Wyeth Announces Positive Data from Phase 2 Study of Neratinib in Advanced HER-2-Positive Bre...(ntech) the standard of care for the trea...),Health

Date:12/12/2008

ntech), the standard of care for the treatment of advanced ErbB-2-positive breast cancer. Women enrolled in arm A (n=66) had either previously received at least six weeks of standard trastuzumab treatment or had experienced disease progression during or following trastuzumab-containing adjuvant therapy. Women in arm B (n=70) received no prior treatment with any ErbB-2-targeted therapy, including trastuzumab.

The efficacy analysis included 127 evaluable patients, 61 in arm A and 66 in arm B. In patients who were previously treated with trastuzumab (arm A), the 16-week PFS rate was 60 percent, and the median PFS was 23 weeks, as evaluated by independent assessment. The objective response rate was 26 percent, and the clinical benefit rate was 36 percent. In patients who had not received trastuzumab treatment (arm B), the 16-week PFS rate was 77 percent, and the median PFS was 40 weeks by independent assessment. The objective response rate was 56 percent, and the clinical benefit rate was 68 percent.

Adverse events of any grade occurring in more than 15 percent of study patients included diarrhea, nausea, vomiting, fatigue, anorexia, abdominal pain, headache and rash. Diarrhea was the most common toxicity and was observed in 93 percent of patients. Diarrhea was also the most significant grade 3 or 4 adverse event, occurring in 21 percent of patients. Diarrhea was reversible and generally manageable by medication, treatment interruption or dose reduction. One patient discontinued treatment due to diarrhea.

"Wyeth's exploration of neratinib demonstrates our ongoing commitment to research of promising investigational therapies in areas of significant unmet medical need, including oncology and women's health," says Gary L. Stiles, M.D., Chief Medical Officer, Wyeth. "These phase 2 data provide important insight into the potential clinical utility of neratinib in HER2-positive breast ca
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SOURCE Wyeth Pharmaceuticals Copyright©2008 PR Newswire. All rights reserved

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