemotherapy (gemcitabine plus cisplatin) has been the first-line treatment for biliary tract cancer for over a decade, with no new treatments further improving on its overall survival benefit until recently. Durvalumab (Imfinzi®) belongs to a class of drugs known as checkpoint inhibitors; these drugs activate the immune system to help fight cancer. In the phase 3 TOPAZ-1 trial, the addition of durvalumab to first-line chemotherapy prolonged the overall survival compared with placebo plus chemotherapy in adults with advanced biliary tract cancer. The tolerability of durvalumab in combination with chemotherapy was manageable. Thus, durvalumab plus gemcitabine and cisplatin is a valuable new treatment option for adults with advanced biliary tract cancer.

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Conflict of interest statement

S. Fung and Y. Y. Syed are salaried employee of Adis International Ltd/Springer Nature, and declare no relevant conflicts of interest. All authors contributed to this article and are responsible for its content.

Figures

Fig. 1
Fig. 1
The most common (≥ 5% of patients) grade 3 or 4 treatment-related adverse events in patients receiving durvalumab or placebo in combination with gemcitabine and cisplatin in TOPAZ-1 [17]. GC gemcitabine plus cisplatin, pts patients
See this image and copyright information in PMC

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