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

Clinical and Translational Oncology Pub Date : 2023-12-15 DOI:10.1007/s12094-023-03358-4

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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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.

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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

目的对阿维列单抗维持治疗局部晚期/转移性尿路上皮癌（la/mUC）的JAVELIN Bladder 100试验进行事后分析，以确定程序性死亡配体1（PD-L1）状态对总生存期（OS）的交互作用，并根据肿瘤细胞或免疫细胞（TC/IC）中≥1%的不同PD-L1表达截断值对生存期进行额外分析。请检查并确认作者及其各自的所属单位是否已被正确识别，如有必要请进行修改。方法JAVELIN Bladder 100数据被用于分析PD-L1状态（按试验中使用的截断值）对OS的交互作用，以及按不同的≥1% TC/IC PD-L1表达截断值（Ventana SP263检测）进行的OS和无进展生存期（PFS）分析。使用不同的≥1% TC/IC PD-L1 表达截止值，观察到的有临床意义的、稳健的生存数据有利于阿维单抗。结论这些结果表明，无论 PD-L1 表达如何，阿维单抗在 la/mUC 中的维持治疗均有获益，这与批准的标签一致。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Clinical and Translational Oncology

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