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Poster Discussion session - NSCLC, metastatic 1

1727 - Primary efficacy and updated safety of ceritinib (450 mg or 600 mg) with food vs 750 mg fasted in ALK+ metastatic NSCLC ASCEND-8)


19 Oct 2018


Poster Discussion session - NSCLC, metastatic 1


Targeted Therapy

Tumour Site


Byoung Chul Cho


B.C. Cho1, R. Obermannova2, S.V. Orlov3, U. Batra4, S.L. Geater5, M. McKeage6, C. Yang7, P.E. Postmus8, G. de Castro9, S. Kim10, P. De Marchi11, G.B. Kanakasetty12, V. Sriuranpong13, P.J. Voon14, Y.Y. Lau15, F. Kiertsman16, V.Q. Passos17, Z. Chen18, R. Dziadziuszko19

Author affiliations

  • 1 Medical Oncology, Yonsei Cancer Center Yonsei University, 6273 - Seoul/KR
  • 2 Department Of Comprehensive Cancer Care, Masaryk Memorial Cancer Institute and School of Medicine, Masaryk University, Brno/CZ
  • 3 Oncology, Pavlov Medical University, St.Petersburg/RU
  • 4 Medical Oncology, Rajiv Gandhi Cancer Institute and Research Centre, Delhi/IN
  • 5 Internal Medicine, Prince of Songkla University, Songkhla/TH
  • 6 School Of Medical Sciences, University of Auckland, Auckland/NZ
  • 7 Thoracic Medicine, Chang Gung Memorial Hospital, Taoyuan/TW
  • 8 Respiratory Diesease, Leiden University Medical Center (LUMC), 2300 RC - Leiden/NL
  • 9 Clinical Oncology, Instituto do Cancer do Estado de Sao Paulo, Sao Paulo/BR
  • 10 Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul/KR
  • 11 Medical Oncology, Barretos Cancer Hospital, Barretos, SP/BR
  • 12 Medical Oncology, HCG Curie Centre of Oncology & Kidwai Memorial Institute of Oncology, Bengaluru/IN
  • 13 Division Of Medical Oncology, Department Of Medicine, Chulalongkorn University and The King Chulalongkorn Memorial Hospital, Bangkok/TH
  • 14 Department Of Radiotherapy And Oncology, Hospital Umum Sarawak, Kuching/MY
  • 15 Pk Sciences, Novartis Institutes for BioMedical Research, East Hanover/US
  • 16 Global Drug Development, Novartis Pharmaceuticals Corporation, East Hanover/US
  • 17 Oncology, Novartis Pharmaceuticals Corporation, East Hanover/US
  • 18 Biostatistics, Novartis Pharmaceuticals Corporation, East Hanover/US
  • 19 Oncology And Radiotherapy, Medical University of Gdansk, 80-211 - Gdansk/PL


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Abstract 1727


Previous PK analysis results from ASCEND-8 study (NCT02299505) showed that ceritinib 450 mg with food had comparable exposure and more favorable GI safety profile than ceritinib 750 mg fasted in patients (pts) with ALK+ NSCLC.


In this open-label, phase 1, 3-arm study, pts with treatment-naïve or pre-treated ALK+ advanced/metastatic NSCLC were randomized 1:1:1 to ceritinib 450 or 600 mg with food and 750 mg fasted, stratified by prior treatment and presence/absence of brain metastasis at screening. Key secondary endpoints were overall response rate (ORR) and duration of response, per BIRC using RECIST 1.1. Efficacy analysis was based on all treatment-naïve pts with ALK+ defined by IHC. Safety analysis was based on all pts who received ≥1 dose of study drug. Primary efficacy analysis and updated safety results are presented here (data cut off: 27 March 2018).


A total of 306 pts were randomized to ceritinib 450 mg fed (n=108) or 600 mg fed (n=87) or 750 mg fasted (n=111). Of those, 198 were treatment-naïve with ALK+ by IHC and were assessed for efficacy (450 mg fed [n=73], 600 mg fed [n=51], and 750 mg fasted [n=74]). Median duration of study follow up was 19.6 months (mo) (range, 4.2-35.3) in all randomized pts and 14.3 mo (range, 4.2-30.2) in treatment-naïve pts who were ALK+ by IHC. ORR by BIRC was 78.1% (95% CI, 66.9-86.9), 72.5% (95% CI, 58·3-84·1), and 75.7% (95% CI, 64.3-84.9) in the 450 mg fed, 600 mg fed and 750 mg fasted arms, respectively. Other efficacy results are shown in the table. The 450 mg fed arm, when compared to 600 mg fed and 750 mg fasted arms, showed highest median relative dose intensity (100% vs 78.5% vs 83.7%), lowest proportion of pts with dose reductions (24.1% vs 65.1% vs 60.9%), all grade GI toxicities (75.9% vs 82.6% vs 91.8%) and grade 3/4 GI toxicities (2.8% vs 8.1% vs 13.6%).

BIRC assessment

Ceritinib 450 mg fed

(N = 73)

Ceritinib 600 mg fed

(N = 51*)

Ceritinib 750 mg fasted

(N = 74)

Overall response rate, n (%)

(95% CI)

57 (78.1)


37 (72.5)


56 (75.7)


Disease control rate, n (%)

(95% CI)

66 (90.4)


48 (94.1)


67 (90.5)


Median duration of response (in
responders), months (95% CI)

Estimated 18-month event-free probability, % (95% CI)

M† = 57

NE (11.2-NE)

52.9 (30.9-70.8)

M† = 37

20.7 (15.8-NE)

61.1 (36.7-78.5)

M† = 56

15.4 (8.3-NE)

36.7 (14.5-59.4)

Median time to response, weeks

(95% CI)







Median progression-free survival, months (95% CI)

Estimated 18-month event-free probability, % (95% CI)

NE (11.8-NE)

50.8 (33.7-65.7)

17.0 (10.1-NE)

48.6 (30.7-64.3)

12.2 (8.2-NE)

40.9 (23.3-57.8)

*The 600 mg fed arm has a lower number of patients because, based on the primary pharmacokinetic analysis results, the 450 mg fed arm was considered the most favorable fed dose and enrollment to the ceritinib 600 mg dose with food was closed.

†M is the number of patients included in the duration of response analysis by BIRC analysis

BIRC, blinded independent review committee; NE, not estimable


Ceritinib 450 mg fed dose compared to 750 mg fasted showed consistent anti-tumor efficacy and improved GI tolerability in pts with ALK+ advanced NSCLC.

Clinical trial identification


Editorial Acknowledgement

We thank Shiva Krishna Rachamadugu, Novartis Healthcare Pvt. Ltd., for providing medical editorial assistance with this abstract

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