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Poster Display session 1

3300 - First-line ceritinib versus chemotherapy in patients (pts) with advanced ALK rearranged (ALK+) non-small cell lung cancer (NSCLC): ASCEND-4 Asian subgroup analysis

Date

28 Sep 2019

Session

Poster Display session 1

Topics

Tumour Site

Non-Small Cell Lung Cancer

Presenters

Daniel SW Tan

Citation

Annals of Oncology (2019) 30 (suppl_5): v591-v601. 10.1093/annonc/mdz259

Authors

D.S. Tan1, S. Geater2, C.J. Yu3, C.M. Tsai4, T.C. Hsia5, J. Zhou6, J. Chen7, M.C. Lin8, P. Yu9, J. He10, W. Li11, Y. Lu12, V. Sriuranpong13, C.T. Yang14, P. Sen15, F. Branle16, M. Shi17, Y.L. Wu18

Author affiliations

  • 1 Medical Oncology, National Cancer Centre Singapore, 169610 - Singapore/SG
  • 2 Internal Medicine, Songklanagarind Hospital, 90110 - Hat Yai, Songkhla/TH
  • 3 Internal Medicine, National Taiwan University Hospital, Taipei/TW
  • 4 Department Of Oncology, Taipei Veterans General Hospital, Taipei/TW
  • 5 Internal Medicine, China Medical University Hospital, Taichung/TW
  • 6 Department Of Respiratory Disease, Thoracic Disease Center, The First Affiliated Hospital, Zhejiang University, Hangzhou/CN
  • 7 Department Of Lung Cancer Surgery, General Hospital of Tianjin Medical University, Tianjin/CN
  • 8 Division Of Pulmonary And Critical Care Medicine, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung/TW
  • 9 Internal Medicine Oncology, Sichuan Province Cancer Hospital, Chengdu/CN
  • 10 Medical Oncology, The First Affiliated Hospital of Guangzhou Medical University, Guangdong Sheng/CN
  • 11 Tumor Center, The First Hospital of Jilin University, Changchun/CN
  • 12 Department Of Thoracic Oncology, West China Hospital of Sichuan University, Chengdu/CN
  • 13 Internal Medicine, Chulalongkorn University and the King Chulalongkorn Memorial Hospital, Bangkok/TH
  • 14 Thoracic Medicine, Chang Gung Memorial Hospital (Linko), Taoyuan/TW
  • 15 Clinical Development And Analytics, Novartis Pharmaceutical Corporation, East Hanover/US
  • 16 Global Drug Development, Novartis Pharma AG, Basel/CH
  • 17 Clinical Development, Novartis Pharmaceutical Corporation, East Hanover/US
  • 18 Guangdong Lung Cancer Institute, Guangdong Provincial People’s Hospital, Guangzhou/CN

Resources

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Abstract 3300

Background

In global phase III ASCEND-4 study (NCT01283516), ceritinib 750 mg/day (fasted), demonstrated statistically significant and clinically meaningful improvement in PFS by BIRC (median, 16.6 mos [95% CI: 12.6, 27.2] vs 8.1 mos [95% CI: 5.8, 11.1]; HR = 0.55; p < 0.001) compared to chemotherapy (pemetrexed 500 mg/m2 + cisplatin 75 mg/m2 or carboplatin AUC 5-6, followed by pemetrexed maintenance) in untreated pts with advanced ALK+ NSCLC. Here, we report the efficacy and safety of ceritinib in Asian pts from ASCEND-4 study.

Methods

Pts with stage IIIB/IV, ALK + (centrally tested IHC), nonsquamous NSCLC, ≥1 measurable lesion per RECIST v1.1, and WHO PS 0–2 were eligible. Efficacy and safety were evaluated in Asian pts who had not received prior systemic anticancer therapy except neo-/adjuvant therapy. Data cutoff: June 24, 2016.

Results

Among 376 pts randomized (1:1) in the study, 158 pts were Asian, with 76 in ceritinib arm and 82 in chemotherapy arm. Of these, 25 pts (32.9%) in ceritinib arm and 21 (25.6%) in chemotherapy arm had brain metastases at baseline. Median duration of treatment exposure: 64.5 wks (ceritinib, N = 76) and 35.0 wks (chemotherapy, N = 75). Median duration from randomization to data cutoff: 18.3 mos. Ceritinib demonstrated superior PFS by BIRC (median, 26.3 mos; 95% CI: 8.6, NE; HR = 0.66) compared to chemotherapy (Table). Most common (≥50%; all grades; all-causality) AEs in ceritinib arm: diarrhea (85.5%), ALT increased (73.7%), vomiting (73.7%), AST increased (69.7%), and nausea (69.7%). Incidence of grade 3/4 AEs was <6%, except ALT increased (38.2%), GGT increased (22.4%), AST increased (21.1%), fatigue (7.9%), amylase increased (6.6%), and hyperglycemia (6.6%). Only 7 pts (9.2%) discontinued ceritinib due to AEs.Table:

