INGELHEIM, Germany - Thursday, May 17th 2012 [ME NewsWire]
(BUSINESS WIRE)-- Among the numerous abstracts being presented by Boehringer Ingelheim at the 48th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, June 1-5, 2012, the company will present results from the highly anticipated pivotal LUX-Lung 3 Phase III clinical trial. LUX-Lung 3 investigated afatinib*, and was the largest and most robust trial to date in first-line EGFR mutation positive, advanced, metastatic non-small cell lung cancer (NSCLC) patients,1 and the first study to use pemetrexed / cisplatin as a comparator.
The study results will shed light on a distinct and specific NSCLC patient population: those with EGFR mutations. EGFR mutations occur in 10-15% of Caucasian and 30-40% of Asian NSCLC patients 2and their presence is a well-established predictive biomarker that provides specific targets for therapeutic intervention in NSCLC. Early mutation testing for EGFR status is important to ensure patients have the opportunity to receive the appropriate personalised therapy immediately after they have been diagnosed with NSCLC.
LUX-Lung 3 ASCO oral presentation information:
Title
Lead Author
Presentation details
LUX-Lung 3: A randomized, open-label, Phase III study of afatinib versus pemetrexed and cisplatin as first-line treatment for patients with advanced adenocarcinoma of the lung harbouring EGFR-activating mutations.
James Chih-Hsin Yang, MD, PhD
Oral Abstract #LBA7500
Date: Monday, June 4 Time: 3:00-3:15 PM CDT
Pemetrexed/cisplatin
“The Annual Meeting of the American Society of Clinical Oncology will be the first time that data from the pivotal LUX-Lung 3 trial will be presented and we are looking forward to the scientific exchange”, said Mehdi Shahidi , M.D., Global Clinical Development Team Leader, Oncology, Boehringer Ingelheim. “The results will be particularly important for EGFR mutation positive patients and underline our commitment to advance personalised care for lung cancer patients”.
Boehringer Ingelheim has initiated two further trials, LUX-Lung 7 and 8, to assess the potential benefit of afatinib* in a head-to-head comparison with erlotinib (in advanced squamous cell carcinoma of the lung) and gefitinib, respectively, in EGFR mutation positive adenocarcinoma of the lung.
Additional Presentations of Boehringer Ingelheim Investigational Compounds
In addition to the LUX-Lung 3 presentation, more than 15 studies assessing Boehringer Ingelheim’s investigational therapies have been selected for presentation at ASCO, demonstrating the company’s strong and ongoing commitment to deliver innovative cancer therapies to patients across a variety of cancer types.
Select Poster Presentations
Title
Lead Author
Poster details
Afatinib*
Data Abstracts
Interim analysis of afatinib monotherapy in patients with metastatic NSCLC progressing after chemotherapy and erlotinib/gefitinib (E/G) in a trial of afatinib plus paclitaxel vs. investigator’s choice chemotherapy following progression on afatinib monotherapy
Martin H. Schuler, MD
Abstract # PS7557
Poster # 9826
Date: Saturday, June 2
Time: 1:15 – 5:15 PM CDT
Afatinib monotherapy in patients with metastatic squamous cell carcinoma of the lung progressing after erlotinib/gefitinib (E/G) and chemotherapy: Interim subset analysis from a phase III trial
Joo-Hang Kim, MD
Abstract # PS7558
Poster # 9825
Date: Saturday, June 2
Time: 1:15 – 5:15 PM CDT
A neoadjuvant, randomized, open-label phase II trial of afatinib (A) vs. trastuzumab (T) vs. lapatinib (L) in patients (pts) with locally advanced HER2-positive breast cancer (BC).
Mothaffar F. Rimawi, MD
Abstract # PS606
Poster # 9823
Date: Saturday, June 2
Time: 8:00 AM - 12:00 PM CDT
Trial In Progress Abstracts
LUX-breast 1: A randomized, phase III trial of afatinib and vinorelbine versus trastuzumab and vinorelbine in patients with HER2-overexpressing metastatic breast cancer (MBC) failing one prior trastuzumab treatment.
