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New Boehringer Ingelheim Data To Be Presented On Health-Related Quality Of Life With Afatinib In Patients With EGFR Mutation-Positive Advanced NSCLC

has announced new patient-reported health-related outcomes for its investigational oncology compound afatinib,* including -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 (pemetrexed/cisplatin) (n=115) in patients with epidermal growth factor receptor () mutation-positive advanced non-small cell lung cancer (NSCLC). The poster was presented at the ESMO 2012 Congress () on Sunday, September 30 at 6:45 – 8:15 a.m. ET.

According to the abstract, three – 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.[i]

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.[ii] 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.

Source

[i] Sequist, 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.

[ii] The 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.

*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 http://www.bicancertrials.com or call 1.866.725.7110. Healthcare providers interested in learning more about Boehringer Ingelheim clinical trials in oncology can visit http://www.inoncologyus.com for additional information.

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