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doi: https://doi.org/10.4143/crt.2021.1571    [Accepted]
Efficacy and Safety of Ceritinib 450 mg/d With Food and 750 mg/d in Fasted State in Treatment-Naïve Patients With ALK+ Non-small Cell Lung Cancer: Results From the ASCEND-8 Asian Subgroup Analysis
Byoung Chul Cho1 , Dong-Wan Kim2, Ullas Batra3, Keunchil Park4, Sang-We Kim5, Cheng-Ta Yang6, Pei-Jye Voon7, Virote Sriuranpong8, K. Govind Babu9, Khalid Amin10, Yingbo Wang10, Paramita Sen11, Khemaies Slimane10, Sarayut Geater12
1Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Korea
2Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea
3Medical Oncology, Rajiv Gandhi Cancer Institute & Research Center, New Delhi, India
4Division of Hematology-Oncology, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
5Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
6Chang Gung Memorial Hospital and Chang Gung University, Taoyuan, Taiwan
7Hospital Umum Sarawak, Kuching, Malaysia
8Chulalongkorn University and The King Chulalongkorn Memorial Hospital, Bangkok, Thailand
9HCG Curie Center of Oncology and Kidwai Memorial Institute of Oncology, Bengaluru, India
10Novartis Pharma AG, Basel, Switzerland
11Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA
12Songklanagarind Hospital, Prince of Songkla University, Songkhla, Thailand
Correspondence  Byoung Chul Cho ,Tel: 82-2-2228-0880, Email: CBC1971@yuhs.ac
Received: December 8, 2021;  Accepted: March 24, 2022.  Published online: March 25, 2022.
Previous report from the ASCEND-8 trial showed consistent efficacy with less gastrointestinal (GI) toxicity in patients with anaplastic lymphoma kinase-rearranged (ALK+) advanced/metastatic non-small cell lung cancer (NSCLC) treated with ceritinib 450-mg with food compared with 750-mg fasted. In this subgroup analysis, we report outcomes in Asian patients of the ASCEND-8 trial.
Materials and Methods
Key efficacy endpoints were blinded independent review committee (BIRC)-assessed overall response rate (ORR) and duration of response (DOR) evaluated per RECIST v1.1. Other efficacy endpoints were investigator-assessed ORR and DOR; BIRC- and investigator-assessed progression-free survival (PFS) and disease control rate (DCR); overall survival (OS). Safety was evaluated by frequency and severity of adverse events.
At final data cut-off (6-March-2020), 198 treatment-naïve patients were included in efficacy analysis, of which 74 (37%) comprised the Asian subset; 450-mg fed (n=29), 600-mg fed (n=19) and 750-mg fasted (n=26). Baseline characteristics were mostly comparable across study arms. At baseline, more patients in 450-mg fed arm (44.8%) had brain metastases than in 750-mg fasted arm (26.9%). Per BIRC, patients in the 450-mg fed arm had a numerically higher ORR, 24-month DOR rate and 24-month PFS rate than the 750-mg fasted arm. The 36-month OS rate was 93.1% in 450-mg fed arm and 70.9% in 750-mg fasted arm. Any grade GI toxicity occurred in 82.8% and 96.2% of patients in the 450-mg fed and 750-mg fasted arms, respectively.
Asian patients with ALK+ advanced/metastatic NSCLC treated with ceritinib 450-mg fed showed numerically higher efficacy and lower GI toxicity than 750-mg fasted patients.
Key words: Ceritinib, NSCLC, ALK-activated, ALK-inhibitors
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