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Boehringer Ingelheim to present pivotal Phase III results for afatinib in first-line treatment of EGFR mutation-positive NSCLC at ASCO 2012

May 16, 2012

RIDGEFIELD, Conn., May 16, 2012 /PRNewswire/ — Boehringer Ingelheim will present results from LUX-Lung 3, the company’s pivotal Phase III clinical trial investigating afatinib in patients with stage IIIB or IV non-small cell lung cancer (NSCLC) harboring an epidermal growth factor receptor (EGFR) mutation (EGFR M+), at the 48th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, June 1-5, 2012. LUX-Lung 3, which compares the investigational oral, once-daily therapy, afatinib, to pemetrexed/cisplatin, is the largest Phase III trial to date in first-line EGFR mutation-positive, advanced, metastatic NSCLC patients, and the first to use pemetrexed/cisplatin as a comparator in this population.

The presentation of the LUX-Lung 3 trial will shed light on a distinct and specific NSCLC patient population, those with EGFR mutations. EGFR mutations occur in 10 to 15 percent of NSCLC patients, and are well-established predictive biomarkers that provide specific targets for therapeutic intervention in NSCLC.

    Title                   Lead Author            Presentation details
    -----                   -----------            --------------------
    LUX-Lung 3: A            James Chih-Hsin Yang,
     randomized,             MD, PhD               Oral Abstract #LBA7500
    open-label, phase III
     study of                                      Date: Monday, June 4
    afatinib versus
     pemetrexed and                                Time: 3:00 PM-3:15 PM CDT
    cisplatin as first-line
     treatment for
    patients with advanced
    adenocarcinoma of the
     lung
    harboring EGFR-
     activating mutations.

“We are excited to share the results of our pivotal LUX-Lung 3 trial, the largest and most robust ever conducted in EGFR mutation-positive patients,” said Berthold Greifenberg, M.D., Vice President, Clinical Development and Medical Affairs, Oncology, Boehringer Ingelheim Pharmaceuticals, Inc. “We are continuously advancing the development of our oncology pipeline and look forward to opportunities to contribute to the body of scientific knowledge in this area.”

Additional Presentations of Boehringer Ingelheim Investigational Compounds

In addition to the LUX-Lung 3 presentation, more than 15 studies of Boehringer Ingelheim’s investigational therapies have been selected for inclusion at ASCO, demonstrating the company’s innovative clinical development program across a variety of cancer types.

    Select Poster
     Presentations
    --------------
    Title                Lead Author               Poster details
    -----                -----------               --------------
    Afatinib
    --------
    LUX-breast 3:         Heikki Joensuu, MD,
     Randomized phase     Professor
     II study of                                   Abstract #TPS647
    afatinib alone or
     with vinorelbine
     versus                                        Poster #15B
    investigator's
     choice of
     treatment in
     patients (pts)                                Date: Saturday, June 2
    with HER2-positive                              Time: 8:00 AM -12:00 PM
     breast cancer                                  CDT
     (BC) with
    progressive brain
     metastases (BM)
     after
    trastuzumab or
     lapatinib-based
     therapy.

    LUX-breast 1:
     Randomized, phase
     III trial of        Nadia Harbeck, MD, PhD    Abstract #TPS649
    afatinib and
     vinorelbine
     versus
     trastuzumab and                               Poster #15D
    vinorelbine in
     patients with
     HER2-overexpressing                           Date: Saturday, June 2
    metastatic breast                               Time: 8:00 AM -12:00 PM
     cancer (MBC)                                   CDT
     failing one prior
    trastuzumab
     treatment.

    LUX-breast 2:
     Phase II, open-
     label study of
     oral                Tamas Hickish, MD         Abstract # TPS651
    afatinib in
     HER2-overexpressing
     metastatic breast                             Poster #15F
    cancer (MBC)
     patients (pts)
     who progressed on                             Date: Saturday, June 2
    prior trastuzumab                               Time: 8:00 AM -12:00 PM
     (T) and/or                                     CDT
     lapatanib (L).

    LUX-head and neck     Jean-Pascal H. Machiels,
     1: A phase III,      MD, PhD
     randomized                                    Abstract # PS5598
    trial of afatinib
     versus
     methotrexate
     (MTX) in                                      Poster #32H
    patients (pts)
     with recurrent/
     metastatic (R/M)                              Date: Saturday, June 2
    head and neck
     squamous cell
     carcinoma (HNSCC)                             Time: 1:15 - 5:15 PM CDT
    who progressed
     after platinum-
     based therapy.

