2024 World Conference on Lung Cancer (WCLC) - ePosters-EP.12G.01 PFS as a Surrogate Endpoint for OS in Real-World Patients with ROS1+ advNSCLC in the United States

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The study investigates the applicability of progression-free survival (PFS) as a surrogate endpoint for overall survival (OS) in patients with advanced non-small cell lung cancer (advNSCLC) associated with ROS1 rearrangements in the United States. Utilizing a large electronic health record (EHR)-derived database, the study primarily analyzes the correlation between real-world PFS (rwPFS) and real-world OS (rwOS), as well as real-world response (rwR) and rwOS. This approach could facilitate more efficient clinical and pricing decisions in the absence of mature OS data.<br /><br />Key findings suggest that median rwPFS is 7.5 months, with a median rwOS of 30.6 months. Notably, disease progression within 12 months correlates with a higher risk of mortality, indicated by a hazard ratio of 2.1. Similarly, patients treated with oral targeted therapy as a standard care exhibited a median rwPFS of 8.6 months and a median rwOS of 29.1 months. Statistical analyses employing Spearman’s rho and Kendall’s tau positioned the correlation between rwPFS and rwOS as moderate.<br /><br />Despite these insights, the study acknowledges several limitations, including potential bias in treatment initiation timing and unmeasured confounding factors that could influence rwOS and rwPFS estimates. Also, the evolving landscape of clinical guidelines during the study may introduce variability in treatment approaches, complicating results' interpretation.<br /><br />Conclusively, while the study supports rwPFS as a potential surrogate for rwOS, authors advocate for further research to validate the correlation at the trial or cohort level, thus enhancing clinical and reimbursement decision frameworks in the context of immature OS data for ROS1 advNSCLC.<br /><br />Overall, this research suggests a promising avenue for leveraging intermediate endpoints like rwPFS in evaluating treatment efficacy and guiding healthcare decisions for ROS1 advNSCLC patients.

Asset Subtitle

Xinran Ma

Meta Tag

Speaker Xinran Ma

Topic Metastatic Non-small Cell Lung Cancer – Targeted Therapy

Keywords

progression-free survival

overall survival

non-small cell lung cancer

ROS1 rearrangements

electronic health record

real-world data

surrogate endpoint

oral targeted therapy

hazard ratio

clinical decision-making