1473P

By BIRC (N*=158)
Ceritinib 750mg N = 76Chemotherapy N = 82
Overall response rate (ORR), % [95% CI]65.8 [54.0, 76.3]29.3 [19.7, 40.4]
Best overall response, n (%) Complete response (CR) Partial response (PR) Stable disease (SD) Progressive disease (PD) Non-CR/Non-PD Unknown 0 50 (65.8) 11 (14.5) 11 (14.5) 2 (2.6) 2 (2.6) 0 24 (29.3) 38 (46.3) 6 (7.3) 3 (3.7) 11 (13.4)
Disease control rate (DCR), % [95% CI]82.9 [72.5, 90.6]79.3 [68.9, 87.4]
M=50M=24
Median DOR, months [95% CI]NE [24.7, NE]16.4 [7.8, NE]
n/N (%)14/50 (28.0)8/24 (33.3)
% Event-free probability estimates [95% CI]
 9 months81.2 [67.0, 89.8]76.1 [48.0, 90.4]
 12 months79.0 [64.5, 88.1]50.8 [22.5, 73.5]
 15 months70.4 [54.0, 81.9]50.8 [22.5, 73.5]
Median PFS, months [95% CI]26.3 [8.6, NE]10.6 [6.7, 15.0]
n/N (%)32/76 (42.1)45/82 (54.9)
% Event-free probability estimates [95% CI]
 9 months61.0 [48.4, 71.5]54.7 [41.8, 65.8]
 12 months61.0 [48.4, 71.5]49.8 [37.1, 61.2]
 15 months55.9 [43.2, 66.9]39.0 [26.9, 51.0]
*

Total number of patients included in the full analysis set.

Total number of patients with confirmed complete response or partial response. n: Total number of events included in the analysis. N: Total number of patients included in the analysis.

Conclusions

In Asian pts with ALK+ NSCLC, ceritinib demonstrated durable and clinically meaningful efficacy and a safety profile consistent with overall ASCEND-4 study results.

Clinical trial identification

NCT01828099.

Editorial acknowledgement

Shilpa Garg, Novartis Healthcare Pvt Ltd.

Legal entity responsible for the study

Novartis Pharmaceuticals Corporation.

Funding

Novartis Pharmaceuticals Corporation.

Disclosure

D.S. Tan: Honoraria (self): Merck, Pfizer, Novartis, Boehringer Ingelheim, Roche, Takeda; Advisory / Consultancy: Novartis, Bayer, Boehringer Ingelheim, Celgene, AstraZeneca, Eli-lily, Loxo; Research grant / Funding (self): Novartis, AstraZeneca, GlaxoSmithKline, Bayer, Pfizer; Travel / Accommodation / Expenses: Merck, Pfizer, Novartis, Boehringer Ingelheim, Roche,Takeda. S. Geater: Advisory / Consultancy: Boehringer Ingelheim; Honoraria (institution): AstraZeneca, Boehringer Ingelheim; Research grant / Funding (institution): AstraZeneca, Roche, Novartis, Boehringer Ingelheim; Full / Part-time employment: Prince of Songkla Univerisity. C.J. Yu: Honoraria (self): Roche, AstraZeneca, Ono pharma, Boehringer Ingelheim; Advisory / Consultancy: Roche, AstraZeneca, Ono pharma, Boehringer Ingelheim. T.C. Hsia: Advisory / Consultancy: Norvatis, Lilly, AZ, Roche local speaker. M.C. Lin: Advisory / Consultancy: AZ, Novartis, BI, Roche. V. Sriuranpong: Advisory / Consultancy, Speaker Bureau / Expert testimony: AstraZeneca, Novartis, Roche, Pfizer, Eisai, Boehringer, Taiho, MSD, BMS, Amgen; Research grant / Funding (institution): AstraZeneca, Novartis, Roche, Pfizer, Boehringer, Eisai, Taiho, Lilly, MSD. P. Sen: Shareholder / Stockholder / Stock options, Full / Part-time employment: Novartis. F. Branle: Shareholder / Stockholder / Stock options, Full / Part-time employment: Novartis. M. Shi: Shareholder / Stockholder / Stock options: Novartis stock; Full / Part-time employment: Novartis. Y.L. Wu: Honoraria (self): AZ, Roche, Eli Lilly, Pfizer, MSD, BMS, BI; Advisory / Consultancy: AZ, Roche, BI; Research grant / Funding (institution): AZ, Roche. All other authors have declared no conflicts of interest.

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