Miguel Ángel Climent, Carlos Álvarez, Rafael Morales, Pablo Maroto, Alejo Rodríguez-Vida, María José Méndez-Vidal, Xavier García del Muro, Javier Puente, Nuria Láinez, Sergio Vázquez, Daniel Castellano, Carmen Gómez Lang, Jing Wang, Alessandra di Pietro, Craig Davis, Belén Sanz-Castillo, M. Victoria Bolós, Begoña P. Valderrama
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引用次数: 0
Abstract
Purpose
Post hoc analysis of the JAVELIN Bladder 100 trial of avelumab maintenance in locally advanced/metastatic urothelial carcinoma (la/mUC) to determine the interaction by programmed death ligand 1 (PD-L1) status for overall survival (OS), and additional analyses of survival per a different PD-L1 expression cutoff of ≥ 1% in tumor cells or immune cells (TC/IC).Please check and confirm that the authors and their respective affiliations have been correctly identified and amend if necessary.Everything is correct
Methods
JAVELIN Bladder 100 data were used for the analysis of the interaction by PD-L1 status (per cutoff used in the trial) for OS and, additionally, OS and progression-free survival (PFS) analyses per a different ≥ 1% TC/IC PD-L1 expression cutoff (Ventana SP263 assay).
Results
No significant interaction between treatment and PD-L1 status was observed for OS. Clinically meaningful and robust survival data were observed in favor of avelumab using the different ≥ 1% TC/IC PD-L1 expression cutoff.
Conclusions
These results demonstrate the benefit of avelumab maintenance in la/mUC regardless of PD-L1 expression, consistent with approved labels.