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Boehringer Ingelheim presents strong lung cancer portfolio and long-awaited head-to-head data of afatinib compared to gefitinib at ESMO Asia 2015 Congress

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

Abstract available

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

Abstract available

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

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

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

Abstract available

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

Abstract available

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

Abstract available

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

Abstract available

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,
Qingyuan Zhang, Anthony Chan,
Sung-Bae Kim, Cheng-Hsu Wang,
Xiaohui He, Wei Guo, Jin Hyoung
Kang, Arunee Dechaphunkul, Ping
Li, Alaa Kandil, Ezra Cohen, Guo-qiang
Hu, Yuan Geng, Eva
Ehrnrooth, Ye Guo

 

 

Date: Sunday 20 December

Time: 13.30-14.15

Location: Exhibition and poster area

Abstract: 340TiP

Poster Display Session

Abstract available

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

Abstract available

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

Abstract available

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

Abstract available

*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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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.

For notes to editors please visit:

https://www.boehringer-ingelheim.com/news/news_releases/press_releases/2015/18_december_2015_oncology.html

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Corporate Communications
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Dr. Reinhard Malin
Phone: +49 6132 – 77 90815
Fax: +49 6132 – 77 6601
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