Boeh Ing to start Ph III BIBW 2992 study

German, privately-owned drug maker Boehringer Ingelheim says that it intends to conduct a pivotal Phase III trial of its developmental anticancer agent BIBW 2992 in lung cancer. The firm added that plans for the study, which were announced at the 12th World Conference on Lung Cancer in Seoul, South Korea, are currently being finalized with both the European Medicines Agency (EMEA) and the US Food and Drug Administration.

Boehringer said that, in previous trials of the drug in patients with various types of solid tumors, encouraging results were obtained in non-small cell lung cancer, particularly in forms of the disease associated with mutant versions of the epidermal growth factor receptor encoding gene. Specifically, durable partial responses were observed in 20% of those treated with at least two responders having deletions in EGFR exon 19, a mutation strongly linked to the disease. The agent also demonstrated good tolerability at daily doses of up to 50mg.

Current Phase II studies of BIBW 2992 indicate that it has activity against tumors resistant to first generation EGFR and HER2 inhibitors, probably as a result of its ability to affect both targets. The firm said that, because the drug has demonstrated considerable efficacy in cancers associated with specific mutations, it has great potential as a patient-targeted specific treatment.