Robert C Doebele1, Laura Perez2, Huong Trinh3, Michael Martinec2, Reynaldo Martina4, Todd Riehl3, Matthew G Krebs5, Neal J Meropol6, William B Wong3, Gracy Crane7. 1. Anschutz Medical Campus, University of Colorado, 1665 Aurora Court Anschutz Cancer Pavilion, Aurora, CO 80045, USA. 2. F. Hoffmann-La Roche Ltd, Grenzacherstrasse 124, 4070, Basel, Switzerland. 3. Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080, USA. 4. Department of Biostatistics, University of Liverpool, Liverpool, L69 3BX, UK. 5. Division of Cancer Sciences, Faculty of Biology, Medicine & Health, The University of Manchester & The Christie NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, M20 4BX, UK. 6. Flatiron Health, Inc., 233 Spring Street, New York, NY 10013, USA. 7. F. Hoffmann-La Roche Ltd, Hexagon Place, Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, UK.
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.
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.
Entities:
Keywords:
NSCLC; comparative effectiveness; crizotinib; entrectinib; real-world data