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ASCO 2013: Boehringer Ingelheim to Present Data Across Multiple Cancers, Including Different Treatment Settings for Advanced NSCLC
Date:5/15/2013

RIDGEFIELD, Conn., May 15, 2013 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) today announced the upcoming presentation of data from 14 abstracts involving three of the company's investigational oncology compounds – afatinib*, nintedanib* and volasertib*. Results – to be presented at the 49th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, May 31-June 4, 2013 – are from Boehringer Ingelheim's robust oncology pipeline and demonstrate the company's commitment to the oncology community and patients through the research and development of new anti-cancer compounds. 

Data include results from three Phase III trials of nintedanib and afatinib across different populations of patients with advanced non-small cell lung cancer (NSCLC):

  • The LUME-Lung 1 trial (abstract #LBA8011): evaluating nintedanib in combination with a standard second-line chemotherapy (docetaxel) in patients with advanced NSCLC following treatment with first-line chemotherapy.  This presentation was accepted as a late-breaker.
  • The LUME-Lung 2 trial (abstract #8034): evaluating nintedanib in combination with a standard chemotherapy (pemetrexed) in patients with advanced NSCLC after relapse or failure of first-line chemotherapy.
  • The LUX-Lung 6 trial (abstracts #8016 & 8061): evaluating afatinib compared to a standard chemotherapy (gemcitabine and cisplatin) as first-line treatment in Asian patients with advanced NSCLC who have an epidermal growth factor receptor (EGFR) mutation.
  • "There are many scientific questions that remain unanswered in the care of patients with cancer, particularly with complex diseases such as lung cancer where there are many different subtypes," said Berthold Greifenberg , MD, vice president, Clinical Development and Medical Affairs, Oncology, Boehringer Ingelheim Pharmaceuticals, Inc.  "Boehringer Ingelheim is looking forward to contributing to the body of knowledge across multiple cancer types and patient groups through the presentation of data involving diverse investigational compounds from our growing oncology pipeline."

    Presentations of Boehringer Ingelheim Investigational Oncology CompoundsA full listing of the afatinib, nintedanib and volasertib abstracts included in the 2013 ASCO program is below: TitleAuthorsAbstract DetailsNintedanib*Safety and efficacy of nintedanib (BIBF 1120) plus pemetrexed in Japanese patients with advanced or recurrent non-small cell lung cancer (NSCLC): a phase I study

    Haruko Daga, MD

    PosterAbstract #: 8056

    Session: Lung Cancer – Non-small Cell Metastatic

    Date: Saturday, June 1

    Time: 8:00 - 11:45AM

    Location: S Hall A2

    Poster Board #: 34DPhase II trial of triple receptor tyrosine kinase receptor inhibitor nintedanib (BIBF 1120) in recurrent high-grade gliomas

    Andrew D. Norden, MD, MPH

    Poster

    Abstract #: TPS2104

    Session: Central Nervous System Tumors

    Date: Saturday, June 1

    Time: 8:00AM-11:45AM

    Location: S Hall A2

    Poster Board #: TBCPhase II efficacy and safety study of nintedanib vs sunitinib in previously untreated renal cell carcinoma (RCC) patients

    Tim Eisen, PhD, FRCP

    Oral presentation

    Abstract #: 4506

    Session: Genitourinary (Nonprostate) Cancer

    Date: Saturday, June 1

    Time: 3:00 – 3:15 PM

    Location: E Arie Crown TheaterLUME-Lung 2: A multicenter, randomized, double-blind, phase 3 study of nintedanib plus pemetrexed vs placebo plus pemetrexed in patients with advanced non-squamous non-small cell lung cancer (NSCLC) after failure of first-line chemotherapy

    Nasser Hanna, MD

    Poster Discussion

    Abstract #: 8034

    Session: Lung Cancer - Non-small Cell Metastatic

    Date: Sunday, June 2

    Time: 8:00AM - 12:00PM

    Location: E450b

    Poster Board #: 23

    Poster Discussion:

    Time: 11:30AM -12:30PM

    Location: E Hall D2Open-label, Phase I / randomized, Phase II trial of the triple angiokinase inhibitor, nintedanib, versus sorafenib in previously untreated patients with advanced hepatocellular carcinoma (HCC)

