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R&D In Brief

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

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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Pfizer halts Phase III axitinib trial: Pfizer announces the halt of Phase III axitinib trial in advanced pancreatic cancer patients late on Friday, Jan. 30. The press release was overshadowed by the news just days earlier of Pfizer's offer to merge with Wyeth (1"The Pink Sheet," Feb. 2, 2009, p. 8). The pancreatic trial evaluating axitinib - Pfizer's most advanced oncology candidate - was stopped after a data safety monitoring board found no evidence in interim results of improvement in the primary endpoint of survival in patients treated with axitinib and gemcitabine compared to gemcitabine alone (the current standard of care). Pfizer had predicted last summer that it would first file axitinib for pancreatic cancer (2"The Pink Sheet," June 23, 2008, p. 30); the firm is still committed to evaluating the VEGF receptor inhibitor in a Phase III second-line renal cell carcinoma trial and Phase II advanced non-small cell lung cancer and colorectal cancer studies

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