2023 World Conference on Lung Cancer (Posters)-P2.07. Association between OS and Subsequent ICI in Control Arm Patients of First Line ICI-based RCTs of Advanced/Metastatic NSCLC: FDA Analysis

P2.07. Association between OS and Subsequent ICI in Control Arm Patients of First Line ICI-based RCTs of Advanced/Metastatic NSCLC: FDA Analysis - PDF(Slides)

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Several trials have shown that anti-PD-(L)1-based immune checkpoint inhibitor (ICI) regimens, alone or in combination with chemotherapy, can improve overall survival (OS) in patients with advanced non-small cell lung cancer (NSCLC). However, many trials evaluating ICI-based regimens do not allow patients in the chemotherapy control group to switch to the ICI arm. This study aimed to evaluate the potential effect of crossover on OS in first-line trials evaluating ICI-based regimens in NSCLC.<br /><br />Data was collected from the clinical study reports of all relevant trials submitted to the FDA. The key data elements extracted from each trial included the type of investigational regimen, whether on-study crossover was allowed, the rate of on-study crossover, the rate of subsequent receipt of ICI therapy by patients in the control arm, median OS, and OS hazard ratios.<br /><br />The results showed that a substantial proportion of patients in the chemotherapy control arms of most trials received subsequent ICI therapy, regardless of whether on-study crossover was permitted. The analysis suggested that permitting on-study crossover in these trials may not have an impact on OS outcomes in the control group.<br /><br />However, it is important to note that the analysis was limited to trials included in marketing applications submitted to the FDA, and caution should be exercised when generalizing the findings to other tumor types.<br /><br />In conclusion, this study suggests that permitting on-study crossover in first-line trials evaluating ICI-based regimens for NSCLC may not have a significant effect on OS outcomes in the control group. Future analyses using patient-level data will further investigate the association between treatment effect and subsequent ICI therapy on OS, adjusting for relevant clinical factors.

Asset Subtitle

Oladimeji Akinboro

Meta Tag

Speaker Oladimeji Akinboro

Topic Metastatic NSCLC: Immunotherapy - Retrospective

Keywords

anti-PD-(L)1-based immune checkpoint inhibitor

ICI regimens

chemotherapy

overall survival

non-small cell lung cancer

on-study crossover

investigational regimen

FDA

OS hazard ratios

tumor types