Dr. Sun on the KEYNOTE-062 Design in Advanced Gastric/GEJ Cancer

Weijing Sun, MD, FACP, professor of medicine, The Sprint Professorship of Medicine Oncology, University of Kansas School of Medicine, director, Division of Medical Oncology, associate director, University of Kansas Cancer Center, discusses the design of the KEYNOTE-062 trial in advanced gastric/gastroesophageal junction (GEJ) cancer.

The randomized, phase 3 KEYNOTE-062 trial was a complex study that evaluated whether checkpoint inhibitors could be used in the frontline setting, as a single agent or in combination with chemotherapy, in patients with advanced gastric cancer, says Sun. Moreover, the analysis had a hierarchical design and consisted of 3 treatment arms. Patients were randomized 1:1:1 to receive pembrolizumab (Keytruda), pembrolizumab plus chemotherapy, or chemotherapy plus placebo. The primary end points of the trial were overall survival and progression-free survival in patients with PD-L1 combined positive score of 1 or greater, which was considered a noninferiority evaluation.

The results, which were published in JAMA Oncology in September 2020, showed that among 763 enrolled patients with untreated, locally advanced/unresectable or metastatic gastric/GEJ cancer, pembrolizumab was noninferior to chemotherapy in terms of OS. Fewer adverse effects were also observed with the investigational regimen, Sun concludes.