RT Journal Article
T1 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.
A1 Nishio, Makoto
A1 Felip, Enriqueta
A1 Orlov, Sergey
A1 Park, Keunchil
A1 Yu, Chong-Jen
A1 Tsai, Chun-Ming
A1 Cobo, Manuel
A1 McKeage, Mark
A1 Su, Wu-Chou
A1 Mok, Tony
A1 Scagliotti, Giorgio V
A1 Spigel, David R
A1 Viraswami-Appanna, Kalyanee
A1 Chen, Zhe
A1 Passos, Vanessa Q
A1 Shaw, Alice T
K1 ALK
K1 Ceritinib
K1 NSCLC
K1 Phase II
AB 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. 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. 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. 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.
PB Elsevier
YR 2019
FD 2019-11-25
LK http://hdl.handle.net/10668/14760
UL http://hdl.handle.net/10668/14760
LA en
NO 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):609-617
DS RISalud
RD Apr 7, 2025