Full Efficacy & Safety Summary Table
Indication | In combination with trastuzumab + chemo in 1L HER+ metastatic Gastric/GEJ |
Registrational Trial | Phase 3 Randomized (n=264), Interim data from KEYNOTE-811 trial (NCT03615326) |
Regimen | 200 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 Outcomes | ORR: 74% vs 52% (trastuzumab + chemo control) DOR: 10.6 mo vs 9.5 mo |
Safety Outcomes | Consistent with known safety profiles of individual agents |