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NSCLC, metastatic 1

2356 - Phase 2 study of ceritinib in ALKi-naïve patients (pts) with ALK-rearranged (ALK+) non-small cell lung cancer (NSCLC): Whole body responses in the overall pt group and in pts with baseline brain metastases (BM)


09 Oct 2016


NSCLC, metastatic 1


Enriqueta Felip


Annals of Oncology (2016) 27 (6): 416-454. 10.1093/annonc/mdw383


E. Felip1, S. Orlov2, K. Park3, C. Yu4, C. Tsai5, M. Nishio6, M.C. Dols7, M. McKeage8, W. Su9, T.S.K. Mok10, G. Scagliotti11, D.R. Spigel12, V.Q. Passos13, V. Chen13, F. Munarini14, A. Shaw15

Author affiliations

  • 1 Medical Oncology, Vall d`Hebron University Hospital Institut d'Oncologia, 08035 - Barcelona/ES
  • 2 Thoracic Oncology, Saint Petersburg State Pavlov Medical University, St-Petersburg/RU
  • 3 Hematology/oncology, Innovative Cancer Medicine Institute, Seoul/KR
  • 4 Internal Medicine, National Taiwan University College of Medicine, Taipei/TW
  • 5 Thoracic Oncology, Taipei Veterans General Hospital, Taipei/TW
  • 6 Thoracic Medical Oncology, Cancer Institute Hospital of JFCR, Tokyo/JP
  • 7 Medical Oncology, Hospital Universitario Málaga General Carlos Haya, Malaga/ES
  • 8 Clinical Pharmacology, University of Auckland, Auckland/NZ
  • 9 Internal Medicine, National Cheng Kung University Hospital, Tainan/TW
  • 10 Clinical Oncology, Chinese University of Hong Kong, Hong Kong/CN
  • 11 Oncology, University of Torino, Orbassano/IT
  • 12 Medical Oncology, Sarah Cannon Research Institute, Nashville/US
  • 13 Oncology, Novartis Pharmaceuticals Corporation, East Hanover/US
  • 14 Oncology Clinical Development, Novartis Pharma AG, Basel/CH
  • 15 Cancer Center, Massachusetts General Hospital, Boston/US


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Abstract 2356


In the pivotal ASCEND-1 study, ceritinib showed whole body efficacy in ALKi-naïve pts with ALK+ NSCLC (including those with baseline BM), most of whom had received multiple prior therapies; median progression-free survival (mPFS) was 18.4 mo. The ASCEND-3 single-arm, open-label multicentre study evaluated the efficacy and safety of ceritinib in previously treated ALKi-naïve pts with ALK+ NSCLC (NCT01685138).


Pts enrolled worldwide received oral ceritinib 750 mg/d (fasted) from 21 Jan 2013. Whole body efficacy was assessed by investigator (inv) and by Blinded Independent Review Committee (BIRC). Prior chemotherapy (≤3 lines) was permitted. Data cutoff was 15 Nov 2015.


Of 124 pts receiving ceritinib, 122 (98.4%) had received prior antineoplastic regimens (with 31 [25%] receiving ≥3). Of the 124 pts, 49 (39.5%) had baseline BM. Median time from diagnosis to initiation of ceritinib was 13.5 mo (range 1.0–283.1); median duration of exposure was 22.5 mo (range 0.1–32.8); median follow-up was 23.1 mo (range 0.6–32.8). mPFS was 16.6 mo (95% CI 11.0, 22.1) by inv, and 18.4 mo (95% CI 10.9, 26.3) by BIRC. The table shows efficacy in all pts, and in pts by baseline BM status. The most frequently reported AEs were gastrointestinal (GI): diarrhoea (85.5%), nausea (77.4%) and vomiting (71.8%). Most GI AEs were Grade 1/2. Grade 3/4 diarrhoea, nausea and vomiting occurred in 3.2%, 6.5% and 6.5% of pts, respectively. Overall, 11.3% of pts discontinued due to AEs, with no particular AE predominating.


