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Efficacy and Safety of Ceritinib 450 mg/day with Food and 750 mg/day in Fasted State in Treatment-Naïve Patients with ALK+ Non-Small Cell Lung Cancer: Results from the ASCEND-8 Asian Subgroup Analysis

Cho BC 1 , Kim DW 2 , Batra U 3 , Park K 4 , Kim SW 5 , Yang CT 6 Show all authors , Voon PJ 7 , Sriuranpong V 8 , Babu KG 9 , Amin K 10 , Wang Y 10 , Sen P 11 , Slimane K 10 , Geater S 12

Affiliations 

  • 1 Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Korea
  • 2 Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea
  • 3 Medical Oncology, Rajiv Gandhi Cancer Institute and Research Center, New Delhi, India
  • 4 Division of Hematology-Oncology, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
  • 5 Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
  • 6 Chang Gung Memorial Hospital and Chang Gung University, Taoyuan, Taiwan
  • 7 Hospital Umum Sarawak, Kuching, Malaysia
  • 8 Chulalongkorn University and The King Chulalongkorn Memorial Hospital, Bangkok, Thailand
  • 9 HCG Curie Center of Oncology and Kidwai Memorial Institute of Oncology, Bengaluru, India
  • 10 Novartis Pharma AG, Basel, Switzerland
  • 11 Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA
  • 12 Songklanagarind Hospital, Prince of Songkla University, Songkhla, Thailand
Cancer Res Treat, 2023 Jan;55(1):83-93.
PMID: 35344649 DOI: 10.4143/crt.2021.1571

Abstract

PURPOSE: 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 Response Evaluation Criteria in Solid Tumors v1.1. Other efficacy endpoints were investigator-assessed ORR and DOR; BIRC- and investigator-assessed progression-free survival (PFS) and disease control rate; overall survival (OS). Safety was evaluated by frequency and severity of adverse events.

RESULTS: At final data cutoff (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.

CONCLUSION: 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.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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