New Indication: Durvalumab with CISplatin and Gemcitabine in Biliary Tract Cancers
Study
Double-blind, placebo-controlled, phase 3 study
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Untreated unresectable or metastatic biliary tract cancer
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Gemcitabine – cisplatin plus Durvalumab (341) or placebo (344)
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Efficacy
24 month OS: 24.9% vs. 10.4%
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ORR: 26.7% vs. 18.7%
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mPFS: 7.2 mos vs. 5.7 mos (HR:0.75, P=0.001)
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DOR: 7.3 mos vs. 5.8 mos
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Safety
Any grade AEs: 99.4% vs 98.8%, anemia:48.2%-44.7%, nausea: 40.2%-34.2, neutropenia:31.7%-31%
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Grade ≥3 AEs: 75.7% vs 77.8%
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Deaths due to adverse events: 3.6% vs 4.1%
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Immune-mediated AEs: 12.7% – 4.7%
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{“Do-Youn Oh et al.”}Durvalumab plus Gemcitabine and Cisplatin in Advanced Biliary Tract Cancer
Reviewed by Hasan Cagri Yildirim, MD on Nov 26, 2022
