US FDA approves Keytruda® combined with trastuzumab and chemotherapy for gastric cancer

The US FDA have approved Keytruda® (pembrolizumab), an anti-PD-1 therapy, in combination with trastuzumab and chemotherapy, for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma. “This is the first time an anti-PD-1 therapy has been approved in combination with anti-HER2 therapy and chemotherapy as a first-line treatment for these patients,” commented Roy Baynes (Merck Research Laboratories, NJ, USA). The approval is based on ongoing Phase III KEYNOTE-811 trial. The results thus far have demonstrated an objective response rate of 74% (95% CI, 66-82) for patients who received the regimen with pembrolizumab...