Comparative effectiveness analysis between entrectinib clinical trial and crizotinib real-world data in ROS1+ NSCLC
Publication: Journal of Comparative Effectiveness Research
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; 8.2 (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.
Supplementary Material
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Pages: 1271 - 1282
PubMed: 34427452
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© 2021 Laura Perez. This work is licensed under the Attribution-NonCommercial-NoDerivatives 4.0 Unported License
History
Received: 4 June 2021
Accepted: 9 August 2021
Published online: 24 August 2021
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F Hoffmann-La Roche Ltd
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Comparative effectiveness analysis between entrectinib clinical trial and crizotinib real-world data in ROS1+ NSCLC. (2021) Journal of Comparative Effectiveness Research. DOI: 10.2217/cer-2021-0131
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