Publication: CPT: Pharmacometrics & Systems Pharmacology
Abstract
This study used model-based meta-analysis (MBMA) to assess how well objective response rate (ORR) predicts longer-term outcomes such as progression-free survival (PFS) and overall survival (OS) in patients with metastatic non-small-cell lung cancer (mNSCLC) treated with PD-1 or PD-L1 inhibitors. The authors analyzed data from 114 clinical studies, applying advanced statistical models to link short-term responses (ORR) with survival outcomes, while accounting for treatment type and clinical covariates such as PD-L1 expression and patient characteristics. They found that ORR is a meaningful predictor of both PFS and OS across treatments. The models were then used to simulate head-to-head comparisons between PD-1 and PD-L1 inhibitors, which showed trends favoring PD-1 agents numerically, although differences were not statistically significant. Overall, this work supports using early ORR data to inform late-stage trial design and decision making, enabling more evidence-based comparisons and reducing uncertainty when planning oncology development strategies.
Author(s): Richard C. Franzese, Li Qin, Shuai Fu, Benjamin Rich, Eleftherios Zografos, Matthew L. Zierhut, Sandra A. G. Visser
Published: February 18, 2026
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