Real-world outcomes of patients with metastatic non-small cell lung cancer treated with programmed cell death protein 1 inhibitors in the year following U.S. regulatory approval

Our summary

As new classes of therapies are approved and enter clinical practice, studies using real-world data can provide valuable information on generalizability of clinical trial evidence. Co-authored with the FDA, this study analyzed a large and recent real-world cohort to estimate real-world survival following treatment with PD-1 inhibitors, nivolumab and pembrolizumab, in the first year following regulatory approval for NSCLC.

Why this matters

When a novel therapeutic class becomes available to clinicians, the extent to which real- world practice may emulate clinical trial results is a common question. This study showed that, in the case of immunooncology in NSCLC, overall survival outcomes during the initial adoption period may have been somewhat shorter than the milestones reached in clinical trials, supporting the notion that there are clinically relevant differences between the restrictive conditions of a clinical trial (selected patient populations, protocol-regimented care) and the realities of routine care. These real-world results can complement traditional clinical trial data to help inform and optimize clinical treatment decisions.

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