Consistent with ASCEND-1, ceritinib resulted in a durable mPFS of 16.6/18.4 mo by inv/BIRC in ALKi-naïve pts with ALK+ NSCLC, of whom 54.8% had received ≥2 prior antineoplastic regimens. Whole body response rates were robust, irrespective of the presence of baseline BM. No new safety signals were identified in this study.

Clinical trial identification


Legal entity responsible for the study

Novartis Pharmaceutical Corporation


Novartis Pharmaceutical Corporation

All patients N = 124
By Investigator
ORR (CR + PR), n (%) [95% CI] 84 (67.7) [58.8, 75.9]
DCR (CR + PR + SD + NCR/NPD), n (%) [95% CI] 112 (90.3) [83.7, 94.9]
Median DOR, mo [95% CI] 22.1 [14.8, NE]
Median PFS, mo [95% CI] 16.6 [11.0, 22.1]
Median OS, mo Estimated 12-month OS rate, % [95% CI] Not yet reached 85.1 [77.4, 90.4]
Median PFS, mo [95% CI] 18.4 [10.9, 26.3]
Patients separated by brain metastases status at study entry
With brain metastases (N = 49) Without brain metastases (N = 75)
By Investigator
ORR (CR + PR), n (%) [95% CI] 28 (57.1) [42.2, 71.2] 56 (74.7) [63.3, 84.0]
DCR (CR + PR + SD + NCR/NPD), n (%) [95% CI] 43 (87.8) [75.2, 95.4] 69 (92.0) [83.4, 97.0]
ORR (CR + PR), n (%) [95% CI] 31 (63.3) [48.3, 76.6] 48 (64.0) [52.1, 74.8]
DCR (CR + PR + SD + NCR/NPD), n (%) [95% CI] 41 (83.7) [70.3, 92.7] 66 (88.0) [78.4, 94.4]

BIRC, Blinded Independent Review Committee; CI, confidence interval; CR, complete response; DCR, disease control rate; DOR, duration of response; Inv, investigator; mo, months; NCR, non-CR; NPR, non-progressive disease; ORR, overall response rate; OS, overall survival; PFS, progression free survival; PR, partial response; SD, stable disease


E. Felip: Consulting fees: Boehringer Ingelheim, MSD, Eli Lilly, Roche, Pfizer Speaker fees: Astra Zeneca, BMS, Novartis. K. Park: Advisor/Consultant: AZ, BI, Clovis, Eli Lilly, Hanmi, KHK, Novartis, ONO, Roche. C-M. Tsai: Honoraria: AstraZeneca, Roche, Eli Lilly, BI, Pfizer, MSD Consulting: AstraZeneca, Roche, Eli Lilly, BI, Pfizer Research: AstraZeneca. M. Nishio: Research funding: Novartis, Ono Pharma, Chugai Pharma, BMS, TAIHO Pharma, Eli Lilly, Pfizer, Astellas Pharma, AZ Honoraria: Pfizer,BMS, Ono Pharma, Chugai Pharma, Eli Lilly, Taiho Pharma, AZ. T.S.K. Mok: Stock: Sanomics Ltd Honoraria & Research: AZ Roche/Genentech, Pfizer, Lilley, BI, Merck Serono, MSD, Jenssen, Clovis Oncology, BioMarin, GSK, Novartis, SFJ, Acta Biosciences, Vertex, Aveo, Biodesix, BMS, GeneDecode. G. Scagliotti: Honoraria: Eli Lilly, AZ, Pfizer, Roche, Clovis Oncology Consulting/advisory, Speaker fees: Eli Lilly Travel/accommodation/expenses: Bayer. D.R. Spigel: Consulting/Advisory: Novartis, Genentech Travel, accommodation, expenses: Novartis, Genentech, Pfizer. V.Q. Passos: Novartis employee; Novartis stocks. F. Munarini: I confirm having potential conflicts of interest as I am employee of the company Novartis Pharma AG, and own stock. A. Shaw: Honoraria: Novartis, Pfizer, Roche Consulting/advisory: Ariad, Daiichi-sankyo, EMD Serono, Genentech, Ignyta, Novartis, Pfizer, Roche, Taiho, Blueprint Medicine Research funding: Genentech /Roche, Pfizer. All other authors have declared no conflicts of interest.

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