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(Abstract)

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This document presents the results of a retrospective analysis conducted by the U.S. Food and Drug Administration (FDA) on the association between overall survival (OS) and the receipt of subsequent immune checkpoint inhibitors (ICI) in patients with metastatic non-small cell lung cancer (NSCLC).<br /><br />The analysis included data from 17 randomized controlled trials (RCTs) investigating ICI-based regimens for first-line treatment of metastatic NSCLC. The trials were divided into two groups: those that permitted on-study crossover from chemotherapy control arms to ICI-based arms, and those that did not permit crossover.<br /><br />The results showed that in RCTs that permitted on-study crossover, 31-65% of control arm patients received subsequent ICI therapy. In RCTs that did not permit crossover, 6.5-46% of control arm patients received subsequent ICI therapy. However, the correlations presented in the analysis are exploratory and hypothesis-generating.<br /><br />The authors conclude that substantial proportions of patients in chemotherapy control arms of most ICI-based RCTs for first-line treatment of metastatic NSCLC received subsequent ICI therapy, regardless of whether on-study crossover was permitted. They suggest that permitting on-study crossover may not impact the analysis of OS in these trials.<br /><br />Future analyses using patient-level data will further examine the association between the treatment effect of ICI-based regimens compared to control arm followed by subsequent ICI therapy on OS, taking into account important clinical factors.<br /><br />In summary, this analysis provides preliminary evidence that many patients in chemotherapy control arms of first-line ICI-based RCTs for metastatic NSCLC receive subsequent ICI therapy, regardless of whether crossover is permitted. The results suggest that permitting crossover may not affect the analysis of OS in these trials. Further research using patient-level data is needed to confirm these findings and explore other clinical factors.

Asset Subtitle

Oladimeji Akinboro

Meta Tag

Speaker Oladimeji Akinboro

Topic Metastatic NSCLC: Immunotherapy - Retrospective

Keywords

retrospective analysis

U.S. Food and Drug Administration

association

overall survival

immune checkpoint inhibitors

metastatic non-small cell lung cancer

randomized controlled trials

chemotherapy control arms

on-study crossover

patient-level data