Overall Survival Results of Ceritinib in ALKi-Naïve Patients with ALK-Rearranged NSCLC (ASCEND-3)
Invited conference paper presented and published in conference proceedings


摘要Background: The previous analysis of phase 2, ASCEND-3 study (NCT01685138; data cutoff: November 15, 2015) demonstrated prolonged median progression-free survival (mPFS) with ceritinib 750 mg/d (fasted) in ALKi-naïve patients with ALK+ NSCLC, who had received ≤3 prior lines of chemotherapy. The current analysis (data cutoff: January 22, 2018) from ASCEND-3 study reports the final safety and efficacy results including overall survival (OS).

Methods: ASCEND-3 is a multicenter, single-arm, open-label, phase 2 study in ALKi-naïve patients (aged, ≥18 years) with locally advanced or metastatic ALK+ NSCLC, who had received ≤3 lines of chemotherapy. Patients received oral ceritinib 750 mg/d (fasted). Primary endpoint was overall response rate (ORR) per RECIST v1.1 (by investigator). Secondary endpoints were ORR (by blinded independent review committee [BIRC]); overall intracranial response rate (OIRR), duration of response (DOR), disease control rate (DCR), PFS (by investigator and BIRC); OS; and safety.

Results: Of 124 ceritinib-treated patients, 123 (99.2%) had received prior antineoplastic regimens (31 patients [25.0%], ≥3 regimens), and 49 (39.5%) had baseline brain metastases. Median follow-up time was 52.14 months (range, 48.4-60.1). Median duration of drug exposure was 23.2 months (range, 0.1-55.2). Median OS was 51.3 months (95% CI: 42.7, 55.3). Other efficacy results are shown in the table below. The most common adverse events (AEs [all grades], ≥60% of patients), suspected to be drug related, were diarrhea (83.1%), nausea (76.6%), and vomiting (69.4%). Grade 3/4 AEs suspected to be drug related were reported in 81 patients (65.3%). Overall, 18 patients (14.5%) had an AE leading to treatment discontinuation.

Conclusions: Ceritinib demonstrated prolonged and clinically meaningful OS, PFS, and DOR in chemotherapy pretreated (≤3 lines), ALKi-naïve patients with ALK+ NSCLC. The safety profile is consistent with the previous studies.

Clinical trial identification: NCT01685138.
著者E Felip, M Nishio, S Orlov, K Park, C-J Yu, C-M Tsai, M Cobo, M McKeage, W-C Su, T SK Mok, G V Scagliotti, D Spigel, V Q Passos, Z Chen, A T Shaw
會議名稱43rd ESMO Congress (ESMO)
會議論文集題名Annals of Oncology
系列標題Poster Discussion
叢書冊次Abst: LBA57
期次Suppl 8
頁次745 - 745

上次更新時間 2020-05-08 於 00:53