New Reference: Pembrolizumab with Chemotherapy in Advanced Gastric Cancer
Study
Double-blind, multicenter, randomised, phase 3 study (Keynote 859)
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Previously untreated locally advanced/metastatic HER2 negative GEJ and gastric adenocancer
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Pembrolizumab + Cht (n=790) vs. PBO + Cht (n=789)
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Efficacy
ITT
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mOS: 12.9 vs 11.5 mos, HR:0.78, p<0.001
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mPFS: 6.9 vs. 5.6 mos, HR:0.76, p<0.001
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CPS≥1 group:
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mOS: 13.0 vs 11.4 mos, HR:0.74, p<0.001
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mPFS: 6.9 vs. 5.6 mos, HR:0.72, p<0.001
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CPS≥10 group:
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mOS: 15.7 vs 11.8 mos, HR:0.65, p<0.001
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mPFS: 8.1 vs. 5.6 mos, HR:0.62, p<0.001
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Safety
Grade≥3 AEs: Neutropenia (9% vs.8%), anemia (9% vs.7%), thrombocytopenia (7% vs 5%).
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Pembrolizumab plus chemotherapy versus placebo plus chemotherapy for HER2-negative advanced gastric cancer (KEYNOTE-859): a multicentre, randomised, double-blind, phase 3 trial
Reviewed by Elvin Chalabiyev, MD on Nov 20, 2023