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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

김동완|박근칠|김상위|조병철|Ullas Batra|Cheng-Ta Yang|Pei-Jye Voon|Virote Sriuranpong|K. Govind Babu|Khalid Amin|Yingbo Wang|Paramita Sen|Khemaies Slimane|Sarayut Geater
대한암학회 (Korean Cancer Association)|2023.01|Cancer Research and Treatment|제55권 제1호|pp. 83-93|DOI 10.4143/crt.2021.1571

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키워드

Non-small-cell lung carcinomaCeritinibALK-activatedALK-inhibitors
주제분류의학일반

초록

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.

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.

참고문헌 (25)

  1. Soda M, "Identification of the transforming EML4-ALK fusion gene in non-small-cell lung cancer", Nature, 448, pp.561~566 (2007)
  2. Solomon BJ, "First-line crizotinib versus chemotherapy in ALK-positive lung cancer", N Engl J Med, 371, pp.2167~2177 (2014)
  3. Soria JC, "First-line ceritinib versus platinum-based chemotherapy in advanced ALK-rearranged non-small-cell lung cancer(ASCEND-4) : a randomised, open-label, phase 3 study", Lancet, 389, pp.917~929 (2017)
  4. "Xalkori prescribing information" (2017)[URL]
  5. "Zykadia prescribing information" (2019)[URL]
  6. Gristina V, "The emerging therapeutic landscape of ALK inhibitors in non-small cell lung cancer", Pharmaceuticals(Basel), 13, pp.474~ (2020)
  7. "FDA broadens ceritinib indication to previously untreated ALK-positive metastatic NSCLC" (2017)[URL]
  8. Shaw AT, "Ceritinib versus chemotherapy in patients with ALK-rearranged non-small-cell lung cancer previously given chemotherapy and crizotinib(ASCEND-5) : a randomised, controlled, open-label, phase 3 trial", Lancet Oncol, 18, pp.874~886 (2017)
  9. Crino L, "Multicenter phase II study of whole-body and intracranial activity with ceritinib in patients with ALK-rearranged non-small-cell lung cancer previously treated with chemotherapy and crizotinib : results from ASCEND-2", J Clin Oncol, 34, pp.2866~2873 (2016)
  10. Kim DW, "Activity and safety of ceritinib in patients with ALK-rearranged non-small-cell lung cancer(ASCEND-1) : updated results from the multicentre, open-label, phase 1 trial", Lancet Oncol, 17, pp.452~463 (2016)
  11. Cho BC, "ASCEND-8 : a randomized phase 1 study of ceritinib, 450 mg or 600 mg, taken with a low-fat meal versus 750 mg in fasted state in patients with snaplastic lymphoma kinase(ALK)-rearranged metastatic non-small cell lung cancer(NSCLC)", J Thorac Oncol, 12, pp.1357~1367 (2017)
  12. Cho BC, "Efficacy and safety of ceritinib(450 mg", d or 600 mg, d fasted in patients with ALK receptor tyrosine kinase(ALK)-positive NSCLC : primary efficacy results from the ASCEND-8 study, pp.J Thorac Oncol, 2019[DOI]
  13. Tan DS, "Ceri-tinib efficacy and safety in treatment-naive Asian patients with advanced ALK-rearranged NSCLC : an ASCEND-4 subgroup analysis", JTO Clin Res Rep, 2, pp.100131~ (2021)
  14. Zhou C, "Alectinib versus crizotinib in untreated Asian patients with anaplastic lymphoma kinase-positive non-small-cell lung cancer(ALESIA) : a randomised phase 3 study", Lancet Respir Med, 7, pp.437~446 (2019)
  15. Mok TS, "Alectinib(ALC)vs crizotinib(CRZ)in treatment-naïve ALK+ non-small-cell lung cancer(NSCLC) : Asian vs non-Asian subgroup analysis of the ALEX study", Ann Oncol, 28(Suppl 10), pp.X191~ (2017)
  16. Makoto Nishio, "Crizotinib versus Chemotherapy in Asian Patients with ALK-Positive Advanced Non-small Cell Lung Cancer", Cancer Research and Treatment, 50(3), pp.691~700 (2018), 대한암학회
  17. Wu YL, "Results of PROFILE 1029, a phase III comparison of first-line crizotinib versus chemotherapy in East Asian patients with ALK-positive advanced non-small cell lung cancer", J Thorac Oncol, 13, pp.1539~1548 (2018)
  18. Mok T, "Updated overall survival and final progression-free survival data for patients with treatment-naive advanced ALK-positive non-small-cell lung cancer in the ALEX study", Ann Oncol, 31, pp.1056~1064 (2020)
  19. Li H, "Cost effectiveness of ceritinib and alectinib versus crizotinib in first-line anaplastic lymphoma kinase-positive advanced non-small-cell lung cancer", Clin Drug Investig, 40, pp.183~189 (2020)
  20. Gainor JF, "The central nervous system as a sanctuary site in ALK-positive non-small-cell lung cancer", J Thorac Oncol, 8, pp.1570~1573 (2013)
  21. Ali A, "Survival of patients with non-small-cell lung cancer after a diagnosis of brain metastases", Curr Oncol, 20, pp.e300~6 (2013)
  22. Gaspar LE, "Time from treatment to subsequent diagnosis of brain metastases in stage III non-small-cell lung cancer : a retrospective review by the Southwest Oncology Group", J Clin Oncol, 23, pp.2955~2961 (2005)
  23. Lee SJ, "Leptomeningeal carcinomatosis in non-small-cell lung cancer patients : impact on survival and correlated prognostic factors", J Thorac Oncol, 8, pp.185~191 (2013)
  24. Sperduto PW, "Summary report on the graded prognostic assessment : an accurate and facile diagnosis-specific tool to estimate survival for patients with brain metastases", J Clin Oncol, 30, pp.419~425 (2012)
  25. Chow LQ, "Results of the ASCEND-7 phase II study evaluating ALK inhibitor(ALKi)ceritinib in patients(pts)with ALK+ non-small cell lung cancer(NSCLC)metastatic to the brain", Ann Oncol, 30(Suppl 5), pp.v602~60 (2019)

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