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Exploratory analyses of treatment subgroup interaction by PD-L1 status and according to PD-L1 expression in the JAVELIN Bladder 100 trial

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dc.contributor.author Climent, Miguel Ángel
dc.contributor.author Álvarez, Carlos
dc.contributor.author Morales-Barrera, Rafael
dc.contributor.author Maroto, Pablo
dc.contributor.author Rodríguez-Vida, Alejo
dc.contributor.author Méndez-Vidal, María José
dc.contributor.author García del Muro, Xavier
dc.contributor.author Puente, Javier
dc.contributor.author Láinez, Nuria
dc.contributor.author Vázquez, Sergio
dc.contributor.author Castellano, Daniel
dc.contributor.author Gómez Lang, Carmen
dc.contributor.author Wang, Jing
dc.contributor.author Di Pietro, Alessandra
dc.contributor.author Davis, Craig
dc.contributor.author Sanz Castillo, Belén
dc.contributor.author Bolós, M. Victoria
dc.contributor.author Valderrama, Begoña P.
dc.date.accessioned 2024-10-09T06:25:09Z
dc.date.available 2024-10-09T06:25:09Z
dc.date.issued 2024
dc.identifier.citation Climent MÁ, Álvarez C, Morales R, Maroto P, Rodríguez-Vida A, Méndez-Vidal MJ, et al. Exploratory analyses of treatment subgroup interaction by PD-L1 status and according to PD-L1 expression in the JAVELIN Bladder 100 trial. Clin Transl Oncol. 2024 Jun;26(6):1532-8. DOI: 10.1007/s12094-023-03358-4
dc.identifier.issn 1699-048X
dc.identifier.uri http://hdl.handle.net/10230/61360
dc.description.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). 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.
dc.format.mimetype application/pdf
dc.language.iso eng
dc.publisher Springer
dc.relation.ispartof Clin Transl Oncol. 2024 Jun;26(6):1532-8
dc.rights © The Author(s) 2023, corrected publication 2024. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
dc.rights.uri http://creativecommons.org/licenses/by/4.0/
dc.title Exploratory analyses of treatment subgroup interaction by PD-L1 status and according to PD-L1 expression in the JAVELIN Bladder 100 trial
dc.type info:eu-repo/semantics/article
dc.identifier.doi http://dx.doi.org/10.1007/s12094-023-03358-4
dc.subject.keyword Advanced urothelial carcinoma
dc.subject.keyword Avelumab
dc.subject.keyword Interaction test
dc.subject.keyword Maintenance treatment
dc.subject.keyword PD-L1
dc.rights.accessRights info:eu-repo/semantics/openAccess
dc.type.version info:eu-repo/semantics/publishedVersion

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