The P-III (KEYNOTE-811) study assesses Keytruda + trastuzumab & CT vs PBO + trastuzumab & CT as a 1L treatment of locally advanced unresectable or metastatic HER2+ G/GEJ adenocarcinoma
The final analysis depicted an improved OS among the ITT population along with advantages in patients with PD-L1-expressing tumors. The study already met the dual 1EP of PFS, highlighted at ESMO 2023
Additionally, Keytruda + trastuzumab, fluoropyrimidine & Platin based CT received accelerated approval for the same indication supported by the ORR & DoR results from the KEYNOTE-811 study. Complete approval will be based on the final analysis verification
Ref: Merck | Image: Merck
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