INGELHEIM, Germany - Thursday, May 14th 2015 [ME NewsWire]

• LUX-Lung 8 Phase III study evaluating the efficacy and safety of afatinib* vs. erlotinib for patients with advanced squamous cell carcinoma of the lung met secondary endpoint of overall survival

• 9 abstracts accepted including latest data for afatinib* and nintedanib** in lung cancer and beyond

(BUSINESS WIRE)-- Boehringer Ingelheim today announced that the latest data from its oncology portfolio will be presented at the Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, USA, 29 May – 2 June 2015. A total of 9 abstracts, including new data for afatinib* and nintedanib,** will emphasise the growing presence of Boehringer Ingelheim in lung and other cancer types.

The LUX-Lung 8 Phase III trial directly compared the efficacy and safety of two EGFR-directed treatments, afatinib* and erlotinib, in patients with advanced squamous cell carcinoma (SCC) of the lung, progressing after treatment with first-line chemotherapy. The study met its primary endpoint of progression-free survival, as well as its key secondary endpoint of overall survival. The overall survival data will be unveiled in an oral presentation. The outcome of the trial is highly anticipated due to the current poor prognosis and high level of unmet need for patients with this specific type of lung cancer.

Data for Boehringer Ingelheim (Investigational) Oncology Compounds at ASCO 2015

Title
          

Authors
          

Abstract Details
    

Afatinib*
    

Afatinib (A) vs erlotinib (E) as second-line treatment of patients (pts) with advanced squamous cell carcinoma (SCC) of the lung following first-line platinum-based chemotherapy: overall survival analysis from the LUX-Lung 8 Phase III global trial
          

J.C. Soria, E. Felip, M. Cobo, S. Lu, K.N. Syrigos, K.H. Lee, E. Göker, V. Georgoulias, K.W. Li, D. Isla, S.Z. Guclu, A. Morabito, YJ Min, A. Ardizzoni, S. Gadgeel, B Wang, V.K. Chand, G.D. Goss for the LUX-Lung 8 Investigators
          

Sunday, 31 May,

8:00 am – 11:00 am

Oral Abstract Session, Lung Cancer

Abstract #8002
    

Biomarker analysis in recurrent and/or metastatic head and neck squamous cell carcinoma (R/M HNSCC) patients (pts) treated with afatinib vs methotrexate (MTX): LUX-Head & Neck 1 (LUX-H&N1)
          

E.E.W. Cohen, L.F. Licitra, J. Fayette, T. Gauler, P.l.M. Clement, J.J. Grau, J.M. del Campo, A. Mailliez, R.I. Haddad, J.B. Vermorken, M. Tahara, J. Guigay, L.l. Geoffrois, M.oC. Merlan, N.F. Dupuis, X.J. Cong, N. Gibson, F. Solca, E. Ehrnrooth, J-P.H. Machiels
          

Saturday, 30 May,

1:15 pm – 4:45 pm

Poster Session, Head and Neck Cancer

Abstract #6023
    

Afatinib (A) vs erlotinib (E) as second-line treatment of patients (pts) with advanced squamous cell carcinoma (SCC) of the lung following first-line platinum-based chemotherapy: patient-reported outcome (PRO) data from the LUX-Lung 8 Phase III global trial
          

S. Gadgeel, M. Cobo, E. Felip, J.C. Soria, K.H. Lee, S. Lu, V. Georgoulias, A. Fulop,E. Göker, K.N. Syrigos, A. Morabito, H.S. Coskun, S.Z. Guclu, W. Li, S. Popat, A. Ardizzoni, J Lungershausen, B. Wang, V.K. Chand, G.D. Goss for the LUX-Lung 8 Investigators
          

Monday, 1 June,

8:00 am – 11:30 am

Poster session, Lung Cancer

Abstract #8100
    

Phase Ib study of afatinib plus standard-dose cetuximab in patients (pts) with advanced solid tumors
          

