A phase 3 study of chemotherapy + pembrolizumab vs chemotherapy + placebo as neoadjuvant/adjuvant treatment for patients with gastric or gastroesophageal junction (G/GEJ) cancer: KEYNOTE-585 - Trial in progress

Introduction: Pembrolizumab monotherapy demonstrated promising efficacy and manageable safety patients with advanced metastatic G/GEJ adenocarcinoma who have received ≥2 prior lines of therapy, resulting in FDA approval for patients with PD-L1–positive tumors (combined positive score [CPS] ≥1) whose disease progressed on or after ≥2 prior lines of therapy. When combined with cisplatin and 5-fluorouracil (5-FU), pembrolizumab demonstrated promising efficacy and manageable safety in patients with previously untreated metastatic G/GEJ cancer in the phase 2 KEYNOTE-059 study.