    Daniel H. Palmer, MRCP, PhD

    PosterAbstract #: TPS4160

    Session: Gastrointestinal (Noncolorectal) Cancer

    Date: Sunday, June 2

    Time: 8:00 - 11:45AM

    Location: S Hall A2

    Poster Board #: 33FNintedanib (BIBF 1120) + docetaxel in NSCLC patients progressing after one prior chemotherapy regimen: results of LUME-Lung 1, a randomized, double-blind, phase 3 trial

    Martin Reck, MD, PhD

     

    Oral Presentation

    Abstract #: LBA8011

    Session: Clinical Science Symposium: Targeted Therapies in Lung Cancer: What's New and What's Enough?

    Date: Monday, June 3

    Time: 10:45-11:00AM

    Location: E Hall D2Afatinib*LUX-Lung 6: Patient reported outcomes (PROs) from a randomized open-label, Phase III study in 1st-line advanced NSCLC patients (pts) harboring epidermal growth factor receptor (EGFR) mutations

    Sarayut L. Geater, MD, RCPT

    Poster

    Abstract #: 8061

    Session Title: Lung Cancer - Non-small Cell Metastatic

    Date: Saturday, June 1

    Time: 8:00 - 11:45AM

    Location: S Hall A2

    Poster Board #: 35APhase II study of afatinib, an irreversible ErbB Family Blocker, in demographically and genotypically defined non-small cell lung cancer (NSCLC) patients

    Jacques De Greve, MD, PhD

    Poster

    Abstract #: 8063

    Session Title: Lung Cancer - Non-small Cell Metastatic

    Date: Saturday, June 1

    Time: 8:00 - 11:45AM

    Location: S Hall A2

    Poster Board #: 35CLUX-Lung 6: A randomized, open-label, Phase III study of afatinib (A) vs gemcitabine/cisplatin (GC) as first-line treatment for Asian patients (pts) with EGFR mutation-positive (EGFR M+) advanced adenocarcinoma of the lung

    Yi-Long Wu, MD

    Poster Discussion

    Abstract #: 8016

    Session Title: Lung Cancer—Non-small Cell Metastatic

    Date: Sunday, June 2

    Time: 8:00 AM-12:00 PM

    Location: E450b

    Poster Board #: 5

    Poster Discussion:

    Time: 11:30 AM-12:30 PM

    Location: E Hall D2A randomized, open-label, Phase II study of afatinib vs cetuximab in patients (pts) with recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC): Analysis of Stage 2 (S2) following crossover

    Didier Cupissol, MD, PhD

    Oral Presentation

    Abstract #: 6001

    Session Title: Oral Abstract Session: Head and Neck Cancer

    Date: Sunday, June 2

    Time: 8:15 - 8:30AM

    Location: E354aA Phase I, dose-escalation trial of continuous and pulsed-dose afatinib (A) combined with pemetrexed (P) in patients (pts) with advanced solid tumors: Final analysis

    Quincy S-C Chu, MD

    Poster Discussion

    Abstract #: 2523

    Session Title: Developmental Therapeutics - Clinical Pharmacology and Experimental Therapeutics

    Date: Tuesday, June 4

    Time: 8:00AM - 12:00PM

    Location: E450a

    Poster Board #: 11

    Poster Discussion:

    Time: 11:30AM - 12:30PM

    Location: E354bVolasertib*Randomized phase II trial of the Polo-like kinase (Plk) inhibitor volasertib (V) versus investigator's choice chemotherapy in patients (pts) with platinum-resistant/refractory ovarian cancer (OC)

    Eric Pujade-Lauraine, MD, PhD

    Oral Presentation

    Abstract #: 5504

    Session: Gynecologic Cancer

    Date: Saturday, June 1

    Time: 4:15 – 4:30PM

    Location: E354b

     A phase I dose escalation study of volasertib (BI 6727) combined with nintedanib (BIBF 1120) in advanced solid tumors

    Filippo De Braud, MD

    Poster

    Abstract #: 2556

    Session: Developmental Therapeutics - Clinical Pharmacology and Experimental Therapeutics

    Date: Monday, June 3

    Time: 8:00 - 11:45AM

    Location: S Hall A2

    Poster Board #: 3HPhase I study of volasertib (BI 6727) combined with afatinib (BIBW 2992) in advanced solid tumors