    LUX-head and neck
     2: A randomized,
     double-             Barbara Burtness, MD      Abstract # TPS5599
    blind, placebo-
     controlled, phase
     III study of                                  Poster # 33A
    afatinib as
     adjuvant therapy
     after
     chemoradiation                                Date: Saturday, June 2
    in primarily
     unresected,
     clinically high-
     risk, head                                    Time: 1:15 - 5:15 PM CDT
    and neck cancer
     patients.
    ---------------
    Nintedanib
    ----------
    TRICC-c: BIBF
     1120 versus
     placebo in
     patients            Andreas Berger, MD        Abstract # TPS3636
    receiving
     oxaliplatin plus
     fluorouracil and                              Poster # 39A
    leucovorin
     (mFOLFOX6) for
     advanced,                                     Date: Monday, June 4
    chemorefractory                                 Time: 8:00 AM -12:00 PM
     metastatic                                     CDT
     colorectal cancer
    (mCRC)-A
     multicenter,
     randomized phase
     II trial
    in progress.
    Volasertib
    Phase I trial of
     the polo-like
     kinase (Plk)
     inhibitor           Herlinde Dumez            Abstract # 3018
    volasertib (BI
     6727) combined
     with cisplatin or                             Poster #10
    carboplatin in
     patients with
     advanced solid                                Date: Saturday, June 2
    tumors.                                        Time: 1:15 - 5:15 PM CDT

About Lung Cancer

Lung cancer is the second most common cancer and kills more people than any other cancer. In 2012, approximately 226,160 new cases of lung cancer will be diagnosed in the United States, with 160,340 Americans dying from the disease. NSCLC is the most common form, accounting for about 85 percent of all lung cancers.[1] Lung cancer remains an area of high unmet need, especially in its advanced stages where it is particularly aggressive and patients have limited treatment options.

About Afatinib

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

Afatinib 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), ErbB3 and ErbB4. It is currently in phase III clinical development in NSCLC, head and neck and breast cancer.

About the Afatinib Clinical Trial Program in Advanced NSCLC

The LUX-Lung studies evaluate the use of afatinib in various settings of advanced NSCLC, including in patients harboring EGFR mutations and those with recurrent disease. These trials include:

  • LUX-Lung 1, a Phase IIb/III trial investigating afatinib plus best supportive care (BSC) versus placebo plus BSC in NSCLC patients who were previously treated with first-line chemotherapy and the reversible EGFR TKIs erlotinib or gefitinib.
  • LUX-Lung 2, a Phase II trial evaluating afatinib in NSCLC patients with EGFR mutations (EGFR M+), either treatment-naive or after one line of treatment with chemotherapy.
  • LUX-Lung 3, a Phase III trial investigating afatinib as a first-line treatment in patients with advanced NSCLC with EGFR mutations.
  • LUX-Lung 4, a Phase I/II trial of afatinib in NSCLC patients who have progressed after conventional EGFR-TKI treatment.
  • LUX-Lung 5, a global Phase III trial in patients previously treated with erlotinib or gefitinib. This is the first randomized Phase III trial investigating whether patients who initially benefit from treatment with afatinib alone may further benefit from afatinib beyond progression when given in combination with chemotherapy.
  • LUX-Lung 6, a Phase III trial investigating the efficacy and safety of afatinib compared to standard chemotherapy for first-line treatment of NSCLC patients with EGFR mutations.
  • LUX-Lung 7, a Phase IIb trial evaluating afatinib head-to-head versus gefitinib as a first-line treatment in EGFR M+ NSCLC patients. Patient recruitment for this trial has recently initiated.
  • LUX-Lung 8, a Phase III trial evaluating afatinib head-to-head versus erlotinib in second-line treatment of squamous cell carcinoma of the lung. Patient recruitment for this trial has recently initiated.

For more information on these trials, please visit www.clinicaltrials.gov.

About Boehringer Ingelheim in Oncology

Building 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 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. Afatinib is an investigational orally-administered irreversible inhibitor of the ErbB family of receptor tyrosine kinases, which is currently in phase III clinical development in advanced NSCLC, head and neck cancer, and breast cancer. Nintedanib (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 and is currently in phase III clinical development in NSCLC and ovarian cancer. Volasertib is an investigational inhibitor of polo-like kinase that is currently being investigated in early phase trials. Boehringer Ingelheim’s oncology pipeline continues to evolve and demonstrates the company’s continued commitment to the disease area.

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 145 affiliates and more than 44,000 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 2011, Boehringer Ingelheim achieved net sales of about $17.1 billion (13.2 billion euro). R&D expenditure in the business area Prescription Medicines corresponds to 23.5% of its net sales.

For more information, please visit http://us.boehringer-ingelheim.com and follow us on Twitter at http://twitter.com/boehringerus.

References

[1] American Cancer Society. Cancer Facts and Figures: 2012. Available at: http://www.cancer.org/acs/groups/content/@epidemiologysurveilance/documents/document/acspc-031941.pdf. Last accessed April 27, 2012.

SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.


Source: PR Newswire