- 12 abstracts for four compounds accepted including: new results from head-to-head trials comparing 2nd-generation EGFR TKI, afatinib, with 1st-generation EGFR TKIs, gefitinib and erlotinib
- Updated data for 3rd-generation EGFR TKI, BI 1482694, showing strong anti-tumour activity and favourable safety profile in patients whose tumours have progressed on initial EGFR TKI treatment
- Further data for triple angiokinase inhibitor nintedanib and IGF-1/IGF-2 co-neutralising mAb, BI 836845
INGELHEIM, Germany I December 18, 2015 I Boehringer Ingelheim today announced that the latest data from its oncology portfolio will be presented at the ESMO Asia 2015 Congress in Singapore, 18-21 December 2015. New data for BI 1482694* (HM61713**) demonstrate a strong anti-tumour activity (confirmed objective response and disease control rates) with a favourable safety profile in patients with epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) whose tumours have acquired the most common mechanism of resistance, the T790M mutation, and have stopped responding to treatment with previous 1st- and/or 2nd-generation EGFR targeted therapies. BI 1482694 is a novel, 3rd-generation, EGFR mutant-specific tyrosine kinase inhibitor (TKI).
Dr Mehdi Shahidi, Medical Head, Solid Tumour Oncology, Boehringer Ingelheim commented, “We are looking forward to presenting the exciting new data from our oncology portfolio at ESMO Asia 2015 Congress. The results of the two head-to-head trials of afatinib versus 1st-generation TKIs, gefitinib and erlotinib, could provide guidance to the practicing oncologist on the choice of TKIs in EGFR-mutated and squamous cell lung cancer, respectively. We are also excited to present the latest results for BI 1482694, Boehringer Ingelheim’s newest compound, as we strive to extend the continuum of treatment with targeted therapies for patients with EGFR-mutated lung cancer and delay the burdensome side effects of chemotherapy for even longer.”
Data for Boehringer Ingelheim Oncology Compounds at ESMO Asia 2015 Congress
Title | Authors | Abstract Details | |||
BI 1482694* | |||||
Clinical activity and safety of the EGFR mutant-specific inhibitor, BI1482694, in patients (pts) with T790M-positive NSCLC |
Jong-Seok Lee, Keunchil Park, Ji-Youn Han, Ki Hyeong Lee, Joo-Hang Kim, Eun Kyung Cho, Jae Yong Cho, Young Joo Min, Jin-Soo Kim, Hoon-Gu Kim, Bong-Seog Kim, Jina Jung, Dong-Wan Kim |
Date: Saturday 19 December Time: 16.30–17.30 Location: Hall 332 Abstract: 425PD Poster Discussion Session |
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Phase II study of BI1482694 in patients (pts) with T790M-positive non-small cell lung cancer (NSCLC) after treatment with an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) |
Pasi A. Jänne, Jeewoong Son, Isabelle Voccia, Martina Uttenreuther-Fischer, Keunchil Park |
Date: Sunday 20 December Time: 13.30–14.15 Location: Exhibition and Poster Area Abstract: 476TiP Poster Display Session |
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Afatinib*** | |||||
Second-line afatinib vs methotrexate (MTX) in patients (pts) with recurrent and/or metastatic head and neck squamous cell carcinoma (R/M HNSCC): subgroup/biomarker analysis of LUX-Head and Neck 1 (LUX-H&N1) |
Makoto Tahara, Ezra E. W. Cohen, Robert I. Haddad, Jérôme Fayette, Lisa F. Licitra, Paul M. Clement, Jan B. Vermorken, Thomas Gauler, Didier Cupissol, Juan José Grau, Joël Guigay, Joseph M. del Campo, Kenji Okami, Shunji Takahashi, Barbara Burtness, Xiuyu Julie Cong, Neil Gibson, Flavio Solca, Eva Ehrnrooth, Jean-Pascal H. Machiels |
Date: Friday 18 December Time: 14.30–14.40 Location: Hall 332 Abstract: 3140 Proffered Paper Session Abstract available at time of presentation |
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Afatinib (A) vs gefitinib (G) as first-line treatment for patients (pts) with advanced non-small cell lung cancer (NSCLC) harboring activating EGFR mutations: results of the global, randomized, open-label, Phase IIb trial LUX-Lung 7 (LL7) |
Keunchil Park, Eng-Huat Tan, Li Zhang, Vera Hirsh, Kenneth O’Byrne, Michael Boyer, James Chih-Hsin Yang, Tony Mok, Miyoung Kim, Dan Massey, Victoria Zazulina, Luis Paz-Ares |
Date: Sunday 20 December Time: 16.30–16.45 Location: Hall 406 Abstract: LBA2 Proffered Paper Session Abstract available at time of presentation |
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Phase III trial of afatinib vs erlotinib in patients (pts) with squamous cell carcinoma (SCC) of the lung (LUX-Lung 8): EGFR molecular aberrations and survival outcomes |
