Boehringer Ingelheim’s bid to become a major player in oncology is moving closer to reality after the firm revealed that it will soon start late-stage trials of experimental lung cancer compound.

The German firm declared at the International Association for the Study of Lung Cancer congress in Seoul, South Korea, that it plans to commence Phase III trials in the disease with BIBW 2992, a novel kinase inhibitor that blocks the activity of both EGFR and HER2. Details of the trials are currently being finalised with the US Food and Drug Administration and the European Medicines Agency.

Boehringer presented data at the WCLC from a Phase I study evaluating the activity of BIBW 2992 and initial signs of clinical efficacy were observed, with durable partial responses seen in 20% of patients with non-small cell lung cancer with at least two of them having deletions in EGFR exon 19 - a genetic mutation known to be more common in females, never smokers and in patients with adenocarcinoma. In addition, BIBW 2992 was found to be well tolerated at an oral dose of 50mg daily.

Study investigator, James Spicer of Guy's Hospital, London, said that more effective treatments for lung cancer, with fewer side effects, are badly needed. He added that “novel, irreversible EGFR inhibitors like BIBW 2992 provide us with a glimpse of the next chapter in the evolution of lung cancer care, as they may bridge significant gaps in existing therapy, for example, addressing issues of resistance to treatment."

He went on to say that “not all lung cancer is the same, and an era of personalised prescribing in oncology is not far away”. In particular, patients most likely to benefit from drugs designed to hit EGFR and related targets are “female, light or never smokers, or those from East Asian populations, a group who often have adenocarcinoma tumours with mutated EGFR".

BIBF also shows promise

Boehringer also presented data from Phase I and II trials in advanced NSCLC patients who were treated with the triple angiokinase inhibitor BIBF 1120, which targets VEGF, FGF and PDGF receptors in several cells essential to blood vessel formation, making it more difficult for the tumour cells to recruit other kinases to build a blood supply.

The dose for BIBF 1120, in combination with pemetrexed or carboplatin/paclitaxel has been determined to be 200mg twice daily and the compound has been shown to be safe and well-tolerated. Encouraging signs of efficacy have been observed in the Phase II trial, the firm added, with a considerably high rate of disease stabilisation (48%) for all patients.

Andreas Barner, head of R&D at Boehringer, said “we are using advances and breakthrough science to actively develop targeted therapies - biologicals and small molecules - in areas of unmet medical need, with a particular interest in lung cancer".