A. Gazzah, V. Boni, J.C. Soria, E. Holgado, C. Even, M. Ould-Kaci, S. Nazabadioko, W. Xue, E. Calvo
          

Saturday, 30 May,

8:00 am – 11:30 am

Poster Session, Developmental Therapeutics and Translational Research

Abstract #2536
    

Influence of dose adjustment on afatinib safety and efficacy in patients (pts) with advanced EGFR mutation-positive (EGFRm+) non-small cell lung cancer (NSCLC)
          

J.C-H. Yang, M-J. Ahn, N.J. Dickgreber, B. Halmos, V. Hirsh, M.J. Hochmair, B.P. Levy, F. de Marinis, T. Mok, K. O’Byrne, I. Okamoto, M. Schuler, M. Sebastian, R. Shah, E-H. Tan, N. Yamamoto, A. Märten, D. Massey, S. Wind, D.P. Carbone
          

Monday, 1 June,

8:00 am – 11:30 am

Poster Session, Lung Cancer

Abstract #8073
    

Mechanisms of acquired afatinib resistance in HER2-positive breast cancer cells
          

A. Canonici
          

Saturday, 30 May,

8:00 am – 11:30 am

Poster Session, Breast Cancer

Abstract #620
    

Nintedanib**
    

LUME-Colon 1: a double-blind, randomized Phase III study of nintedanib plus best supportive care (BSC) versus placebo plus BSC in patients with colorectal cancer (CRC) refractory to standard therapies
          

H.J. Lenz, J. Tabernero, T. Yoshino, Z. Oum’Hamed, S. Vlassak, M. Sassi, E. Van Cutsem
          

Monday, 1 June,

8:00 am – 11:30 am

Poster Session, Gastrointestinal (Colorectal) Cancer

Abstract #TPS3625
    

Efficacy and safety of nintedanib (N) versus sorafenib (S) in Caucasian and Asian patients with advanced hepatocellular carcinoma (HCC): pooled analysis of two randomized Phase II trials
          

T. Meyer, D. Palmer, Y. Chao, C. Choi, A. Deptala, L. Fartoux, Y-H. Feng, J. Graham, J. Hocke, T-Y. Kim, D-Y Lin, Y.T. Ma, M. Peck-Radosavljevic, P. Ross, B-Y Ryoo, A. Wenz, C-J. Yen, A-B. Loembé, A-L. Cheng
          

Monday, 1 June,

8:00 am – 11:30 am

Poster Session, Gastrointestinal (Noncolorectal) Cancer

Abstract #4074
    

BI 853520 (focal adhesion kinase (FAK) inhibitor***)
    

A phase I study of BI 853520, an inhibitor of focal adhesion kinase (FAK), in patients with advanced or metastatic solid tumors
          

A. Zer, R.B. Verheijen, F. De Vos, S. Hotte, F. Eskens, L.C. Pronk, L.L. Siu, D. Schnell, N. Steeghs, M. Langenberg, H. Hirte, M. de Jonge
          

Saturday, 30 May,

8:00 am – 11:30 am

Poster Session, Developmental Therapeutics and Translational Research

Abstract #2541
    

*Afatinib is approved in a number of markets, including the EU, Japan, Taiwan and Canada under the brand name GIOTRIF® and in the US under the brand name GILOTRIF® for use in patients with distinct types of EGFR mutation-positive NSCLC. Registration conditions differ internationally, please refer to locally approved prescribing information. Afatinib is under regulatory review by health authorities in other countries worldwide. Afatinib is not approved in other indications.

**Nintedanib is approved in the EU under the brand name VARGATEF® for use in combination with docetaxel in adult patients with locally advanced, metastatic or locally recurrent NSCLC of adenocarcinoma tumour histology after first-line chemotherapy. Nintedanib is under regulatory review by health authorities in other countries outside the EU. Nintedanib is not approved in other oncology indications.

***BI 853520 is an investigational compound and is not yet approved. Its safety and efficacy have not yet been fully established.

For notes to editors please visit https://www.boehringer-ingelheim.com/news/news_releases/press_releases/2015/14_may_2015_oncology.html

For more information please visit www.boehringer-ingelheim.com

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This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.

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