Nadia Harbeck, MD, PhD
Abstract #TPS649
Poster #15D
Date: Saturday, June 2 Time: 8:00 AM - 12:00 PM CDT
LUX-breast 2: A Phase II, open-label study of oral afatinib in HER2-overexpressing metastatic breast cancer (MBC) patients (pts) who progressed on prior trastuzumab (T) and/or lapatanib (L).
Tamas Hickish, MD
Abstract # TPS651
Poster #15F
Date: Saturday, June 2 Time: 8:00 AM - 12:00 PM CDT
LUX-breast 3: A randomised phase II study of afatinib alone or with vinorelbine versus investigator’s choice of treatment in patients (pts) with HER2-positive breast cancer (BC) with progressive brain metastases (BM) after trastuzumab or lapatinib-based therapy.
Heikki Joensuu, MD, Professor
Abstract #TPS647
Poster #15B
Date: Saturday, June 2 Time: 8:00 AM - 12:00 PM CDT
LUX-head and neck 1: A phase III, randomized trial of afatinib versus methotrexate (MTX) in patients (pts) with recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) who progressed after platinum-based therapy.
Jean-Pascal H. Machiels, MD, PhD
Abstract # PS5598
Poster #32H
Date: Saturday, June 2
Time: 1:15 – 5:15 PM CDT
LUX head and neck 2: A randomized, double-blind, placebo-controlled, phase III study of afatinib as adjuvant therapy after chemoradiation in primarily unresected, clinically high-risk, head and neck cancer patients.
Barbara Burtness, MD
Abstract # TPS5599
Poster # 33A
Date: Saturday, June 2
Time: 1:15 – 5:15 PM CDT
Nintedanib*
TRICC-c: BIBF 1120 versus placebo in patients receiving oxaliplatin plus fluorouracil and leucovorin (mFOLFOX6) for advanced, chemorefractory metastatic colorectal cancer (mCRC)—A multicenter, randomized phase II trial in progress.
Andreas Berger, MD
Abstract # TPS3636
Poster # 39A
Date: Monday, June 4 Time: 8:00 AM - 12:00 PM CDT
Volasertib*
Phase I trial of the polo-like kinase (Plk) inhibitor volasertib (BI 6727) combined with cisplatin or carboplatin in patients with advanced solid tumors.
Herlinde Dumez
Abstract # 3018
Poster #10
Date: Saturday, June 2
Time: 1:15 – 5:15 PM CDT
Notes to Editors
About Lung Cancer
Lung cancer is the most common and most deadly form of cancer in the world: it accounts for 1.6 million new cancer cases annually. Because of its poor prognosis, 1.38 million deaths each year are attributable to lung cancer.3 Overall, lung cancer is the cause of 18% of all cancer deaths.3 Thirteen percent of all new cases of cancer are lung cancers4 and smoking is attributed as the main cause.5
About Afatinib*
Afatinib* is an irreversible ErbB Family Blocker which inhibits signal transduction of all kinase receptors from the ErbB Family2, which is known to play a critical role in the growth and spread of the most pervasive cancers and cancers associated with high mortality (lung, breast, and head & neck cancers). A mutation of the Epidermal Growth Factor Receptor (EGFR, also referred to as ErbB1) is found in 10-15% of Caucasian and in 30-40% of Asian NSCLC patients2.
About the Afatinib* Clinical Trial Program
The LUX-Lung studies evaluate the use of afatinib* in various settings of advanced NSCLC, including in patients harbouring EGFR mutations and those with recurrent disease. These trials include:
LUX-Lung 1, a Phase IIb/III trial investigating afatinib plus best supportive care (BSC) versus placebo plus BSC in NSCLC patients who were previously treated with first-line chemotherapy and the reversible EGFR TKIs erlotinib or gefitinib. This trial is complete and no longer recruiting.
