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Proffered paper session 1

865 - 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 (410O_PR)

Date

18 Nov 2017

Session

Proffered paper session 1

Presenters

Tony S.K. Mok

Citation

Annals of Oncology (2017) 28 (suppl_10): x186-x195. 10.1093/annonc/mdx729

Authors

T.S.K. Mok1, S. Peters2, D..R. Camidge3, S.I. Ou4, J.S. Ahn5, E.H. Tan6, Z. Li7, J. Lee8, B.C. Cho9, S.L. Geater10, V. Sriuranpong11, J. Ho12, O.S. Chan13, A. Zeaiter14, B. Balas14, E. Nueesch14, E. Mitry14, P.N. Morcos15, D. Kim16

Author affiliations

  • 1 Department Of Clinical Oncology, The Chinese University of Hong Kong, 00000 - Hong Kong/HK
  • 2 Department Of Oncology, Lausanne University Hospital, 1011 - Lausanne/CH
  • 3 Division Of Medical Oncology, University of Colorado, Denver/US
  • 4 Medicine, Hematology Oncology, Chao Family Comprehensive Cancer Center, University of California, Irvine School of Medicine, Orange/US
  • 5 Medicine, Sungkyunkwan University School of Medicine, Seoul/KR
  • 6 Medical Oncology, National Cancer Centre Singapore, Singapore/SG
  • 7 Medical Oncology, Sun Yat-Sen University Cancer Center, Guangzhou/CN
  • 8 Medical Oncology, Seoul National University Bundang Hospital, Seongnam-si/KR
  • 9 Medical Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul/KR
  • 10 Internal Medicine, Prince of Songkla University, Songkhla/TH
  • 11 Medical Oncology Unit, Department Of Medicine, Chulalongkorn University, 10330 - Bangkok/TH
  • 12 Respiratory Medicine, The University of Hong Kong, Hong Kong/HK
  • 13 Department Of Clinical Oncology, Pamela Youde Nethersole Eastern Hospital, Chai Wan/HK
  • 14 Medical Oncology, F. Hoffmann-La Roche Ltd., Basel/CH
  • 15 Clinical Pharmacology, Roche Innovation Center, New York/US
  • 16 Department Of Internal Medicine, Seoul National University Hospital, Seoul/KR
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Abstract 865

Background

We present efficacy and safety data of Asian vs non-Asian patients (pts) in the global phase III ALEX study of ALC (600 mg BID) vs CRZ (250 mg BID) in treatment-naïve advanced ALK+ NSCLC.

Methods

Pts aged ≥18 years were randomised 1:1 to receive ALC or CRZ until progression, toxicity, withdrawal or death. Race was a randomisation stratification factor. The primary endpoint was investigator (INV)-assessed progression-free survival (PFS). Secondary endpoints were: Independent Review Committee (IRC)-assessed PFS, time to central nervous system (CNS) progression, objective response rate (ORR) by INV, overall survival (OS) and safety.

Results

In total, 303 pts were randomised (ALC N = 152 [N = 69 Asian, N = 83 non-Asian]; CRZ N = 151 [N = 69 Asian, N = 82 non-Asian]). Baseline characteristics were consistent between Asian and non-Asian subgroups, except median weight. Efficacy and safety data were similar between subgroups (table). PFS by INV was longer with ALC in Asian (HR 0.46) and non-Asian (HR 0.49) pts. Median OS has not yet been reached in either subgroup but data are immature: Asian HR 0.68, non-Asian HR 0.82. Rate of treatment discontinuation due to adverse events (AE): Asian 13.0% ALC, 11.6% CRZ; non-Asian 9.6% ALC, 13.4% CRZ. AE profiles of Asian and non-Asian subgroups were consistent with the ITT population. Diarrhoea was more common with CRZ in both subgroups vs ALC (Asian 15.0% ALC, 39.1% CRZ; non-Asian 10.0% ALC, 50.0% CRZ). Nausea was more common with CRZ in both subgroups vs ALC (Asian 10.1% ALC, 42.0% CRZ; non-Asian 17.0% ALC, 52.4% CRZ) and was more common in non-Asian vs Asian pts. Pharmacokinetics data of the subgroups will be presented.

Conclusions

Efficacy and safety data were similar between Asian and non-Asian pts for ALC or CRZ. The results confirm ALC 600 mg BID dosage is more effective than CRZ in Asian and non-Asian pts, and has an acceptable safety profile in Asian pts.

