103P Time-dependent censoring imbalance and robustness of PFS and OS estimates in trials supporting EMA approval of first-line anti–PD-1/PD-L1 therapy for PD-L1–high advanced NSCLC
In first-line advanced non-small cell lung cancer (NSCLC) with PD-L1 ≥50%, immune checkpoint inhibitors (ICIs) improve progression-free survival (PFS) and overall survival (OS). Standard survival analyses assume non-informative censoring, an assumption that may be violated in open-label immunotherapy trials. We assessed the magnitude, timing, and impact of censoring imbalance on survival estimates in pivotal trials supporting EMA approval.
Authors
- Luca Longo (ORCID: https://orcid.org/0000-0002-5153-4243)
- M.C. Isernia
- Alberto Servetto (ORCID: https://orcid.org/0000-0003-3624-224X)
- Annarita Peddio
- Francesca Palomba (ORCID: https://orcid.org/0000-0001-7802-502X)
- Anna Russo (ORCID: https://orcid.org/0000-0002-0533-3053)
- Annarita Avanzo (ORCID: https://orcid.org/0009-0001-9249-8699)
- G.A.R.P. Aulisio
- D.L. Di Domenico
- R. Bianco
- G. Landi
- L. Formisano
- L. Liguori
- A. Santaniello
- S. D'Ambrosio
- A. Viggiano
- F. Napolitano
- F. Vitale
- F. Salomone
- F. Porcaro
Institutions
- University of Salerno (IT)
- University of Naples Federico II (IT)
Publication Details
- Journal
- ESMO Open
- Published
- 2026-03-17
- DOI
- https://doi.org/10.1016/j.esmoop.2026.106410
- Primary Topic
- Cancer Immunotherapy and Biomarkers
- Type
- article
- Field-Weighted Citation Impact
- 0.00