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DxS Hopes AstraZeneca's Iressa EU Launch Will Help Build Companion Test Business

This article was originally published in The Pink Sheet Daily

Executive Summary

U.K. firm views collaboration with AstraZeneca as a baby step to gaining a foothold in the yet-unformed European companion diagnostics market.

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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)

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)

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