ASCO 2023 | KEYNOTE-361 and -045: pembrolizumab monotherapy in urothelial carcinoma

For patients with advanced urothelial carcinoma (UC), pembrolizumab monotherapy has shown antitumor activity as first-line therapy in the Phase III KEYNOTE-361 (NCT02853305) study, and as second-line therapy in the Phase III KEYNOTE-045 (NCT02256436) study. Patrizia Giannatempo, MD, Foundation IRCCS National Cancer Institute, Milan, Italy, shares an exploratory analysis evaluating the efficacy and safety of pembrolizumab monotherapy by UC histology in the KEYNOTE-361 and KEYNOTE-045 trials. The analysis included patients with pure transitional cell (TC) histology and those with mixed predominant TC histology. The results showed that pembrolizumab demonstrated similar progression-free survival (PFS), objective response rate (ORR), duration of response (DOR), and overall survival (OS) in both histology subgroups. The safety profile of pembrolizumab was also comparable between the two subgroups. However, the study noted limitations, such as small sample size in some subgroups and limited data to classify histology subgroups. These findings suggest that pembrolizumab monotherapy shows consistent clinical activity and safety regardless of histology in patients with UC. This interview took place at the American Society of Clinical Oncology (ASCO) 2023 Annual Congress in Chicago, IL.

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