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
{"title":"JAVELIN Bladder 100试验中按PD-L1状态和PD-L1表达对治疗亚组相互作用的探索性分析","authors":"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","doi":"10.1007/s12094-023-03358-4","DOIUrl":null,"url":null,"abstract":"<h3 data-test=\"abstract-sub-heading\">Purpose</h3><p>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</p><h3 data-test=\"abstract-sub-heading\">Methods</h3><p>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).</p><h3 data-test=\"abstract-sub-heading\">Results</h3><p>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.</p><h3 data-test=\"abstract-sub-heading\">Conclusions</h3><p>These results demonstrate the benefit of avelumab maintenance in la/mUC regardless of PD-L1 expression, consistent with approved labels.</p>","PeriodicalId":10166,"journal":{"name":"Clinical and Translational Oncology","volume":"34 1","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2023-12-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Exploratory analyses of treatment subgroup interaction by PD-L1 status and according to PD-L1 expression in the JAVELIN Bladder 100 trial\",\"authors\":\"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\",\"doi\":\"10.1007/s12094-023-03358-4\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<h3 data-test=\\\"abstract-sub-heading\\\">Purpose</h3><p>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</p><h3 data-test=\\\"abstract-sub-heading\\\">Methods</h3><p>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).</p><h3 data-test=\\\"abstract-sub-heading\\\">Results</h3><p>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.</p><h3 data-test=\\\"abstract-sub-heading\\\">Conclusions</h3><p>These results demonstrate the benefit of avelumab maintenance in la/mUC regardless of PD-L1 expression, consistent with approved labels.</p>\",\"PeriodicalId\":10166,\"journal\":{\"name\":\"Clinical and Translational Oncology\",\"volume\":\"34 1\",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2023-12-15\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinical and Translational Oncology\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1007/s12094-023-03358-4\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical and Translational Oncology","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1007/s12094-023-03358-4","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Exploratory analyses of treatment subgroup interaction by PD-L1 status and according to PD-L1 expression in the JAVELIN Bladder 100 trial
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.
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