Merck has announced that its blockbuster drug Keytruda met one of its primary endpoints in a Phase III trial for patients with esophageal cancer. The results are an important step toward full approval of the drug for this indication. Merck is now working with the FDA to update the current indication for Keytruda "to those patients whose tumors are PD-L1 positive" following positive results from a study known as KEYNOTE-811, which found that Keytruda in combination with Roche's Herceptin and chemotherapy showed statistically significant improvements in progression-free survival compared to placebo when used to treat HER2-positive advanced gastric or gastroesophageal junction adenocarcinoma.
Keytruda was granted accelerated approval by the FDA in May 2021 for the first-line treatment of locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma based on tumor shrinkage data. Stomach cancer is the fourth leading cause of cancer deaths worldwide, and more than 70% of patients with this type of cancer develop advanced-stage disease.
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