Boehringer Ingelheim has marked a new milestone within its rapidly expanding oncology portfolio with the progress of another oncology compounds into pivotal phase-III clinical development. The two studies, known as Lume-Lung 1 and Lume-Lung 2, for Vargatef (BIBF 1120), a triple angiokinase inhibitor1, will evaluate the molecule as a second-line therapy in combination with standard chemotherapy agents in patients with advanced non small- cell lung cancer (NSCLC), a patient population with limited treatment choices. This significant advance represents encouraging progress for the company across a portfolio that spans three key areas of focus: angiokinase inhibition, signal transduction inhibition and cell cycle kinase inhibition and further confirms its continued commitment to the field of oncology.

In addition, Boehringer Ingelheim's most advanced compound Tovok (BIBW 2992) will soon enter its second pivotal trial, Lux-Lung 3 in first-line NSCLC. Furthermore, a new compound and potentially first-in class-molecule, polo-like kinase-1 (Plk1) inhibitor, BI 6727, has demonstrated such positive phase-I results that it will be progressed to phase-II.

According to Dr Nasser Hanna, associate professor of Medicine in the Division of Oncology at Indiana University and principal investigator of one of the Lume Lung studies, the commencement of these trials heralds another stepping stone in the quest to combat the world's most common fatal malignancy. "While our battle to conquer cancer continues, lung cancer remains the leading cause of worldwide cancer deaths despite the availability of numerous therapeutic Seite 2 options. The need to develop newer, smarter therapies has never been so urgent," said Dr Hanna.

"The fact remains that one in two non-small cell lung cancer patients who receive treatment fail their initial therapies and remain well enough to receive additional options. The Lume-Lung studies will look at whether the addition of Vargatef (BIBF 1120) to standard second-line treatment regimes will improve the outcome for these patients, and with 2,600 patients, is one of the largest clinical trial programmes in this indication. There remains a great need for new treatments for cancer patients to prevent suffering and prolong life," he added. Vargatef (BIBF 1120), works by simultaneously inhibiting vascular endothelial growth factor receptors (VEGFRs), platelet-derived growth factor receptors (PDGFRs) and fibroblast growth factor receptors (FGFRs)1 - all crucially involved in the formation of blood vessels and is administered as a capsule taken twice daily. As angiogenesis plays a pivotal role in the growth of all solid tumours, Vargatef (BIBF 1120) is currently being investigated in a number of indications including advanced NSCLC, prostate cancer, ovarian cancer and colorectal cancer. The decision to progress this molecule into phase-III trials in NSCLC was based on phase-I and II results which showed the agent to be both efficacious and well tolerated when administered as both monotherapy and in combination.

In a phase-II Vargatef (BIBF 1120) study2, which included 74 patients with relapsed, advanced NSCLC, notable results were reported for patients with good performance status (ECOG 0 or 1) (n=57): these patients experienced longer overall survival (OS) (median OS was 9.5 months), longer progression free survival (PFS) (median PFS was 2.9 months) and a higher rate of disease control (59%) compared to the overall study population. Stable disease rate was 48 per cent. The majority of adverse events reported in the study were mild to moderate in nature. In phase-I studies, Vargatef (BIBF 1120) was observed to be well tolerated at a dose of 200mg twice daily when given in combination with pemetrexed3 or aclitaxel/carboplatin4 in NSCLC patients and when given in combination with docetaxel in hormone refractory prostate cancer patients. In addition, initial signs of clinical efficacy were observed.

According to Dr Manfred Haehl, corporate senior vice president medicine, Boehringer Ingelheim, the latest developments across the company's oncology portfolio are testament to its continued commitment to research and development in oncology and indicative of the continual progress being made. "The commencement of our second pivotal phase-III trial programme within the oncology portfolio, a potential first-in-class within our cell cycle kinase family and an additional phase-III trial planned for Tovok (BIBW 2992) reinforce the fact. Eastern Cooperative Oncology Group (ECOG) performance status are scales and criteria used by doctors and researchers to assess how a patient's disease is progressing, assess how the disease affects the daily living activities of the patient, and determine appropriate treatment and prognosis. Seite 3 that our pipeline continues to move closer to our goal - to develop innovative treatment options that we hope will ultimately offer patients with cancer better treatment options," said Dr Haehl.