Primary Progression-Free Survival Endpoint Met in Phase III Study of Nintedanib Plus Docetaxel in Second-Line Advanced NSCLC

Ridgefield, CT, June 3, 2013 – Boehringer Ingelheim Pharmaceuticals, Inc.(BIPI) today announced results from the Phase III LUME-Lung 1 study showing that the addition of the investigational oncology compound nintedanib* to docetaxel improved progression-free survival (PFS) – the primary endpoint –as a second-line treatment in patients with advanced non-small cell lung cancer (NSCLC) compared to docetaxel alone.¹ Secondary endpoints included overall survival (OS).¹ These results will be presented today at the 49th Annual Meeting of the American Society of Clinical Oncology (ASCO).

“We are pleased to present the progression-free survival and overall survival data observed with the nintedanib/docetaxel combination in the LUME-Lung 1 clinical trial, in patients with advanced non-small cell lung cancer in the second-line treatment setting,” said Berthold Greifenberg, MD, vice president, Clinical Development and Medical Affairs, Oncology, Boehringer Ingelheim Pharmaceuticals, Inc. “These results were selected by ASCO for presentation at a late-breaking oral session at this year’s annual meeting.”

The trial enrolled 1,314 patients with advanced NSCLC whose disease progressed after first-line chemotherapy.¹ Patients were randomly assigned to receive nintedanib plus docetaxel (n=655), a standard second-line chemotherapy, or docetaxel plus placebo (n=659).¹

The primary endpoint was PFS as assessed by central independent review; results showed patients treated with nintedanib plus docetaxel lived for a median of 3.4 months before their tumor started to grow again, versus 2.7 months with docetaxel alone (HR 0.79; p=0.0019).¹

The secondary endpoint of OS was evaluated in the full study population, as well as in the sub-group of patients with adenocarcinoma histology – the most common type of NSCLC.² In the full study population, the median OS was 10.1 months in the nintedanib combination arm versus 9.1 months with docetaxel alone (HR 0.94; p=0.272).¹ In patients with adenocarcinoma histology, the median OS was 12.6 months in the nintedanib combination arm versus 10.3 months with docetaxel alone (HR: 0.83; p=0.0359).¹

The most common adverse events (AEs) of any grade in the nintedanib combination and docetaxel alone groups were diarrhea (42.3 vs. 21.8 percent, respectively) and ALT elevations (28.5 vs. 8.4 percent, respectively).¹ Incidence of ≥ grade 3 AEs was 71.3 percent in patients treated with nintedanib plus docetaxel compared to 64.3 percent with docetaxel alone.¹ A higher incidence of ≥ grade 3 diarrhea and elevated ALT were observed in patients treated with nintedanib plus docetaxel compared to docetaxel alone (≥ grade 3 diarrhea: 6.6 vs. 2.6 percent; elevated ALT: 7.8 vs. 0.9 percent).¹ Incidence of ≥ grade 3 hypertension, bleeding and thrombosis were similar in both treatment arms.¹ There was a one percent difference in discontinuation between the treatment arms with 22.7 percent of patients stopping treatment with nintedanib plus docetaxel versus 21.7 percent with docetaxel alone.¹

“Over the last ten years the understanding of lung cancer has evolved. At Boehringer Ingelheim, we understand that lung cancer is not just one disease and we are committed to designing trials and developing therapies across the lung cancer spectrum,” said William Goeckeler, PhD, director, Oncology Medical Affairs, Boehringer Ingelheim Pharmaceuticals, Inc.

About the LUME-Lung 1 Trial
LUME-Lung 1 (Clinical Trial Identifier: NCT00805194) is a randomized, open-label, double-blind Phase III study evaluating nintedanib plus docetaxel in patients with locally advanced or metastatic (stage IIIb/IV or recurring) non-small cell lung cancer (NSCLC) after prior first-line therapy, compared to docetaxel plus placebo. The study included 1,314 patients in Europe, Asia and South Africa,³ randomized to receive nintedanib 200 mg BID plus docetaxel 75mg/m² once a day, for three weeks (n=655) or docetaxel plus placebo (n=659).¹

LUME-Lung 1 is part of the wider Boehringer Ingelheim LUME-Lung Phase III program for nintedanib investigating the safety and efficacy of nintedanib in NSCLC patients after first-line chemotherapy treatment.

About Non-Small Cell Lung Cancer (NSCLC)
NSCLC is the most common form of lung cancer, accounting for about 85 percent of all diagnoses.⁴ Adenocarcinoma is the most common type of NSCLC, accounting for 40 percent of all NSCLC diagnoses.²

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 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.

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