Clinical trial identification

NCT02075840

Legal entity responsible for the study

F. Hoffmann-La Roche

Funding

F. Hoffmann-La Roche Ltd.

Disclosure

T.S.K. Mok: Consultant (Participated in Advisory Boards for the last two years): AstraZeneca, BI, Pfizer, Novartis, SFJ, Roche, MSD, Clovis Oncology, BMS, Eisai and Taiho. S. Peters: Education grants, provided consultation, attended advisory boards and/or provided lectures for the following organizations: Amgen, AstraZeneca, Boehringer-Ingelheim, Bristol-Myers Squibb, Clovis, Eli Lilly, F. Hoffmann-La Roche, Janssen, Merck Sharp and Dohme and Merck Serono, Pfizer, Regeneron and Takeda. D.R. Camidge: Roche Genetech, Genoptix, G1 Therapeutics, Orion, Clovis, Ariad, Novartis, Celgene, Array, Abbvie, Eli Lilly. S-H.I. Ou: Corporate-sponsored research to institutions: Pfizer, Roche, Astra Zeneca, ARIAD, Ignyta and other substantive relationships including: Pfizer, Roche, Astra Zeneca, ARIAD, Ignyta and Foundation Medicine. J.S. Ahn: Personal fees from BMS, Eisai, Janssen, Roche, Menarini and Boehringer Ingelheim, B.C. Cho: Research funding: Novartis, Bayer, AstraZeneca, MOGAM Institute, Dong-A ST; Consulting role: Novartis, AstraZeneca, Boehringer-Ingelheim, Roche, BMS, Yuhan, Pfizer, Eli Lilly. S.L. Geater: Funding to institute for clinical research: Astra Zaneca, Boehringer Ingelheim, Novartis, Samsung, Roche, J. Ho: Speaker’s honorarium and research funding from Roche. A. Zeaiter: Employment at F. Hoffmann-La Roche. B. Balas: Employee and stockholder at F. Hoffmann-La Roche Ltd. E. Nueesch, E. Mitry: Employee at F. Hoffmann-La Roche, P.N. Morcos: Employment and stock ownership at F. Hoffmann-La Roche. All other authors have declared no conflicts of interest.

Table: 410O_PR

Efficacy and safety data by subgroups

Asian (N = 138)Non-Asian (N = 165)
ALC (N = 69)CRZ (N = 69)ALC (N = 83)CRZ (N = 82)
Median PFS (95% CI), INVNE (14.7–NE)10.9 (8.6–16.4)NE (14.0–NE)11.1 (8.8–14.6)
HR (95% CI) P-value0.46 (0.28–0.75) 0.00130.49 (0.32–0.75) 0.0009
Median PFS (95% CI), IRC25.7 (14.7–NE)10.8 (7.5–16.4)NE (14.6–NE)9.8 (7.3–16.7)
HR (95% CI) P-value0.49 (0.30–0.79) 0.00260.56 (0.36–0.87) 0.0091
CNS progression 12-month cumulative incidence, % (95% CI)9.0 (3.6–17.4)44.9 (32.3–56.7)9.6 (4.5–17.2)38.4 (27.6–49.1)
Cause-specific HR (95% CI)0.20 (0.10–0.42)0.13 (0.06–0.29)
ORR, % (95% CI), INV81.2 (69.94–89.57)76.8 (65.09–86.13)84.3 (74.71–91.39)74.4 (63.56–83.40)
Most frequent AE, n (%) Nausea Diarrhoea Constipation Vomiting Fatigue Increased ALT Increased AST Dyspnoea Dizziness7 (10.1) 10 (15.0) 28 (41.0) 7 (10.1) 14 (20.3) 15 (22.0) 14 (20.3) 2 (3.0) 8 (11.6)29 (42.0) 27 (39.1) 29 (42.0) 33 (48.0) 5 (7.2) 26 (38.0) 20 (29.0) 2 (3.0) 13 (19.0)14 (17.0) 8 (10.0) 24 (29.0) 4 (5.0) 15 (18.1) 8 (10.0) 7 (8.4) 7 (8.4) 4 (5.0)43 (52.4) 41 (50.0) 20 (24.4) 25 (31.0) 20 (24.4) 19 (23.2) 17 (21.0) 5 (6.1) 8 (10.0)

INV, investigator; IRC, Independent Review Committee; HR, hazard ratio; CNS, central nervous system; CI, confidence interval; AE, adverse event; ALT, alanine aminotransferase; AST, aspartate aminotransferase

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