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 ^[6] ; Carlos Álvarez ^[1] ; Rafael Morales ^[7] ; Pablo Maroto ^[8] ; Alejo Rodríguez Vida ^[9] ; María José Méndez Vidal ^[10] ; Xavier García del Muro ^[2] ; Javier Puente ^[3] ; Nuria Láinez ^[11] ; Sergio Vázquez ^[4] ; Daniel Castellano ^[5] ; Carmen Gómez Lang ^[12] ; Jing Wang ^[13] ; Alessandra di Pietro ^[14] ; Craig Davis ^[15] ; Belén Sanz Castillo ^[16] ; M. Victoria Bolós ^[16] ; Begoña P. Valderrama ^[17]
  1. [1] Hospital Universitario Central de Asturias

     Hospital Universitario Central de Asturias

     Oviedo, España

     
  2. [2] Institute Catalá Oncología

     Institute Catalá Oncología

     Barcelona, España

     
  3. [3] Hospital Clínico San Carlos de Madrid

     Hospital Clínico San Carlos de Madrid

     Madrid, España

     
  4. [4] Hospital Universitario Lucus Augusti

     Hospital Universitario Lucus Augusti

     Lugo, España

     
  5. [5] Hospital Universitario 12 de Octubre

     Hospital Universitario 12 de Octubre

     Madrid, España

     
  6. [6] Valencian Institute of Oncology, Valencia, Spain
  7. [7] Vall d’Hebron University Hospital, Barcelona, Spain
  8. [8] Hospital Universitari de La Santa Creu I Sant Pau, Barcelona, Spain
  9. [9] Hospital del Mar-CIBERONC, IMIM Research Institute, Barcelona, Spain
  10. [10] Maimonides Institute for Biomedical Research of Cordoba (IMIBIC), Reina Sofa University Hospital (HURS), Cordoba, Spain
  11. [11] University Hospital of Navarra, Pamplona, Spain
  12. [12] Merck S.L.U., an Afliate of Merck KGaA, Madrid, Spain
  13. [13] Pfizer, Cambridge, MA, USA
  14. [14] Pfizer Srl, Milan, Italy
  15. [15] Pfizer Translational Oncology, La Jolla, CA, USA
  16. [16] Pfizer Oncology, Madrid, Spain
  17. [17] Virgen del Rocío University Hospital, Seville, Spain

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• Localización: Clinical & translational oncology, ISSN 1699-048X, Vol. 26, Nº. 6, 2024, págs. 1532-1538
• Idioma: inglés
• Texto completo no disponible (Saber más ...)
• Resumen

  • 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.