Value through InnovationOctober 26 2014
September 28, 2012

New Boehringer Ingelheim data to be presented on health-related quality of life with afatinib in patients with EGFR mutation-positive advanced NSCLC

Patient-reported secondary endpoints from the LUX-Lung 3 trial will be presented at the ESMO 2012 Congress on Sunday, September 30

Poster: #1229PD
Presentation: Sunday, September 30; 6:45 – 8:15 AM ET
Poster Discussion Session: NSCLC, metastatic

Ridgefield, CT, September 28, 2012 – Boehringer Ingelheim today announced new patient-reported health-related outcomes for its investigational oncology compound afatinib,* including lung cancer-related symptoms and quality of life (QoL). These data are secondary endpoints of LUX-Lung 3, a Phase III trial of afatinib (n=230) compared to chemotherapy (pemetrexed/cisplatin) (n=115) in patients with epidermal growth factor receptor (EGFR) mutation-positive advanced non-small cell lung cancer (NSCLC). The poster will be presented at the ESMO 2012 Congress (European Society for Medical Oncology) on Sunday, September 30 at 6:45–8:15 a.m. ET.

According to the abstract, three lung cancer symptoms – cough, dyspnea (shortness of breath), and pain – were analyzed using the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire for lung cancer (QLQ-LC13). Results showed that a higher proportion of afatinib-treated patients had 10 point or more improvements in cough (67% vs. 60%; p=0.2444), dyspnea (64% vs. 50%; p=0.0103) and pain (59% vs. 48%; p=0.0513) compared with those treated with chemotherapy. Patients treated with afatinib also reported a delay in the worsening (time to deterioration) of their lung cancer-related symptoms – cough (HR=0.60; p=0.0072) and dyspnea (HR=0.68; p=0.0145) – compared with those treated with chemotherapy. The time to deterioration of pain was not significant between the treatment arms (HR=0.82; p=0.1913). Mean symptom scores over time significantly favored afatinib over chemotherapy for cough and dyspnea.1

Health-related QoL was measured using the EORTC QLQ-C30 questionnaire, which evaluated global health status/QoL (overall well-being) in addition to physical, cognitive, role, social and emotional functioning.2 Of these six measures, patients treated with afatinib experienced improvements in their global health-related quality of life and physical, cognitive and role functioning compared to chemotherapy (p<0.05).1

Consistent with the safety profiles of afatinib and cisplatin/pemetrexed, afatinib-treated patients reported worse scores for diarrhea, sore mouth and dysphagia; patients treated with cisplatin/pemetrexed reported worse scores for fatigue, nausea and vomiting.1

“Evaluating patient-reported outcomes in lung cancer, such as health-related quality of life, can help us understand a treatment’s impact beyond just following the size of the tumor,” said Lecia V. Sequist, MD, MPH, medical oncologist at Massachusetts General Hospital Cancer Center, assistant professor of medicine at Harvard Medical School, and one of the Principal Investigators for the LUX-Lung 3 trial.

“These health-related quality of life data, in addition to previously reported efficacy and safety data, provide important insight into the potential of afatinib for patients with EGFR mutation-positive advanced non-small cell lung cancer,” said Berthold Greifenberg, MD, vice president, Clinical Development and Medical Affairs, Oncology, Boehringer Ingelheim Pharmaceuticals, Inc.

In addition to these data, results from 12 additional abstracts of Boehringer Ingelheim’s investigational oncology compounds were selected for presentation at the ESMO 2012 Congress.

*Afatinib is an investigational compound; its efficacy and safety have not been established

Methodology for Measuring Patient-Reported Outcomes
Patient-reported outcomes were measured using European Organization for Research and Treatment of Cancer (EORTC) questionnaires (QLQ-C30 and QLQ-LC13) at baseline and then every three weeks until progression. Changes of 10 points or more were considered clinically significant. Analyses of cough, dyspnea and pain symptoms were pre-specified. Time to deterioration (first 10-point worsening from baseline) was analyzed using a stratified log-rank test. Percentage improved/worsened by 10 or more points or stable was measured. Mean scores over time were estimated using longitudinal (mixed-effects growth curve) models.1

About the LUX-Lung 3 Trial
The LUX-Lung 3 trial is a randomized, open-label, Phase III study comparing the investigational, oral, once-daily therapy, afatinib, to a combination chemotherapy regimen as first-line treatment for patients with stage IIIb or IV NSCLC harboring an EGFR mutation. The study randomly assigned 345 patients with EGFR mutation-positive advanced NSCLC to receive afatinib (n=230) or pemetrexed/cisplatin (n=115). The LUX-Lung 3 trial 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 primary endpoint was progression-free survival (PFS). Secondary endpoints of the LUX-Lung 3 trial included objective response, duration of responses, patient-reported outcomes (including quality of life), safety and overall survival.1

As previously reported, the study met its primary endpoint of PFS with afatinib versus chemotherapy (11.1 versus 6.9 months, respectively) in patients with EGFR mutation-positive advanced NSCLC. The most common drug-related adverse events observed with afatinib were diarrhea (95%), rash (62%), and paronychia (57%). The most common drug-related adverse events observed with chemotherapy (pemetrexed/cisplatin) were nausea (66%), decreased appetite (53%), and vomiting (42%).

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, head and neck and breast cancer. Afatinib is not approved by the FDA; its safety and efficacy have not been established. Boehringer Ingelheim recently submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of afatinib as a treatment for patients with EGFR (ErbB1) mutation-positive NSCLC. The company is working on applications for afatinib in a number of countries, including the United States.

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.

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

1Sequist, Lecia. V. MD, MPH, et al. LUX-Lung 3: Symptom and health-related quality of life results from a randomized phase III study in first-line advanced NSCLC patients harbouring EGFR mutations. [Abstract 1229PD] ESMO 2012 Congress (European Society for Medical Oncology), Vienna, Austria. September 30, 2012.
2The EORTC QLQ-C30. 3rd ed. Brussels: EORTC Data Center (2001). Available at: http://groups.eortc.be/qol/sites/default/files/img/slider/specimen_qlq-c30_english.pdf.

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