Supplementary materials: Comparative effectiveness analysis between entrectinib clinical trial and crizotinib real-world data in <i>ROS1+</i> NSCLC

<b>These are supplementary materials for the article '</b><b>Comparative effectiveness analysis between entrectinib clinical trial and crizotinib real-world data in </b><b><i>ROS1+</i></b><b> NSCLC</b><b>' published in the</b><b><i> Journal of Comparative Effectiveness Research</i></b><b>.</b><b>Supplementary Materials</b>o Censoringo Statistical methodso Sensitivity analyseso Unadjusted resultso Propensity score<b>Supplementary Table 1. </b>Censoring rules for TTD, PFS, and OS.<b>Supplementary Table 2.</b> Propensity score matching.<b>Supplementary Table 3. </b>Comparison of results of the Cox pro-portional hazard model using BICR or investigator-assessed progression in the trial.<b>Supplementary Table 4. </b>Landmark analyses at 1 and 3 months for TTD and PFS.<b>Supplementary Table 5. </b>Sensitivity analysis of the TTD.<b>Supplementary Table 6.</b> Subgroup analysis by CNS status: unad-justed TTD and PFS.<b>Supplementary Table 7.</b> Multivariate Cox model of treatment effect by CNS status.<b>Supplementary Figure 1. </b>Swimmer plot of patients receiving treatment beyond progression (TBP) in the crizotinib cohort (37 out of 65 patients received TBP).<b>Summary: </b><b>Aim:</b> Generating direct comparative evidence in prospective randomized trials is difficult for rare diseases. Real-world cohorts may supplement control populations. <b>Methods:</b> Entrectinib-treated adults with advanced <i>ROS1</i> fusion-positive NSCLC (n = 94) from Phase I/II trials (ALKA-372-001 [EudraCT2012-00148-88], STARTRK-1 [NCT02097810], and STARTRK-2 [NCT02568267]) were compared with a real-world crizotinib-treated cohort (n = 65). Primary end point, time-to-treatment discontinuation (TTD); secondary end points, PFS and OS. <b>Results:</b> Median (95% CI) weighted TTD: 12.9 (9.9–17.4) months for entrectinib; 8.2 (6.2–9.9) months for crizotinib (weighted hazard ratio: 0.72 [0.51–1.02]). Median OS with entrectinib was not reached, weighted median OS with crizotinib was 18.5 (15.1–47.2) months. <b>Conclusion:</b> Entrectinib administered in clinical trials may be associated with longer TTD than a real-world crizotinib population.