Keunchil Park, Wei Li, Caicun Zhou, Enriqueta Felip, Manuel Cobo, Glenwood D. Goss, Jean-Charles Soria, Konstantinos Syrigos, Nicole Krämer, Vikram K. Chand, Flavio Solca and Shun Lu, for the LUX-Lung 8 Investigators |
Date: Sunday 20 December Time: 13.30-14.15 Location: Exhibition and poster area Abstract: 443P Poster Display Session |
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Afatinib (A) versus chemotherapy (CT) for EGFR mutation-positive NSCLC patients (pts) aged ≥65 years: subgroup analyses of LUX-Lung 3 (LL3) and LUX-Lung 6 (LL6) |
Yi-Long Wu, Lecia V Sequist, Sarayut L Geater, Sergey Orlov, Ki Hyeong Lee, Chun-Ming Tsai, Terufumi Kato, Katsuyuki Kiura, Carlos H Barrios, Martin Schuler, Vera Hirsh, Nobuyuki Yamamoto, Kenneth O’Byrne, Tony Mok, Dan Massey, Angela Märten, James Chih-Hsin Yang |
Date: Sunday 20 December Time: 13.30-14.15 Location: Exhibition and poster area Abstract: 446P Poster Display Session |
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Overall survival (OS) with afatinib (A) vs chemotherapy (CT) in patients (pts) with NSCLC harboring EGFR mutations (mut): subgroup analyses by race in LUX-Lung 3 (LL3) and LUX-Lung 6 (LL6) |
Yi-Long Wu, Lecia V Sequist , Martin Schuler, Nobuyuki Yamamoto, Caicun Zhou, Cheng-Ping Hu, Kenneth O’Byrne, Vera Hirsh, Tony Mok, Victoria Zazulina, James Chih-Hsin Yang |
Date: Sunday 20 December Time: 13.30-14.15 Location: Exhibition and poster area Abstract: 445P Poster Display Session |
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Phase IV study of afatinib as second-line therapy for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring common epidermal growth factor receptor (EGFR) mutations (Del19 and/or L858R) |
Sumitra Thongprasert, Aurelia Alexandru, Michael Schenker, Amr Abdelaziz, Dana Clement, Cosmin Boldeanu, Dragana Jovanovic, Jasmin Reyes-Igama, Marina Petrović, Sarayut Geater, Davorin Radosavljević, Branislav Perin, Maciej Krzakowski, Piotr Serwatowski, Joseph Parra, Virote Sriuranpong, Hilary Jones, Agnieszka Cseh, Rabab Gaafar |
Date: Sunday 20 December Time: 13.30-14.15 Location: Exhibition and poster area Abstract: 477TiP Poster Display Session |
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Phase III study of afatinib vs methotrexate (MTX) for second-line recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) patients after platinum-based chemotherapy (CT) in Asia/Middle East/North Africa: LUX-Head & Neck 3 (LUX-H&N3) |
Ping Zhang Tang, Myung-Ju Ahn, |
Date: Sunday 20 December Time: 13.30-14.15 Location: Exhibition and poster area Abstract: 340TiP Poster Display Session |
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Phase III study of afatinib vs placebo as adjuvant therapy after chemo-radiotherapy (CRT) in primary unresected patients with locoregionally advanced (LA) head and neck squamous cell carcinoma (HNSCC) in Asia: LUX-Head & Neck 4 (LUX-H&N4) |
Chao Su Hu, Anthony Chan, Li Gao, Myung-Ju Ahn, Ezra Cohen, Mei Kim Ang, Ying Cheng, Qiaoying Hu, Sung-Bae Kim, Ping Li, Yan Sun, Bei Fan, Gang Cheng, Eva Ehrnrooth, Cheng-Hsu Wang |
Date: Sunday 20 December Time: 13.30-14.15 Location: Exhibition and poster area Abstract: 339TiP Poster Display Session |
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Nintedanib**** | |||||
Efficacy of nintedanib/docetaxel in East Asian patients with lung adenocarcinoma (ADE): Analysis from the LUME-Lung 1 study |
Yi-Long Wu, Ying Cheng, Bong-Seog Kim, Shun Lu, Birgit Gaschler-Markefski, Rolf Kaiser, Martin Reck |
Date: Sunday 20 December Time: 13.50-14.15 Location: Exhibition and poster area Abstract: 438P Poster Display Session |
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BI 836845***** | |||||
Phase Ib trial of afatinib and BI 836845 in advanced non-small cell lung cancer (NSCLC) |
Daniel Shao Weng Tan, Chia-Chi Lin, Dennis Chin-Lun Huang, Helen Jung, Thomas Bogenrieder, Keunchil Park |
Date: Sunday 20 December Time: 13.30-14.15 Location: Exhibition and poster area Abstract: 479TiP Poster Display Session |
*BI 1482694 is an investigational, novel, oral, 3rd-generation, EGFR mutant-specific tyrosine kinase inhibitor (TKI) developed to specifically target tumours with EGFR mutations including the resistance mutation T790M.
**Boehringer Ingelheim has an exclusive license and collaboration agreement with Hanmi Pharmaceutical Co. Ltd for the development and global commercialisation rights (except South Korea, China and Hong Kong) of BI 1482694 (HM61713).
***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 836845, is an investigational, IGF ligand-neutralizing antibody that binds to both IGF-1 and IGF-2 and neutralises growth-promoting signaling.
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SOURCE: Boehringer Ingelheim