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New Preliminary Data from Two Studies Show Clinical Activity of Neratinib in Combination with Trastuzumab and in Combination with Paclitaxel in Advanced HER-2 Positive Breast Cancer
Date:5/29/2009

response rate at 16-weeks (for part 2) was 63 percent (80 percent CI, 55.9 percent to 69.4).

In this preliminary analysis, the adverse event profile of the combination of neratinib (240 mg) plus paclitaxel (80 mg/m2) was similar to that reported with both agents as monotherapy. Adverse events of any grade were diarrhea, alopecia, infection, peripheral neuropathy, leucopenia, anemia, nausea, rash, fatigue and vomiting. The most common adverse event was diarrhea, observed in 89 percent of the 102 patients enrolled in part 2 and was the most significant grade 3 or 4 adverse event, occurring in 25 percent of patients. Fourteen patients had dose reductions and one patient withdrew from the study due to an adverse event.

"Emerging clinical data continue to suggest that neratinib, in combination with these therapies is tolerable and active in treating HER-2 positive disease, even in those women who have progressed while on other targeted therapies," says Gary L. Stiles, M.D., Chief Medical Officer, Wyeth Pharmaceuticals. "These additional data build upon results presented at the 2008 San Antonio Breast Cancer Symposium, and Wyeth is committed to evaluating further the potential of this investigational therapy."

In 2008, the American Cancer Society estimated that more than 182,000 women in the United States would be diagnosed with breast cancer, and more than 40,000 would die from the disease. The HER-2 receptor is over-expressed in 25 percent to 30 percent of patients with breast cancer.

About Wyeth

Wyeth is one of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing and marketing of pharmaceuticals, vaccines, biotechnology products, nutritionals and non-prescription medicines that improve the quality of life for people worldwide. The Company's major divisions include Wyet
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SOURCE Wyeth Pharmaceuticals
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