New Protocol: Pembrolizumab with CISplatin and Gemcitabine in Metastatic Biliary Tract Cancer
Study
Phase III, double-blind, randomized, controlled, multicenter, open-label trial (KEYNOTE-966)
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Previously untreated, unresectable, locally advanced or metastatic biliary tract cancer
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Pembrolizumab + Gemcitabine + Cisplatin (n=533) vs. Gemcitabine + Cisplatin (n=536)
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Efficacy
mPFS: 6.5 vs 5.6 mos, p=0.023
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6-mo PFS: 52% vs. 46%
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12-mo PFS: 25% vs 20%
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mOS: 12.7 vs. 10.9 mos , p=0034
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12 months OS: 52% vs.44%
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24 months OS: 25% vs.18%
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mDoR: 9.7 vs 6.9 mos
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Safety
Grade≥3 AEs: Neutropenia (49% vs 45%), Anemia (29% vs. 29%), fatigue (6% vs. 4%)
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Pembrolizumab in combination with gemcitabine and cisplatin compared with gemcitabine and cisplatin alone for patients with advanced biliary tract cancer (KEYNOTE-966): a randomized, double-blind, placebo-controlled, phase 3 trial
Reviewed by Elvin Chalabiyev, MD on May 20, 2023
