Randomized Double-Blind Phase II Study of Maintenance Pembrolizumab Versus Placebo After First-Line Chemotherapy in Patients With Metastatic Urothelial Cancer
AuthorGalsky, Matthew D
Milowsky, Matthew I
Fleming, Mark T
Dang, Long H
Geynisman, Daniel M
Alter, Robert S
Quinn, David I
Haines, G Kenneth
Hahn, Noah M
Pal, Sumanta K
AffiliationUniv Arizona, Dign Hlth St Josephs Hosp & Med Ctr, Canc Ctr
MetadataShow full item record
PublisherAMER SOC CLINICAL ONCOLOGY
CitationGalsky, M. D., Mortazavi, A., Milowsky, M. I., George, S., Gupta, S., Fleming, M. T., ... & Pal, S. K. (2020). Randomized double-blind phase II study of maintenance pembrolizumab versus placebo after first-line chemotherapy in patients with metastatic urothelial cancer. Journal of Clinical Oncology, 38(16), 1797-1806.
JournalJOURNAL OF CLINICAL ONCOLOGY
Rights© 2020 by American Society of Clinical Oncology.
Collection InformationThis item from the UA Faculty Publications collection is made available by the University of Arizona with support from the University of Arizona Libraries. If you have questions, please contact us at firstname.lastname@example.org.
AbstractBetween December 2015 and November 2018, 108 patients were randomly assigned to pembrolizumab (n = 55) or placebo (n = 53). The objective response rate was 23% with pembrolizumab and 10% with placebo. Treatment-emergent grade 3-4 adverse events occurred in 59% receiving pembrolizumab and 38% of patients receiving placebo. Progression-free survival was significantly longer with maintenance pembrolizumab versus placebo (5.4 months [95% CI, 3.1 to 7.3 months] v 3.0 months [95% CI; 2.7 to 5.5 months]; hazard ratio, 0.65; log-rank P = .04; maximum efficiency robust test P = .039). Median overall survival was 22 months (95% CI, 12.9 months to not reached) with pembrolizumab and 18.7 months (95% CI, 11.4 months to not reached) with placebo. There was no significant interaction between PD-L1 CPS ≥ 10 and treatment arm for progression-free survival or overall survival.
Note12 month embargo; first published online 9 April 2020
VersionFinal published version
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