LUX-Lung 2, a Phase II trial evaluating afatinib in NSCLC patients with EGFR mutations (EGFR M+), either treatment-naïve or after one line of treatment with chemotherapy. This trial is complete and no longer recruiting.
LUX-Lung 3, a Phase III trial investigating afatinib as a first-line treatment in patients with advanced NSCLC with EGFR mutations. This trial is complete and no longer recruiting.
LUX-Lung 4, a Phase I/II trial of afatinib in NSCLC patients who have progressed after conventional EGFR-TKI treatment. This trial is ongoing, but no longer recruiting.
LUX-Lung 5, a global Phase III trial in patients previously treated with erlotinib or gefitinib and chemotherapy. This is the first randomized Phase III trial investigating whether patients who initially benefit from treatment with afatinib alone may further benefit from afatinib beyond progression when given in combination with chemotherapy. This trial is ongoing, but no longer recruiting.
LUX-Lung 6, a Phase III trial investigating the efficacy and safety of afatinib compared to standard chemotherapy for first-line treatment of NSCLC patients with EGFR mutations. This trial is ongoing, but no longer recruiting.
LUX-Lung 7, a Phase IIb trial evaluating afatinib head-to-head versus gefitinib as a first-line treatment in EGFR M+ NSCLC patients. Patient recruitment for this trial was recently initiated.
LUX-Lung 8, a Phase III trial evaluating afatinib head-to-head versus erlotinib in second-line treatment of squamous cell carcinoma of the lung. Patient recruitment for this trial was recently initiated.
For more information on these trials, please visit www.clinicaltrials.gov.
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 programme to develop innovative cancer drugs. Working in close collaboration with the international scientific community and a number of the world’s leading cancer centres, 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 haematological cancers.
The current focus of research includes compounds in three areas: angiogenesis inhibition, signal transduction inhibition and cell-cycle kinase inhibition. Nintedanib* (BIBF 1120) is currently in Phase III clinical development in NSCLC and ovarian cancer. Afatinib* is currently in Phase III clinical development in NSCLC, breast cancer and head and neck cancer. In the area of cell-cycle kinase inhibition, Boehringer Ingelheim is developing an inhibitor of polo-like kinase 1 (Plk1), volasertib*, a protein that is involved in the processes of cell division. The compound is in Phase II development for acute myelogenous leukemia.
Boehringer Ingelheim’s oncology pipeline is evolving and demonstrates the company’s continued commitment to the disease area.
Boehringer Ingelheim
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 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 endeavours.
In 2011, Boehringer Ingelheim achieved net sales of about 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: www.boehringer-ingelheim.comand www.thewhiteroom.info
References
1 Abstract no: LBA7500, LUX-lung 3: A randomized, open-label, phase III study of afatinib versus pemetrexed and cisplatin as first-line treatment for patients with advanced adenocarcinoma of the lung harboring EGFR-activating mutations. Oral Presentation at 48th Annual Meeting of the American Society of Clinical Oncology (ASCO) 2012.
2 Jang, T.W. et al. 2009. EGFR and KRAS Mutations in Patients With Adenocarcinoma of the Lung. The Korean Journal of Internal Medicine, March; 24(1), pp.48–54.
3Ferlay J et al. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer 2010; EPub Ahead of print.
4Cancer Research UK. UK lung cancer incidence. CancerStats – Key Facts 2009. [Online] Available at: http://info.cancerresearchuk.org/cancerstats/types/lung/incidence/[Last Accessed April 2009].
5Allen J et al. J Natl Compr Canc Netw 2008;6(3): 285-293.
* Afatinib, nintedanib (BIBF 1120) and volasertib are investigational compounds. Their safety and efficacy have not yet been fully established.
Contacts
Boehringer Ingelheim
Corporate Communications
Media + PR
Julia Meyer-Kleinmann
Phone: +49 6132 – 77 8271
Fax: +49 6132 – 77 6601
Email: press@boehringer-ingelheim.com
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