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Войти в исследования JTO clinical and research reports · 2026
Brief Report: Reassessment of bTMB as a Predictive Biomarker in NSCLC Immunotherapy-A Reanalysis of OAK and POPLAR.
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Liu Jiaqian, Bo Na, Nana-Sinkam Patrick, Ding Ying
Аннотация
INTRODUCTION: Blood-based tumor mutational burden (bTMB) has been proposed as a potential biomarker for identifying patients with advanced NSCLC who may benefit from immunotherapy. Prior studies have primarily focused on the high-bTMB group, which may lead to an incomplete or misleading assessment of the predictive value of bTMB. In this study, we used data from the POPLAR (NCT01903993) and OAK (NCT02008227) trials to re-evaluate the predictive role of bTMB for immunotherapy response in advanced NSCLC by analyzing all patients with available bTMB measures and evaluating outcomes in both high- and low-bTMB groups.
METHODS: Patients with evaluable bTMB from the POPLAR and OAK trials were included. For each study, hazard ratios (HRs) for both progression-free survival (PFS) and overall survival (OS) were calculated separately for the high- and low-bTMB groups across a range of cut points.
RESULTS: A total of 211 and 583 patients with evaluable bTMB were included from the POPLAR and OAK trials, respectively. bTMB cut points from 4 to 26 (in increments of 2) were evaluated. At a cut point of 14, one of the evaluated thresholds, in POPLAR, patients with high bTMB had a PFS HR of 0.50 (95% confidence interval [CI]: 0.30-0.83) and an OS HR of 0.51 (95% CI: 0.30-0.86), whereas patients with low bTMB had a PFS HR of 1.23 (95% CI: 0.86-1.76) and an OS HR of 0.82 (95% CI: 0.55-1.21). In OAK, patients with high-bTMB had a PFS HR of 0.68 (95% CI: 0.50-0.91), and those with low bTMB had a PFS HR of 0.98 (95% CI: 0.79-1.12), with no difference between the two groups for OS (HR = 0.63, 95% CI: 0.45-0.88 versus HR = 0.63, 95% CI: 0.50-0.80).
CONCLUSIONS: The predictiveness of bTMB in identifying patients with NSCLC who may benefit from immunotherapy was evident for PFS but not for OS. Observing a differential treatment efficacy trend solely within the high-bTMB group across multiple cut points was insufficient to establish predictive utility. A valid assessment requires a comprehensive evaluation of both high- and low-bTMB populations, with predictiveness established by reporting differential treatment efficacy between these two groups.
METHODS: Patients with evaluable bTMB from the POPLAR and OAK trials were included. For each study, hazard ratios (HRs) for both progression-free survival (PFS) and overall survival (OS) were calculated separately for the high- and low-bTMB groups across a range of cut points.
RESULTS: A total of 211 and 583 patients with evaluable bTMB were included from the POPLAR and OAK trials, respectively. bTMB cut points from 4 to 26 (in increments of 2) were evaluated. At a cut point of 14, one of the evaluated thresholds, in POPLAR, patients with high bTMB had a PFS HR of 0.50 (95% confidence interval [CI]: 0.30-0.83) and an OS HR of 0.51 (95% CI: 0.30-0.86), whereas patients with low bTMB had a PFS HR of 1.23 (95% CI: 0.86-1.76) and an OS HR of 0.82 (95% CI: 0.55-1.21). In OAK, patients with high-bTMB had a PFS HR of 0.68 (95% CI: 0.50-0.91), and those with low bTMB had a PFS HR of 0.98 (95% CI: 0.79-1.12), with no difference between the two groups for OS (HR = 0.63, 95% CI: 0.45-0.88 versus HR = 0.63, 95% CI: 0.50-0.80).
CONCLUSIONS: The predictiveness of bTMB in identifying patients with NSCLC who may benefit from immunotherapy was evident for PFS but not for OS. Observing a differential treatment efficacy trend solely within the high-bTMB group across multiple cut points was insufficient to establish predictive utility. A valid assessment requires a comprehensive evaluation of both high- and low-bTMB populations, with predictiveness established by reporting differential treatment efficacy between these two groups.