“These new data from KEYNOTE-811, demonstrating a significant improvement in progression-free survival, are meaningful and build on the earlier insights from this study that supported the accelerated approval of this KEYTRUDA combination in the U.S. for certain patients with HER2-positive gastric or GEJ adenocarcinoma,” said Dr. Scot Ebbinghaus, vice president, global clinical development, Merck Research Laboratories. “We look forward to sharing these results with the medical community and regulatory authorities to ensure this KEYTRUDA-based regimen is available to appropriate patients, and we are working with the FDA to update the current indication for KEYTRUDA to those patients whose tumors are PD-L1 positive.”
