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

Climent, Miguel Ángel; Álvarez, Carlos; Morales-Barrera, Rafael; Maroto, Pablo; Rodriguez-Vida, Alejo; Méndez-Vidal, María José; García del Muro, Xavier; Puente, Javier; Láinez, Nuria; Vázquez, Sergio; Castellano, Daniel; Gómez Lang, Carmen; Wang, Jing; Di Pietro, Alessandra; Davis, Craig; Sanz Castillo, Belén; Bolós, M. Victoria; Valderrama, Begoña P.

doi:http://dx.doi.org/10.1007/s12094-023-03358-4

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

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

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.