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

Miguel Ángel Climent Durán, Carlos Álvarez Laso, Rafael Morales Barrera, Pablo Maroto Rey, Alejo Rodriguez Vida, María José Méndez Vidal, Xavier García del Muro, Javier Puente Vázquez, Nuria Láinez Milagro, Sergio Vázquez Estévez, Daniel Castellano-Gauna, Carmen Gómez Lang, Jing Wang, Alessandra di Pietro, Craig Davis, Belén Sanz Castillo, Victoria Bolós Fernández, B. Pérez Valderrama

• 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 diferent PD-L1 expression cutof 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 cutof used in the trial) for OS and, additionally, OS and progression-free survival (PFS) analyses per a diferent≥1% TC/IC PD-L1 expression cutof (Ventana SP263 assay).

  Results No signifcant 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 diferent≥1% TC/IC PD-L1 expression cutof.

  Conclusions These results demonstrate the beneft of avelumab maintenance in la/mUC regardless of PD-L1 expression, consistent with approved labels.