2026-04-13T06:37:14Zhttps://recercat.cat/oai/request

oai:recercat.cat:11351/64972025-10-04T05:19:32Zcom_2072_378070com_2072_378040col_2072_378092

Final Overall Survival and Other Efficacy and Safety Results From ASCEND-3: Phase II Study of Ceritinib in ALKi-Naive Patients With ALK-Rearranged NSCLC Orlov, Sergey Park, Keunchil Yu, Chong-Jen Tsai, Chun-Ming Felip Font, Enriqueta Nishio, Makoto Institut Català de la Salut [Nishio M] Thoracic Medical Oncology Department, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan. [Felip E] Servei d’Oncologia Mèdica, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. [Orlov S] Department of Thoracic Oncology, Pavlov First Saint Petersburg State Medical University, St. Petersburg, Russia. [Park K] Division of Hematology and Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. [Yu CJ] Department of Internal Medicine, National Taiwan University, Taipei, Taiwan. [Tsai CM] Department of Oncology, Taipei Veterans General Hospital, Taipei, Taiwan Vall d'Hebron Barcelona Hospital Campus Pulmons - Càncer - Quimioteràpia Avaluació de resultats (Assistència sanitària) DISEASES::Neoplasms::Neoplasms by Site::Thoracic Neoplasms::Respiratory Tract Neoplasms::Lung Neoplasms Other subheadings::Other subheadings::Other subheadings::/drug therapy ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Diagnosis::Prognosis::Treatment Outcome ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias torácicas::neoplasias del tracto respiratorio::neoplasias pulmonares Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::diagnóstico::pronóstico::resultado del tratamiento Ceritinib; NSCLC; Fase II Ceritinib; NSCLC; Fase II Ceritinib; NSCLC; Phase II Introduction The phase II, single-arm ASCEND-3 study assessed the efficacy and safety of ceritinib in anaplastic lymphoma kinase (ALK) inhibitor (ALKi)–naive patients with ALK-rearranged NSCLC who had received at least three previous lines of chemotherapy. Here, we report the final efficacy and safety results. Methods Eligible patients (including those with asymptomatic or neurologically stable brain metastases) received oral ceritinib (750 mg/day, fasted). The primary end point was investigator-assessed overall response rate (ORR). Secondary end points were Blinded Independent Review Committee–assessed ORR; investigator- and Blinded Independent Review Committee–assessed overall intracranial response rate, duration of response, time to response, disease control rate, and progression-free survival (PFS); overall survival (OS); and safety. Exploratory end points included patient-reported outcomes. Results Of the 124 patients enrolled, 122 (98.4%) had received previous antineoplastic medications (31 patients [25.0%] received at least three regimens), and 49 (39.5%) had baseline brain metastases. The median follow-up time (data cutoff: January 22, 2018) was 52.1 (range, 48.4–60.1) months. The investigator-assessed ORR was 67.7% (95% confidence interval [CI]: 58.8–75.9), and the median PFS was 16.6 months (95% CI: 11.0–23.2). The median OS was 51.3 months (95% CI: 42.7–55.3). Most common adverse events (all grades, ≥60% of patients, all-causality) were diarrhea (85.5%), nausea (78.2%), and vomiting (71.8%). Overall, 18 patients (14.5%) had an adverse event leading to treatment discontinuation. Health-related quality of life was maintained during ceritinib treatment. Conclusions Ceritinib exhibited prolonged and clinically meaningful OS, PFS, and duration of response in chemotherapy-pretreated (at least three lines), ALKi-naive patients with ALK+ NSCLC. The safety profile was consistent with that reported in previous studies. 2021-11-04T13:34:42Z 2021-11-04T13:34:42Z 2019 2020-04 info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion Nishio M, Felip E, Orlov S, Park K, Yu CJ, Tsai CM, et al. Final Overall Survival and Other Efficacy and Safety Results From ASCEND-3: Phase II Study of Ceritinib in ALKi-Naive Patients With ALK-Rearranged NSCLC. J Thorac Oncol. 2020 Apr;15(4):609–17. 1556-1380 https://hdl.handle.net/11351/6497 10.1016/j.jtho.2019.11.006 31778798 000522855800023 eng Journal of Thoracic Oncology;15(4) https://doi.org/10.1016/j.jtho.2019.11.006 Attribution-NonCommercial-NoDerivatives 4.0 International http://creativecommons.org/licenses/by-nc-nd/4.0/ info:eu-repo/semantics/openAccess application/pdf application/pdf application/pdf application/pdf application/pdf application/pdf application/pdf Elsevier Scientia