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Longitudinal tumor size and NLR are prognostic biomarkers for overall survival in advanced NSCLC patients treated with durvalumab.

Therapy optimization remains an important challenge in the treatment of advanced NSCLC. We investigated tumor size (sums of longest diameters of target lesions, SLD) and neutrophil-to-lymphocyte ratio (NLR) as longitudinal biomarkers for survival prediction. Datasets from 335 NSCLC patients, Study NCT02087423, and 202 patients, Study NCT01693562 of durvalumab were used for model qualification and validation, respectively. Nonlinear Bayesian joint models were designed to assess the impact of longitudinal measurements of SLD and NLR on patient subgrouping (by RECIST 1.1 criteria at 3 months after therapy start), long-term survival and precision of survival predictions. Various validation scenarios were investigated. We determined a more distinct patient subgrouping and a substantial increase in precision of survival estimates, upon incorporation of longitudinal measurements. The highest performance was achieved using a multivariate SLD and NLR model, which enabled predictions of NSCLC clinical outcomes.