Selpercatinib and the Crossover Conundrum: Potential Impact of Postprogression Therapies on Overall Survival
fusion-positive non-small cell lung cancer, highlight the challenges of interpreting OS in trials with high crossover rates and variable postprogression therapies. Trial results demonstrated a large improvement in progression-free survival with an acceptable safety profile, but were accompanied by an immature OS analysis with a hazard ratio of 1.26, favoring the chemoimmunotherapy arm. Regardless of the position of OS in the end point hierarchy, it is critical that OS analyses include prespecified plans for data collection and analytical methods to account for the potential impact of postprogression therapies on the interpretation of study results.
Authors
- Diana Bradford (ORCID: https://orcid.org/0000-0002-5208-8222)
- R. Angelo de Claro (ORCID: https://orcid.org/0000-0001-8362-1977)
- Elizabeth S. Duke (ORCID: https://orcid.org/0000-0002-3361-1436)
- A. K. Sinha (ORCID: https://orcid.org/0000-0002-1687-1869)
- Nicole Drezner (ORCID: https://orcid.org/0000-0001-6299-9823)
- Erin Larkins (ORCID: https://orcid.org/0000-0002-7860-0546)
- Pallavi S. Mishra‐Kalyani (ORCID: https://orcid.org/0000-0003-2309-0179)
- Xiaoxue Li (ORCID: https://orcid.org/0000-0002-9484-3409)
Institutions
- United States Food and Drug Administration (US)
- Center for Drug Evaluation and Research (US)
Publication Details
- Journal
- Journal of Clinical Oncology
- Published
- 2026-04-17
- DOI
- https://doi.org/10.1200/jco-25-02375
- Primary Topic
- Cancer Immunotherapy and Biomarkers
- Type
- article
- Field-Weighted Citation Impact
- 0.00