More Proof Lung Cancer is Not One Disease: New Investigational Treatment, Nintedanib* Plus Chemotherapy, Extends Life of Lung Cancer Patients With Adenocarcinoma

 

Burlington, ON – June 3, 2013

New research on Canada’s number one cancer killer[i] is further proof that patients need personalized treatments targeted to their specific type of lung cancer for better outcomes. Boehringer Ingelheim (Canada) Ltd. today announced highly anticipated results from the Phase III LUME-Lung 1 study in patients with advanced non-small cell lung cancer (NSCLC).The primary endpoint was progression-free survival (PFS) and the results showed patients treated with nintedanib plus chemotherapy (docetaxel) lived for a median of 3.4 months before their tumour started to grow again, versus 2.7 months with docetaxel alone (HR 0.79; p=0.0019).[ii]The study also examined the secondary endpoint of overall survival (OS),2 and in the process uncovered a specific group of patients who respond particularly well to the combination therapy.

The trial examined a sub-group of patients with adenocarcinoma histology – the most common type of NSCLC.[iii]It showed that patients with adenocarcinoma whose disease progressed during first-line therapy or shortly after lived for an additional 2.3 months in the nintedanib combination treatment arm versus with docetaxel alone. Specifically, the median overall survival (the gold standard measure of success in lung cancer treatment) was 12.6 months in the nintedanib combination treatment arm versus 10.3 months with docetaxel alone (HR 0.75; p=0.0073).2

“These study results are significant because they show us that nintedanib may become an interesting option for some subsets of patients with lung cancer,” says Dr. Normand Blais, medical oncologist at the Centre Hospitalier de l’Université de Montréal (CHUM) in Montreal. “This is big news for the lung cancer community because patients progressing after a first-line treatment need more efficient treatments to control their cancers. As an oncologist I want to offer my patients the best treatment options available and it is encouraging to see new options in development that may help us devise more efficacious and individualized treatment approaches.”

“Personalized medicine has changed the face of lung cancer treatment and we now know lung cancer is not just one disease, so we need to consider this when conducting new research,” said Dr. Mathias Knecht M.D., Vice President Medical and Regulatory Affairs, Boehringer Ingelheim (Canada) Ltd. “For this reason Boehringer Ingelheim is investigating two drugs for NSCLC – afatinib* and nintedanib* – both which address the unmet needs of two distinct lung cancer patient populations. These most recent nintedanib results represent some of the latest advancements from Boehringer Ingelheim’s robust oncology pipeline.”

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,[iv] 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).2

The primary endpoint was PFS; results showed patients treated with nintedanib plus docetaxel lived for a median of 3.4 months before their tumour started to grow again, versus 2.7 months with docetaxel alone (HR 0.79; p=0.0019).2

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.3 Overall survival was evaluated in the following sequence: patients with adenocarcinoma histology whose disease progressed during first-line therapy or shortly after (less than 9 months since the start of first-line therapy); all patients with adenocarcinoma histology; and, all study participants (full study population). In the group of patients with adenocarcinoma histology whose disease progressed during first-line therapy or shortly after, the median OS was 10.9 months in the nintedanib combination treatment arm versus 7.9 months with docetaxel alone (HR: 0.75; p=0.0073).2 In all 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).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).2

The most common adverse events (AEs) in LUME-Lung 1 were gastrointestinal side effects and liver enzyme elevations which were manageable by supportive treatment or dose reduction (adverse events placebo vs. nintedanib: nausea 18 per cent vs. 24 per cent, vomiting 9 per cent vs. 17 per cent, diarrhoea 22 per cent vs. 42 per cent and liver enzymes 8 per cent vs. 29 per cent).2

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 per cent of all diagnoses.[v] Adenocarcinoma is the most common type of NSCLC, accounting for 40 per cent of all NSCLC diagnoses.3

About Lung Cancer in Canada

According to the Canadian Cancer Society, in 2012 an estimated 25,600 Canadians were diagnosed with lung cancer,[vi] and 20,100 died from it.[vii] In fact, more people were estimated to die from lung cancer in 2012 than from colorectal, breast and prostate cancer combined.[viii] As the leading cause of cancer death in both men and women in Canada,[ix] its estimated an average of 55 Canadians die from lung cancer every day.[x]

Lung cancer is also grossly under researched and under-funded. It only gets 7 per cent of cancer-specific research funding and 0.1 per cent of cancer donations, despite the fact that it causes 27 per cent of cancer-related deaths.[xi]

Notes to Editors:

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 tumours – including advanced non-small cell lung cancer (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 Health Canada; 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 tumours 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.

About Boehringer Ingelheim (Canada) Ltd.

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 pledges to act socially responsible. 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 14.7 billion euro. R&D expenditure in its Prescription Medicines business corresponds to 22.5% of its net sales.

The Canadian headquarters of Boehringer Ingelheim was established in 1972 in Montreal, Quebec and is now located in Burlington, Ontario. Boehringer Ingelheim employs more than 550 people across Canada. For more information please visit www.boehringer-ingelheim.ca.

For more information, please contact:

Morgan Cates

Environics Communications

416-969-2789

mcates@environicspr.com