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

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posted on 2024-01-03, 15:59 authored by Robert C. Doebele, Laura Perez, Huong Trinh, Michael Martinec, Reynaldo Martina, Todd Riehl, Matthew G. Krebs, Neal J Meropol, William B Wong, Gracy Crane

These are supplementary materials for the article 'Comparative effectiveness analysis between entrectinib clinical trial and crizotinib real-world data in ROS1+ NSCLC' published in the Journal of Comparative Effectiveness Research.<ul><li>Supplementary Materials</li><li>o Censoring</li><li>o Statistical methods</li><li>o Sensitivity analyses</li><li>o Unadjusted results</li><li>o Propensity score</li><li>Supplementary Table 1. Censoring rules for TTD, PFS, and OS.</li><li>Supplementary Table 2. Propensity score matching.</li><li>Supplementary Table 3. Comparison of results of the Cox pro-portional hazard model using BICR or investigator-assessed progression in the trial.</li><li>Supplementary Table 4. Landmark analyses at 1 and 3 months for TTD and PFS.</li><li>Supplementary Table 5. Sensitivity analysis of the TTD.</li><li>Supplementary Table 6. Subgroup analysis by CNS status: unad-justed TTD and PFS.</li><li>Supplementary Table 7. Multivariate Cox model of treatment effect by CNS status.</li><li>Supplementary Figure 1. Swimmer plot of patients receiving treatment beyond progression (TBP) in the crizotinib cohort (37 out of 65 patients received TBP).</li></ul>Summary: Aim: Generating direct comparative evidence in prospective randomized trials is difficult for rare diseases. Real-world cohorts may supplement control populations. Methods: Entrectinib-treated adults with advanced ROS1 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. Results: 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. Conclusion: Entrectinib administered in clinical trials may be associated with longer TTD than a real-world crizotinib population.