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Wyeth Announces Positive Data from Phase 2 Study of Neratinib in Advanced HER-2-Positive Breast Cancer
Date:12/12/2008

- Global Phase 3 Program Expected to Begin in December -

COLLEGEVILLE, Pa., Dec. 12/PRNewswire-FirstCall/ --Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), today announced data from an open-label phase 2 clinical trial of neratinib (HKI-272) in women with advanced HER-2-positive breast cancer. These data suggest that neratinib has antitumor activity in patients with advanced breast cancer positive for the ErbB-2 receptor (also known as HER-2 or Neu). These data were presented today during an oral session at the CTRC-AACR San Antonio Breast Cancer Symposium.

Neratinib is an investigational orally-administered potent and irreversible dual inhibitor of the HER-2 and EGFR kinases. Wyeth expects to initiate the first study in a global phase 3 program for neratinib in advanced HER-2-positive breast cancer later this month.

"Neratinib demonstrated activity against trastuzumab-resistant and trastuzumab-naive HER-2-positive breast cancer," said Harold Burstein, M.D., Ph.D., a study lead investigator at Dana-Farber Cancer Institute in Boston. "These results warrant ongoing study to see whether neratinib will fit into our armamentarium of anti-HER2 drugs."

The phase 2 study evaluated the safety and efficacy of a daily 240 mg oral dose of neratinib in 136 women diagnosed with ErbB-2-positive locally advanced or metastatic breast cancer (stage IIIB, IIIC or IV). The primary end point of the open-label, two-arm study was the 16-week progression-free survival (PFS) rate. Secondary end points included safety, objective response rate (complete and partial responses) and clinical benefit rate (objective response plus stable disease).

Patients were assigned to one of two study arms based on prior treatment with trastuzumab (Herceptin(R), Gene
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SOURCE Wyeth Pharmaceuticals
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