Journal article
Final results of KEYNOTE-355: Randomized, double-blind, phase 3 study of pembrolizumab plus chemotherapy vs placebo plus chemotherapy for previously untreated locally recurrent inoperable or metastatic triple-negative breast cancer
Javier Cortes, David W Cescon, Hope S Rugo, Zbigniew Nowecki, Seock-Ah Im, Mastura Md Yusof, Carlos Gallardo, Oleg Lipatov, Carlos Henrique Barrios, Jose Perez-Garcia, Hiroji Iwata, Norikazu Masuda, Marco Torregroza Otero, Erhan Gokmen, Sherene Loi, Zifang Guo, Xuan Zhou, Vassiliki Karantza, Wilbur Pan, Peter Schmid
CANCER RESEARCH | AMER ASSOC CANCER RESEARCH | Published : 2022
Abstract
Abstract Background: In the phase 3 KEYNOTE-355 trial (NCT02819518), pembrolizumab (pembro) combined with chemotherapy (chemo) showed statistically significant improvements in OS and PFS compared to placebo + chemo in patients with previously untreated locally recurrent inoperable or metastatic TNBC whose tumors expressed PD-L1 with a combined positive score (CPS) ≥10. There were no statistically significant differences between treatment groups in the CPS ≥1 population, and statistical significance was not tested in the ITT population due to the prespecified testing strategy. Here, we compare outcomes in subgroups of patients by additional CPS cut-offs to the primary results o..
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