The Final Results of KEYNOTE-361 - Ajjai Alva

October 26, 2020

Immune checkpoint blockade therapy by blocking PD-1/PD-L1 axis signaling is approved in advanced urothelial cancers in a few settings: (1) first-line therapy for platinum-ineligible patients, (2) first-line therapy in cisplatin-ineligible patients with high PD-L1 expression, (3) maintenance therapy for patients who do not progress with first-line chemotherapy, and (4) as subsequent therapy for patients progressing after cisplatin-based first-line therapy. Regulatory approvals for settings #1 and #2 are based on single-arm phase 2 data, with setting #3 based on the JAVELIN-100 Bladder randomized control trial. To explore the efficacy of combining anti-PD-1 therapy with chemotherapy in platinum-eligible patients as first-line therapy, KEYNOTE-361 was designed as a randomized trial in which pembrolizumab maintenance therapy was given up to two years. Dual primary endpoints were progression-free and overall survival. Alicia Morgans, MD, MPH, and Ajjai Alva, MBBS, MD  discuss the final results from the KEYNOTE-361 trial which he presented the final results from at the 2020 European Society for Medical Oncology Virtual Congress.  


Ajjai S. Alva, MBBS, MD Associate Professor of Medicine and a Medical Oncologist at the University of Michigan Medicine Urology Oncology Clinic, Rogel Cancer Center, Ann Arbor, MI

Alicia Morgans, MD, MPH Associate Professor of Medicine in the Division of Hematology/Oncology at the Northwestern University Feinberg School of Medicine in Chicago, Illinois.