    Marc Peeters, MD, PhD

    Poster Discussion

    Abstract #: 2521

    Session: Developmental Therapeutics- Clinical Pharmacology and Experimental Therapeutics

    Date: Tuesday, June 4

    Time: 8:00AM - 12:00PM

    Location: E450a

    Poster Board #: 9

    Poster Discussion:

    Time: 11:30AM -12:30PM

    Location: E354b*Afatinib, nintedanib and volasertib are investigational compounds; their safety and efficacy have not been established.About AfatinibAfatinib is an investigational, oral, once-daily irreversible ErbB Family Blocker that specifically inhibits epidermal growth factor receptor (EGFR or ErbB1), human epidermal receptor 2 (HER2 or ErbB2) and ErbB4. It is currently in Phase III clinical development in advanced NSCLC and head and neck cancer.  The company has submitted applications requesting the review of afatinib for patients with EGFR mutation-positive advanced NSCLC to regulatory authorities in a number of countries and regions worldwide, including the U.S., E.U. and Asia.

    Afatinib is not approved by the FDA; its safety and efficacy have not been established. 

    About NintedanibNintedanib (BIBF 1120) is an investigational orally-administered triple angiokinase inhibitor that targets three of the receptor tyrosine kinases shown to aid in the regulation of angiogenesis: fibroblast growth factor (FGF) receptor, platelet-derived growth factor (PDGF) receptor, and vascular endothelial growth factor (VEGF) receptor.

    Nintedanib is being evaluated in various solid tumors – including advanced NSCLC, ovarian cancer, liver cancer (hepatic cell carcinoma), kidney cancer (renal cell carcinoma) and colorectal cancer. The advanced NSCLC and ovarian cancer clinical trials are in Phase III development. Nintedanib is also being investigated in Phase III trials for the treatment of Idiopathic Pulmonary Fibrosis (IPF), a progressive and severely debilitating lung disease.

    Nintedanib is not approved by the FDA; its safety and efficacy have not been established. 

    About VolasertibVolasertib, an investigational inhibitor of polo-like kinase (Plk), is one of several late-stage compounds that Boehringer Ingelheim is currently evaluating in clinical trials for various solid tumors and hematological cancers. Boehringer Ingelheim is one of the first companies to advance Plk inhibitors into clinical development.

    Volasertib is designed to inhibit the activity of Plk1, an enzyme in the Plk family that regulates cell division (mitosis).  This inhibition is intended to result in prolonged cell cycle arrest, ultimately leading to cell death (apoptosis).[1]

    Volasertib is not approved by the FDA; its safety and efficacy have not been established.

    About Boehringer Ingelheim in OncologyBuilding on scientific expertise and excellence in the fields of pulmonary and cardiovascular medicine, metabolic disease, neurology, virology and immunology, Boehringer Ingelheim has embarked on a major research program to discover and develop innovative cancer treatments.  Working in close collaboration with the international scientific community and a number of the world's leading cancer centers, Boehringer Ingelheim's commitment to oncology is underpinned by using advances in science to develop a range of targeted therapies for various solid tumors and hematological cancers. The current focus of late-stage research includes compounds in three areas: signal transduction inhibition, angiogenesis inhibition and cell-cycle kinase inhibition. The company is also evaluating a robust and growing pipeline of early-stage oncology compounds in areas including growth/survival signaling, immunotherapy and epigenetics.

    For information about participating in a Boehringer Ingelheim clinical trial, please visit www.bicancertrials.com or call 1.866.725.7110. Healthcare providers interested in learning more about Boehringer Ingelheim clinical trials in oncology can visit www.inoncologyus.com for additional information. 

    About Boehringer Ingelheim Pharmaceuticals, Inc.Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.

    The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 140 affiliates and more than 46,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.

    As a central element of its culture, Boehringer Ingelheim has a demonstrated commitment to corporate social responsibility. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim's endeavors.

    In 2012, Boehringer Ingelheim achieved net sales of about $19.1 billion (14.7 billion euro). R&D expenditure in the business area Prescription Medicines corresponds to 22.5% of its net sales.

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

    References  [1]Schoffski P. Polo-Like Kinase (PLK) Inhibitors in Preclinical and Early Clinical Development in Oncology. Oncologist. 2009;14(6):559-570.
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    SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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