The association between baseline hepatic or renal function and clinical outcomes for patients with NSCLC treated with a PD-1/PD-L1 blocking antibody using real-world and trials data

May 15, 2023


Drugs that block PD-1/L1 activity have been effective in treating many types of cancer. However, limited data exists on the use of these treatments in some vulnerable patient subgroups, including patients with organ impairment, because exclusion criteria often limits their participation in clinical trials. Previous studies have shown that patients with advanced melanoma and baseline hepatic or renal impairment often have poorer clinical outcomes than patients with normal organ function, but there is a lack of data for patients with non-small cell lung cancer (NSCLC). 

To address this knowledge gap, researchers from the FDA and Flatiron Health used real-world data (RWD) and pooled patient-level clinical trial data to analyze the association between baseline organ function and overall survival in patients with advanced NSCLC who were treated with PD-1/L1 blocking antibodies.

Why this matters

By analyzing both RWD and clinical trials, this research may provide valuable and hypothesis generating insights for the treatment of patients with organ impairment that is unavailable elsewhere. Results may inform treatment decision and provide evidence supporting the expansion of eligibility criteria in future trials. Using RWD also increases the generalizability of study results by evaluating patients with a broad range of renal and hepatic function. This collaborative research shows promise that RWD can complement clinical trial data in better understanding populations underrepresented in clinical trials. 

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