INGELHEIM, Germany, May 15 /PRNewswire/ --
-- For Non-US Media Only
-- Boehringer Ingelheim's LUX-Lung Programme Moves Forward With New Studies Revealing the Potential of BIBW 2992 in Personalising Lung Cancer Care
-- The First Presentation of Data From BIBF 1120 in Ovarian Cancer
Boehringer Ingelheim will present new data on the company's two lead oncology compounds, BIBW 2992(i) and BIBF 1120(ii) at the 2009 Annual Meeting of the American Society of Clinical Oncology (ASCO), the company announced today. Two studies in the LUX-Lung clinical development programme for BIBW 2992 and a Phase II study of BIBF 1120 in ovarian cancer patients will be Presented.
(i) (planned trade name Tovok(TM))
(ii) (planned trade name Vargatef(TM))
LUX Lung 2 interim results
Interim Phase II data from the LUX-Lung 2 study suggest BIBW 2992 has anti-tumour activity in advanced second-line non-small cell lung cancer (NSCLC) patients who have epidermal growth factor receptor (EGFR) mutations.(1)
"Lung cancer kills more people than any other cancer.(3) The LUX-Lung 1 and 2 studies represent an opportunity to investigate BIBW 2992 across a range of different patient populations," said Dr Manfred Haehl, Corporate Senior Vice President Medicine at Boehringer Ingelheim. "The preliminary data from the LUX-Lung 2 study suggests that BIBW 2992 may have activity in the second-line setting among NSCLC patients with EGFR mutations, which is encouraging news."(1) BIBW 2992 is an orally administered irreversible dual inhibitor of the epidermal growth factor receptor (EGFR) and human epithelial receptor 2 (HER2) tyrosine kinases.(4) It is the first irreversible EGFR-TKI (tyrosine kinase inhibitor) to reach Phase III for third/fourth-line NSCLC.(5)
In the emerging era of personalised cancer medicine, Boehringer Ingelheim is one of the first companies to prospectively identify appropriate patients for clinical trials based on biomarkers. As part of the LUX-Lung clinical development programme, Boehringer Ingelheim is evaluating BIBW 2992 in NSCLC patients who test positive for EGFR activating mutations.
"It is well documented that 'activating' mutations that arise in the tyrosine kinase (TK) domain of the EGFR gene are associated with an increased sensitivity to first generation EGFR TKIs.(6,7,8) The majority of patients who initially respond to EGFR TKIs such as gefitinib or erlotinib will eventually develop resistance, often through gaining another mutation, such as the so-called T790M resistance mutation,"(9,10) said Dr Haehl.
Detailed Findings from LUX-Lung 2:(1)
To date, 409 NSCLC patients have been screened in the LUX-Lung 2 study and 104 patients with EGFR mutations have started treatment with BIBW 2992 once daily. Preliminary data will be presented at ASCO for the first 73 second line patients, all of whom had previously received one regimen of chemotherapy. 67 patients are evaluable for response.
Interim data show: (1)
-- 64% of patients (43/67) taking BIBW 2992 in the 2nd line setting experienced a partial response (75% among patients with deletion 19 and 66% in patients with L858R mutations)
-- 31% (21/67) of patients taking BIBW 2992 in the 2nd line setting experienced stable disease
-- Median progression-free survival (PFS) in 2nd line setting is 10.2 months
-- The most common related adverse events were diarrhoea and skin-related disorders in 86% and 89% of patients respectively [16% and 18% being grade 3 respectively]
-- 37 patients had dose reduction and 4 patient discontinued treatment due to adverse events
Findings from LUX Lung 1
In addition, preliminary data on the demographic and blinded safety data from the ongoing Phase III study, the LUX-Lung 1 trial, will be presented at ASCO for the first time.(11)
The LUX-Lung 1 study addresses a critical need for treatment options for NSCLC patients after failure with a second-line or third-line reversible EGFR inhibitor (i.e. erlotinib or gefitinib). This study recently moved from Phase IIb into Phase III.(11)
"The LUX-Lung 1 study is important as it investigates BIBW 2992 in a Group of patients for whom there are no other approved treatment options. These are patients who have already been through standard first-line or second-line chemotherapy and then received treatment with an EGFR TKI. The LUX-Lung 1 study will evaluate whether BIBW 2992 will extend the lives of these cancer patients."(11) said Dr Haehl.
First presentation of Phase II data for BIBF 1120 in ovarian cancer
Data from a Phase II study of BIBF 1120 in patients with ovarian cancer who responded to at least second-line chemotherapy will be presented at ASCO in Orlando. The study showed a potential delay in disease progression: with BIBF 1120 the median time to RECIST progression was 4.8, and 2.8 for placebo.(2) BIBF 1120 is an oral compound that works by simultaneously inhibiting vascular endothelial growth factor receptors (VEGFRs), platelet-derived growth factor receptors (PDGFRs) and fibroblast growth factor receptors (FGFRs) - all factors which are crucially involved in the formation of blood vessels, a process known as angiogenesis.(12,13)
"There is a great need for more effective and well tolerated treatment options for women with ovarian cancer. We have a growing body of evidence that anti-angiogenic agents may represent an important treatment approach for this disease," commented Prof. Jonathan A Ledermann, MD, Professor of Medical Oncology & Director at the Cancer Research UK & UCL Cancer Trials Centre, University College London. "These data indicate BIBF 1120 may have a potential role in delaying disease progression in patients with ovarian cancer who had previously responded to chemotherapy."
Because angiogenesis plays a pivotal role in the growth of solid tumours,(13) BIBF 1120 is currently being investigated in a number of cancer types including advanced NSCLC. The LUME-Lung Phase III clinical trial programme is investigating BIBF 1120 in combination with standard second-line chemotherapy treatments for patients with advanced NSCLC. Approximately 2,600 patients will be enrolled, making this one of the largest Phase III study programmes in this NSCLC patient population to date.
For Non-US Journalists Only
Boehringer Ingelheim Oncology: A podcast update from ASCO 2009
Available from Saturday 16th May 2009
Visit http://www.personalisingcancercare.com to find out more about
Boehringer Ingelheim's compounds and watch experts Dr. James Spicer and
Dr. Rolf Kaiser discuss the significance of these exciting trial results.
Notes to editors
About Lung Cancer
Lung cancer is the world's most common cancer and kills more people than any other cancer. (3,14) In 2008, approximately 1.52 million new cases of lung cancer were diagnosed worldwide, with 1.31 million people dying from the disease.(14) In the United States, an estimated 161,840 deaths, accounting for 29 percent of all cancer deaths, occurred in 2008, according to the American Cancer Society (ACS).(15)
About Ovarian Cancer
According to the 2008 World Health Organization World Cancer Report, as of 2002, ovarian cancer was ranked as the 6th most common cancer in women. Additionally, approximately 204,000 new cases were diagnosed worldwide and 125,000 women died from the disease in 2002.(14) The ACS estimates that about 21,650 new cases of ovarian cancer were diagnosed in the United States (U.S.) during 2008. Only forty-five percent of women with ovarian cancer are still alive at least five years after diagnosis in the U.S.(16)
About Boehringer Ingelheim in Oncology
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