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Presidential Symposium 3

4092 - Primary results of ALESIA: A randomised, phase III, open-label study of alectinib vs crizotinib in Asian patients with treatment-naïve ALK+ advanced NSCLC


22 Oct 2018


Presidential Symposium 3


Caicun Zhou


C. Zhou1, Y. Lu2, S. Kim3, T. Reungwetwattana4, J. Zhou5, Y. Zhang6, J. He7, J. Yang8, Y. Cheng9, S.H. Lee10, L. Bu11, T. Xu11, L. Yang11, C. Wang11, P.N. Morcos12, E. Mitry13, T. Liu14, L. Zhang15

Author affiliations

  • 1 Medical Oncology, Shanghai Pulmonary Hospital, Tongji University, 200433 - Shanghai/CN
  • 2 Thoracic Oncology, West China Hospital, Sichuan University, 610041 - Chengdu/CN
  • 3 Department Of Oncology, Asan Medical Center, 05505 - Seoul/KR
  • 4 Faculty Of Medicine, Ramathibodi Hospital, 10400 - Bangkok/TH
  • 5 Department Of Respiratory Disease, Thoracic Disease Center, The First Affiliated Hospital, College of Medicine, Zhejiang University, 310003 - Hangzhou/CN
  • 6 Medical Oncology, Zhejiang Cancer Hospital, 310022 - Hangzhou/CN
  • 7 Medical Oncology, First Affiliated Hospital of Guangzhou Medical University, Guangzhou/CN
  • 8 Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, 510080 - Guangzhou/CN
  • 9 Medical Oncology, Jilin Province Tumor Hospital, Changchun/CN
  • 10 Division Of Hematology-oncology, Department Of Medicine, Samsung Medical Center, 06351 - Seoul/KR
  • 11 Biometrics, Roche Product Development in Asia Pacific, 201203 - Shanghai/CN
  • 12 Clinical Pharmacology, Roche Innovation Center, 10016 - New York/US
  • 13 Product Development Oncology, F. Hoffmann-La Roche Ltd, 4070 - Basel/CH
  • 14 Product Development Oncology, F. Hoffmann-La Roche Ltd, Basel/CH
  • 15 Medical Oncology, Sun Yat-Sen University Cancer Center, 510060 - Guangzhou/CN


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Abstract 4092


Alectinib (ALC), a highly selective CNS-active ALK inhibitor, showed superior efficacy vs crizotinib (CRZ) in treatment-naïve ALK+ NSCLC in the global phase III ALEX study (PFS HR 0.47, 95% CI 0.34–0.65, p<0.001). At an updated data cutoff, the PFS HR was 0.43, 95% CI 0.32–0.58, median PFS 34.8 months ALC vs 10.9 months CRZ. We report primary results from the phase III ALESIA study of first-line ALC vs CRZ in Asian patients with advanced ALK+ NSCLC using the global ALC dose (NCT02838420).


Patients had ALK+ stage IIIB/IV NSCLC (by central IHC testing) and ECOG PS 0–2. Asymptomatic CNS metastases were allowed. Patients were randomised 2:1 to receive ALC 600mg BID (n=125) or CRZ 250mg BID (n=62). Regular tumour/CNS imaging was performed. Primary endpoint: PFS by INV (RECIST v1.1). Primary objective: consistency with the PFS benefit seen in ALEX. Secondary endpoints: PFS by IRC, time to CNS progression, ORR, DOR, OS, CNS ORR, QoL and safety.


Median duration of follow-up was 16.2 months ALC vs 15.0 months CRZ. At the primary data cutoff (May 31, 2018), ALC significantly reduced the risk of progression/death (INV PFS) vs CRZ: HR 0.22, 95% CI 0.13–0.38, p<0.0001; median PFS not estimable (NE) ALC vs 11.1 months CRZ. Secondary endpoints supported the primary endpoint: IRC PFS, HR 0.37 (95% CI 0.22–0.61; p<0.0001); median PFS NE ALC vs 10.7 months CRZ; time to CNS progression (IRC) cause-specific HR 0.14 (95% CI 0.06–0.30; p<0.0001); ORR (INV), 91.2% ALC vs 77.4% CRZ, p=0.0095; DOR (INV), HR 0.22 (95% CI 0.12–0.40), p<0.0001; median DOR NE ALC vs 9.3 months CRZ; OS data immature: HR 0.28 (95% CI 0.12–0.68), p=0.0027, event rate ALC 6.4% vs CRZ 21.0%; median OS NE both arms; CNS ORR (IRC) in patients with measurable/non-measurable CNS baseline lesions, 72.7% ALC vs 21.7% CRZ (50.0% vs 13.0% complete response). Despite longer treatment duration (14.7 ALC vs 12.6 months CRZ), fewer ALC patients had grade 3–5 AEs (29% vs 48% CRZ), serious AEs (15% vs 26%) or AEs leading to treatment discontinuation (7% vs 10%).


ALESIA study results are consistent with the global ALEX study and confirm the clinical benefit of ALC in Asian patients with advanced ALK+ NSCLC.

Clinical trial identification


Editorial Acknowledgement

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