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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

COLLEGEVILLE, Pa., May 29 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), today announced preliminary data from two ongoing studies, one evaluating neratinib (HKI-272) in combination with trastuzumab (Herceptin(R), Roche) in HER-2 positive (ErbB-2 positive) breast cancer, and a separate study investigating neratinib safety and efficacy when given with paclitaxel (Taxol(R), Bristol-Myers Squibb) in patients with HER-2 dependent solid tumors. The data gathered from both trials are scheduled to be presented at the 45th Annual Meeting of the American Society of Clinical Oncology Annual Meeting in Orlando, Florida, from May 29 to June 2, 2009. Neratinib is an investigational orally administered irreversible inhibitor of the HER-2 and EGFR kinases.

"The data gathered from these studies provide additional evidence suggesting that neratinib, when combined with these therapies, is an active agent in HER-2 positive breast cancer," says Ramona Swaby, M.D., Department of Medical Oncology, Fox Chase Cancer Center, Philadelphia, PA. "While improvements have been made in treating HER-2 positive breast cancer, there remains an unmet medical need for more therapies for patients with metastatic breast cancer. These data warrant ongoing and future investigations to further understand and evaluate the utility of neratinib against this aggressive disease."

Neratinib (HKI-272) in Combination with Trastuzumab for the Treatment of Advanced Breast Cancer

This ongoing phase 1/2 study of neratinib in combination with trastuzumab evaluated patients with advanced ErbB-2 positive breast cancer that progressed following therapy with trastuzumab, the standard of care in this disease setting. The primary endpoint of the two-part study is 16-week progression-free survival (PFS). The first part of
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SOURCE Wyeth Pharmaceuticals
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