R&D In Brief

Boehringer starts Phase III for lung cancer drug: Boehringer Ingelheim initiates a third Phase III trial for its non-small cell lung cancer drug BIBW 2992 (proposed trade name Tovok), now as first-line treatment in NSCLC patients with epidermal growth factor receptor mutations, the firm announced Aug. 3 at the International Association for the Study of Lung Cancer conference in San Francisco. The LUX-Lung 3 trial will compare single-agent BIBW 2992 to standard chemotherapy (cisplatin/pemetrexed). It is the first orally-administered irreversible dual inhibitor of EGFR and HER2 to reach Phase III development in NSCLC. The firm presented new preliminary Phase II data at the conference showing a response rate of 63 percent and a disease control rate of 97 percent in 38 evaluable first-line NSCLC patients with an EGFR mutation; most commonly observed adverse events were Grade 3 and included diarrhea, skin-related adverse events and mouth ulcerations. Boehringer announced in May an agreement with the Manchester, UK-based company DxS to provide a companion diagnostic test kit for BIBW 2992 to identify mutations of the EGFR in NSCLC patients. AstraZeneca is also working with DxS to target patients with EGFR mutations as a way to revive its lung cancer therapy Iressa (1"The Pink Sheet" DAILY, Aug. 3, 2009)