Pembrolizumab (Keytruda) – 1L Gastric/GEJ

Full Efficacy & Safety Summary Table

IndicationIn combination with trastuzumab + chemo in 1L HER+ metastatic Gastric/GEJ
Registrational TrialPhase 3 Randomized (n=264), Interim data from KEYNOTE-811 trial (NCT03615326)
Regimen200 mg administered as intravenous infusion over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression
Efficacy OutcomesORR: 74% vs 52% (trastuzumab + chemo control)
DOR: 10.6 mo vs 9.5 mo
Safety OutcomesConsistent with known safety profiles of individual agents

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