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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

the study includes patients being administered neratinib (160 mg or 240 mg) daily plus weekly trastuzumab (4 mg/kg IV loading dose then 2 mg/kg). In the second part of the study, patients receive a weekly dose of trastuzumab with daily neratinib (240 mg).

To date, 45 patients have been enrolled and 28 patients were evaluable for efficacy. The 16-week PFS rate (for part 2) was 45 percent (95 percent CI, 26 percent to 62 percent); median PFS was 16 weeks (95 percent CI, 15 to 31 weeks). The complete response rate was 7 percent, while 21 percent of evaluable patients showed partial response. The objective response rate was 29 percent (95 percent CI, 13 percent to 49 percent).

In this study, adverse events of any grade were diarrhea, nausea, anorexia, vomiting, asthenia, rash and fatigue. In the 45 patients enrolled in this study, diarrhea was the most common adverse event, observed in 91 percent of patients, and was the most significant grade 3 or 4 adverse event, occurring in 16 percent of patients. Two patients receiving neratinib 240 mg reported adverse events leading to discontinuation of therapy.

Safety and Efficacy of Neratinib (HKI-272) in Combination with Paclitaxel in Patients with Solid Tumors

In a separate phase 1/2, open-label, 2-part study, ascending multiple daily oral doses of neratinib (160 mg, 240 mg) were administered in combination with IV paclitaxel 80 mg/m2, if tolerable, or 70 mg/m2 on days 1, 8 and 15. Patients with solid tumors (endometrial, cervical, colorectal and esophageal cancers) were entered in the phase 1 portion (part 1), and only patients with metastatic ErbB-2 positive breast cancer were enrolled in part 2. Safety and efficacy were investigated in patients with ErbB-2 positive metastatic breast cancer.

A total of 102 patients were enrolled in part 2 of the study and 97 patients were evaluable for efficacy. The overall
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SOURCE Wyeth Pharmaceuticals
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