On 1 May 2024, MSD announced that the final analysis of the Phase 3 KEYNOTE-811 clinical trial (sponsored by MSD) demonstrated that Keytruda® (pembrolizumab), in combination with trastuzumab and chemotherapy, provided gastric cancer patients with a statistically significant and clinically meaningful improvement, meeting its dual primary endpoint of overall survival.
In May 2021, the FDA approved Ketyruda® in combination with trastuzumab and chemotherapy for first line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma. The indication was approved under the FDA’s Accelerated Approval Program, which requires that studies are conducted to confirm the anticipated clinical benefit. MSD reports that the final results from the KEYNOTE-811 trial will determine if Keytruda will receive continued FDA approval for the gastric cancer indication.
In February 2024, Keytruda® (with trastuzumab and chemotherapy) was approved in Canada for the same gastric cancer indication, based on earlier results of the KEYNOTE-811 study in relation to its dual primary endpoint of progression-free survival.