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Poster display session

4641 - Long-term response to second-line afatinib in patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC): analysis of the LUX-Head & Neck 1 (LHN1) trial


10 Sep 2017


Poster display session


Cytotoxic Therapy;  Cancers in Adolescents and Young Adults (AYA);  Head and Neck Cancers


Jean-Pascal Machiels


Annals of Oncology (2017) 28 (suppl_5): v372-v394. 10.1093/annonc/mdx374


J. Machiels1, G. de Castro Jr2, L. de Souza Viana3, R. Galiulin4, M. Tahara5, U.R. Nicolau6, C. Le Tourneau7, K. Okami8, V. Vladimirov9, A. Izmailov10, K. Hoermann11, L. Licitra12, R. Haddad13, E.E. Cohen14, N. Dupuis15, J. Love16, E. Zografos17, E. Ehrnrooth18, J. Fayette19

Author affiliations

  • 1 Institut Roi Albert Ii, Service D’oncologie Médicale, Cliniques Universitaires Saint-luc And Institut De Recherche Clinique Et Expérimentale (pole Miro), Université Catholique de Louvain, 00 - Brussels/BE
  • 2 Department Of Clinical Oncology, Instituto do Câncer do Estado, São Paulo/BR
  • 3 Department Of Medical Oncology, Hospital de Câncer de Barretos, São Paulo/BR
  • 4 Chemotherapy Department, Omsk Regional Oncology Center, Omsk/RU
  • 5 Division Of Head And Neck Medical Oncology, National Cancer Center Hospital East, Kashiwa/JP
  • 6 Departamento De Oncologia, Hospital A.C. Camargo, São Paulo/BR
  • 7 Department Of Medical Oncology, Institut Curie, Paris/FR
  • 8 Department Of Otolaryngology, Tokai University, Isehara/JP
  • 9 Policlinic, Pyatigorsk Oncological Dispensary, Pyatigorsk/RU
  • 10 Department Of Oncology, Bashkirin State Medical University, Ufa/RU
  • 11 Department Of Otolaryngology, Head And Neck Surgery, University Hospital Mannheim, Mannheim/DE
  • 12 Fondazione Irccs Istituto Nazionale Tumori, Milan, It, and University of Milan, Milan/IT
  • 13 Department Of Medical Oncology, Dana-farber Cancer Institute, Harvard Medical School and Department of Medicine, Brigham and Women’s Hospital, Boston/US
  • 14 San Diego Moores Cancer Center, University of California, La Jolla/US
  • 15 Development, Biodesix Inc., Boulder/US
  • 16 Oncology Statistics, Boehringer Ingelheim Corporation, Ridgefield/US
  • 17 N/a, Boehringer Ingelheim, Bracknell/GB
  • 18 Ta Oncology, Boehringer Ingelheim, Danmark A/S, Copenhagen/DK
  • 19 Léon Bérard Center And Hospices Civils De Lyon, University of Lyon, 69008 - Lyon/FR


Abstract 4641


In the Phase III LHN1 trial, second-line afatinib (A) significantly improved PFS (primary endpoint) vs methotrexate (MTX) in pts with R/M HNSCC. Tumour biomarker analyses have shown that survival benefit with A vs MTX was more pronounced in pts with p16/ErbB3-negative, EGFR-amplified, PTEN-positive disease. We present post-hoc analyses of A long-term responders (LTRs).


Pts with incurable R/M HNSCC who had received first-line platinum-based therapy were randomised to A (40mg/day) or MTX (40mg/m2/week) and treated until progression/intolerable AE. LTRs were defined as pts treated with A ≥ 12 mos. Tumour biomarkers were assessed by IHC (p16, ErbB3, PTEN, cMET) and FISH (EGFR amplification); pre-treatment (tx) serum samples were analysed with the VeriStrat® (VS) test and classified as VS-Good/Poor.


11/322 (3%) pts treated with A were LTRs with a median (range) tx-duration of 16 (12–39) mos. All pts had stopped tx at analysis. Baseline characteristics in LTRs were similar to the overall dataset, except (LTRs/overall): oral cavity primary tumour site (45%/29%); M1 disease (45%/66%); previous therapy with EGFR-antibodies (18%/59%). Median OS was 18.1 mos; median PFS (central independent review) was 14.9 mos. ORR was 45% (CR: 18%; n = 2). The frequency of pts who received ≥1 subsequent therapy was similar to the overall dataset (LTRs, 45%; overall, 51%). In LTRs with available biomarker data, 3/3 (100%) pts were p16-negative, 4/4 (100%) pts were ErbB3-negative, 2/4 (50%) pts were PTEN-positive, 3/3 (100%) pts were cMET-positive, 2/3 (67%) pts had EGFR-amplification, and 5/5 (100%) pts were VS-Good. Tolerability-guided dose reductions were more frequent among LTRs (55% vs 32% overall).


In the LHN1 study, some platinum-pre-treated pts with R/M HNSCC derived a long-term survival benefit from A; median OS was ∼1.5 yrs and >11 mos longer than in the overall dataset. Limited biomarker data available in these LTRs suggests that p16/ErbB3-negativity and EGFR-amplification might be potential predictive biomarkers for long-term benefit from A; however, results were not conclusive due to small sample size.

Clinical trial identification


Legal entity responsible for the study

Boehringer Ingelheim


Boehringer Ingelheim


J-P. Machiels: Reports taking part in advisory boards for Debio, Innate, Nanobiotix, MSD, AstraZeneca, and grants from Janssen, Bayer, and Novartis outside the submitted work. K. Okami: Honoraria: Merck Serono Co., Ltd C. Le Tourneau: Advisory board: MSD, Amgen, BMS. Honoraria: MSD, BMS, Merck Serono, Novartis. E. Zografos: Employment Boehringer Ingelheim L. de Souza Viana: Research funding from Boehringer Ingelheim. L. Licitra: Participated in advisory boards for Eisai, Bristol-Myers Squibb, GlaxoSmithKline, Lilly, Merck Serono, Amgen, Boehringer Ingelheim, Debiopharm, VentiRX, SOBI, Novartis, AstraZeneca and Bayer. E. Cohen: Participated in a consulting or advisory role for AstraZeneca, Bayer, Bristol-Myers Squibb, Eisai, Merck, and Novartis, and has participated in speakers’ bureaus for Bayer and Eisai. N. Dupuis: Owns stock in Biodesix. J. Love, E. Ehrnrooth: Employee of Boehringer Ingelheim. J. Fayette: Received honoraria from Bristol-Myers Squibb and AstraZeneca. R. Galiulin, M. Tahara, K. Hoermann: COI to follow All other authors have declared no conflicts of interest.

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