RIDGEFIELD, Conn., May 31, 2015 /PRNewswire/ -- Boehringer Ingelheim today announced overall survival (OS) results from the LUX-Lung 8 trial (NCT01523587) that directly compared the efficacy and safety of two EGFR-directed treatments, afatinib and erlotinib, in patients with advanced squamous cell carcinoma (SCC) of the lung, progressing after treatment with first-line chemotherapy. Treatment with afatinib significantly reduced the risk of death by 19%, extending the survival of patients to a median of 7.9 months compared to 6.8 months on erlotinib. Significantly more patients treated with afatinib were still alive at one year compared to those treated with erlotinib (36.4 vs. 28.2%). The details of the OS analysis (abstract #8002; oral presentation on Sunday, May 31 from 8:24 – 8:36 a.m. CDT in N Hall B1) will be presented today at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.
The complete results from this study will be the basis for global regulatory submissions later this year. Afatinib is not approved for use in patients with SCC of the lung.
OS was the key secondary endpoint of this randomized Phase III head-to-head trial, and was analyzed following positive results for the primary endpoint of progression-free survival (PFS) presented in 2014. The updated analysis of PFS confirmed a significant reduction in the risk of cancer progression by 19% in patients treated with afatinib compared with erlotinib. The delay in cancer progression seen with afatinib treatment was accompanied by improved control of cancer-related symptoms: a higher proportion of patients treated with afatinib reported improvement in cough (43.4 vs. 35.2%), shortness of breath (51.3 vs. 44.1%) and overall well-being/quality of life (35.7 vs. 28.3%) compared with erlotinib.
LUX-Lung 8 clinical trial investigator Shirish Gadgeel, M.D., leader of the Thoracic Oncology Multidisciplinary Team at the Karmanos Cancer Center, President of the Medical Executive Committee of the Karmanos Cancer Center, Detroit, commented: "In this study, afatinib showed superior overall survival compared to erlotinib, an accepted standard treatment for patients with squamous cell carcinoma of the lung. Furthermore, a significant delay in lung cancer progression was observed with afatinib, and patients reported improvement in cancer-related symptoms and overall quality of life."
The rate of severe adverse events was similar between afatinib and erlotinib treatment arms (57.1 vs. 57.5%). A higher incidence of severe diarrhea and stomatitis (mouth sores) was observed with afatinib compared to erlotinib (grade 3/4 diarrhea: 9.9/0.5 vs. 2.3/0.3%, grade 3 stomatitis: 4.1 vs. 0.0%), while a higher incidence of severe rash/acne was reported with erlotinib compared to afatinib (grade 3 rash/acne: 10.4 vs. 5.9%). See abstract #8002 for full details.
Tunde Otulana, M.D., senior vice president, Clinical Development and Medical Affairs, Boehringer Ingelheim, commented: "With these positive overall survival results, we will pursue global regulatory submissions for the treatment of afatinib in patients with squamous cell carcinoma of the lung. We are proud to be conducting research on afatinib that may ultimately expand treatment options for patients with this devastating disease."
Non-small cell lung cancer (NSCLC) is the most common form of lung cancer comprising over 85% of lung cancer cases. SCC, a type of lung cancer which develops in the cells lining the airways, represents approximately 30% of NSCLC cases. Treatment options are limited and SCC of the lung is associated with a poor prognosis, with less than 5% of patients with advanced SCC surviving for five years or longer.
LUX-Lung 8 was conducted across 23 countries and is the first prospective trial to compare two different tyrosine kinase inhibitors (TKIs) in patients with advanced SCC of the lung (n=795).
Afatinib is approved in more than 50 countries for the first-line treatment of distinct types of EGFR mutation-positive NSCLC (under the brand names: GIOTRIF® / GILOTRIF®). Approval of afatinib in this indication was based on the primary endpoint of PFS from the LUX-Lung 3 clinical trial where afatinib significantly delayed tumor growth when compared to standard chemotherapy. In addition, afatinib is the first treatment to show an OS benefit for patients with specific types of EGFR mutation-positive NSCLC compared to chemotherapy. A significant OS benefit was demonstrated independently in the LUX-Lung 3 and 6 trials for patients with the most common EGFR mutation (exon 19 deletions; del19) compared to chemotherapy.
About Gilotrif® (afatinib) tablets
GILOTRIF is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test.
Limitation of Use: Safety and efficacy of GILOTRIF have not been established in patients whose tumors have other EGFR mutations.
GILOTRIF is an oral, once-daily kinase inhibitor that is designed to irreversibly bind and inhibit the following receptors: EGFR (ErbB1), HER2 (ErbB2) and ErbB4.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Bullous and Exfoliative Skin Disorders
Interstitial Lung Disease (ILD)
Effect of P-glycoprotein (P-gp) Inhibitors and Inducers
USE IN SPECIFIC POPULATIONS
For full prescribing information, including patient information, please click here. You can also visit www.gilotrif.com or contact Boehringer Ingelheim's Medical and Technical Information (MTI) Unit at 1-800-542-6257
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.
About Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation.
Boehringer Ingelheim is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, the company operates globally with 146 affiliates and more than 47,000 employees. Since its founding in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel treatments for human and veterinary medicine.
Boehringer Ingelheim is committed to improving lives and providing valuable services and support to patients and families. Our employees create and engage in programs that strengthen our communities. To learn more about how we make more health for more people, visit our Corporate Social Responsibility Report.
In 2014, Boehringer Ingelheim achieved net sales of about $16.96 billion dollars (13.3 billion euros). R&D expenditure corresponds to 19.9 percent of its net sales.
For more information please visit www.us.boehringer-ingelheim.com, or follow us on Twitter @BoehringerUS.
Boehringer Ingelheim Pharmaceuticals, Inc.
Name: Paul Wynn
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/asco-2015-superior-overall-survival-for-afatinib-compared-to-erlotinib-demonstrated-in-head-to-head-trial-in-patients-with-previously-treated-advanced-squamous-cell-carcinoma-of-the-lung-300090565.html
SOURCE Boehringer Ingelheim