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

For U.S. Media Only

- Three of the company's investigational compounds, each with a different mechanism of action, will be included in 14 abstracts

- Four abstracts accepted for oral presentation - spanning advanced non-small cell lung cancer, renal cell carcinoma, head and neck squamous cell carcinoma and ovarian cancer

News provided by

Boehringer Ingelheim Pharmaceuticals, Inc.

May 15, 2013, 06:00 ET

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 49^th 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 Compounds

A full listing of the afatinib, nintedanib and volasertib abstracts included in the 2013 ASCO program is below:

Title	Authors	Abstract Details
Nintedanib*
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	Poster Abstract #: 8056 Session: Lung Cancer – Non-small Cell Metastatic Date: Saturday, June 1 Time: 8:00 - 11:45AM Location: S Hall A2 Poster Board #: 34D
Phase 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 #: TBC
Phase 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 Theater
LUME-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 D2
Open-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	Poster Abstract #: TPS4160 Session: Gastrointestinal (Noncolorectal) Cancer Date: Sunday, June 2 Time: 8:00 - 11:45AM Location: S Hall A2 Poster Board #: 33F
Nintedanib (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 D2
Afatinib*
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 #: 35A
Phase 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 #: 35C
LUX-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 D2
A 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: E354a
A 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: E354b
Volasertib*
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 #: 3H
Phase 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 Afatinib

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) 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 Nintedanib

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: 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 Volasertib

Volasertib, 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 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 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.

SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.