Abstract
Based on the results of the CheckMate 017 and CheckMate 057 studies, nivolumab therapy has become a new standard treatment for both squamous and non-squamous non-small-cell lung cancer (NSCLC). However, due to the specific inclusion criteria of these clinical trials, the efficacy and safety of nivolumab in real-world practice were not certain. In general, the real-world results of nivolumab treatment have been consistent with those obtained in clinical trials. Additional analyses of the real-world data have made the identification of prognostic factors possible. Good performance status is the most significant predictor of clinical benefit. Brain metastases, liver metastases, EGFR mutation, malignant pleural effusion, and a high number of metastatic sites were identified as negative prognostic factors. By contrast, a longer time to disease progression (>6 months) from the beginning of prior chemotherapy and an objective response to chemotherapy seem to have positive prognostic value in the case of nivolumab treatment. In terms of patient age, the data are inconclusive. Some blood biomarkers can also be considered significant prognostic factors.
Highlights
Immune checkpoint inhibitors targeting programmed death 1 (PD-1) and its ligand (PD-L1) have significantly changed the management of advanced non-small-cell lung cancer (NSCLC) in recent years [1]
Some real-world data concerning nivolumab have recently been published, including those derived from the Expanded Access Program (EAP) and post-registration studies
This paper aims to provide an overview of the selected real-world studies on nivolumab and to describe predictive factors of value in clinical practice
Summary
Immune checkpoint inhibitors targeting programmed death 1 (PD-1) and its ligand (PD-L1) have significantly changed the management of advanced non-small-cell lung cancer (NSCLC) in recent years [1]. Nivolumab was associated with significantly longer overall survival (OS) than docetaxel and had a good safety profile in squamous and non-squamous NSCLC in two pivotal phase III clinical trials (CheckMate 017 and CheckMate 057) [2,3]. Further real-world NSCLC population studies and evaluation of the value of nivolumab in clinical practice are necessary to select a subgroup of patients in whom clinical benefits are most likely. Some real-world data concerning nivolumab have recently been published, including those derived from the Expanded Access Program (EAP) and post-registration studies (data for nivolumab are more frequently published than data for atezolizumab and pembrolizumab). This paper aims to provide an overview of the selected real-world studies on nivolumab and to describe predictive factors of value in clinical practice
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