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dc.contributor.authorKrebs, Matthew G
dc.contributor.authorDe Braud, F.
dc.contributor.authorSiena, S.
dc.contributor.authorDrilon, A.
dc.contributor.authorDoebele, R. C.
dc.contributor.authorPatel, M. R.
dc.contributor.authorCho, B. C.
dc.contributor.authorLiu, S. V.
dc.contributor.authorAhn, M. J.
dc.contributor.authorChiu, C. H.
dc.contributor.authorFarago, A. F.
dc.contributor.authorLin, C. C.
dc.contributor.authorKarapetis, C. S.
dc.contributor.authorLi, Y. C.
dc.contributor.authorBarlesi, F.
dc.contributor.authorSimmons, B.
dc.contributor.authorPitcher, B.
dc.contributor.authorDziadziuszko, R.
dc.date.accessioned2020-12-08T05:36:28Z
dc.date.available2020-12-08T05:36:28Z
dc.date.issued2020en
dc.identifier.citationKrebs MG, De Braud F, Siena S, Drilon A, Doebele RC, Patel MR, et al. 1287P Efficacy and safety of entrectinib in locally advanced/metastatic ROS1 fusion-positive NSCLC: An updated integrated analysis. Annals of Oncology. 2020;31:S831-S3.en
dc.identifier.doi10.1016/j.annonc.2020.08.1601en
dc.identifier.urihttp://hdl.handle.net/10541/623474
dc.description.abstractBackground: Entrectinib is a potent, selective, CNS active, ROS1 tyrosine kinase inhibitor (TKI). In a preliminary analysis (data cut-off: 31 May 2018) of pts with ROS1 fusion-positive (ROS1-fp) NSCLC enrolled in phase 1/2 studies (ALKA-372-001, STARTRK-1, STARTRK-2; EudraCT 2012-000148-88, NCT02097810, NCT02568267), treatment with entrectinib produced clinically meaningful and durable systemic responses with a manageable safety profile. We report on an updated integrated analysis in a larger patient population with longer follow-up (data cut-off: 1 May 2019). Methods: Enrolled pts were ROS1 TKI naïve with measurable disease; most received entrectinib 600mg once daily. Tumours were assessed by blinded independent central review using RECIST v1.1, after 4 wks and every 8 wks thereafter. Primary endpoints were objective response rate (ORR) and duration of response (DoR). Progression-free survival (PFS), overall survival (OS), efficacy in pts with/without baseline CNS metastases, and safety were also assessed. Results: The efficacy-evaluable population comprised 161 pts with ROS1-fp NSCLC; baseline characteristics are shown (Table). Median follow-up: 15.8 months (range 0.1e43.2). ORR, 67.1% (95% CI 59.3e74.3); 14 pts (8.7%) achieved complete response, 94 (58.4%) partial response, 14 (8.7%) stable disease, 15 (9.3%) disease progression. Median DoR, 15.7 months (95% CI 13.9e28.6); median PFS, 15.7 months (95% CI 11.0e21.1); median OS, not estimable (NE) (95% CI 28.3eNE). In the subgroup with prior immunotherapy (n¼24), ORR, 70.8% (95% CI 48.9e87.4). In pts with investigator-assessed CNS metastases at baseline, ORR, 62.5% (95% CI 48.6e75.1). The safety profile was similar to that previously reported. Conclusions: This updated analysis, using a larger dataset with longer follow-up, shows that entrectinib induces clinically meaningful responses in pts with ROS1-fp NSCLC, including pts with CNS metastases at baseline.en
dc.language.isoenen
dc.relation.urlhttps://dx.doi.org/10.1016/j.annonc.2020.08.1601en
dc.titleEfficacy and safety of entrectinib in locally advanced/metastatic ROS1 fusion-positive NSCLC: An updated integrated analysisen
dc.typeMeetings and Proceedingsen
dc.contributor.departmentDivision of Cancer Sciences, The University of Manchester and The Christie NHS Foundation Trust, Manchester,en
dc.identifier.journalAnnals of Oncologyen
dc.description.noteen]
refterms.dateFOA2020-12-08T11:08:54Z


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