Powles T, Csőszi T, Özgüroğlu M, et al. - Among patients with previously untreated advanced urothelial carcinoma, a randomised, open-label, phase 3 trial (KEYNOTE-361) was performed to examine outcomes with first-line pembrolizumab alone or combined with chemotherapy vs chemotherapy. A total of 1010 patients were randomized to receive pembrolizumab plus chemotherapy (n = 351), pembrolizumab monotherapy (n = 307), or chemotherapy alone (n = 352). No significant improvement in progression-free survival or overall survival was seen in relation to pembrolizumab plus chemotherapy vs chemotherapy. In analyses of overall survival with pembrolizumab vs chemotherapy, similar overall survival was seen between these treatment arms, both in the overall population and the population with combined positive score of at least 10. Findings revealed that no significant improvement in efficacy was achieved with the addition of pembrolizumab to first-line platinum-based chemotherapy and hence this strategy should not be broadly employed for management of advanced urothelial carcinoma.