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Comparative effectiveness analysis between entrectinib clinical trial and crizotinib real-world data in ROS1+ NSCLC
Doebele, R. C. Perez, L. Trinh, H. Martinec, M. Martina, R. Riehl, T. Krebs, Matthew G Meropol, N. J. Wong, W B Crane, G.
Doebele, R. C.
Perez, L.
Trinh, H.
Martinec, M.
Martina, R.
Riehl, T.
Krebs, Matthew G
Meropol, N. J.
Wong, W B
Crane, G.
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Abstract
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; 8.8 (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 (15.1-19.9) months. Conclusion: Entrectinib administered in clinical trials may be associated with longer TTD than a real-world crizotinib population.
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Date
2021
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Article
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Doebele RC, Perez L, Trinh H, Martinec M, Martina R, Riehl T, et al. Comparative effectiveness analysis between entrectinib clinical trial and crizotinib real-world data in ROS1+ NSCLC. Journal of Comparative Effectiveness Research. 2021 Aug 24.