Wyeth's neratinib shows 45% 16-week PFS in HER2 patients

US drug major Wyeth reported strong preliminary data from an ongoing Ph I/II study of neratinib plus Roche's Herceptin (trastuzumab) in patients  with advanced ErbB-2 positive breast cancer that progressed following  therapy with Herceptin, the standard-of-care in this disease setting.

The primary endpoint of the two-part study is 16-week progression-free  survival, which so far is 45%. Median PFS was 16 weeks. The complete  response rate was 7%, while 21% of evaluable patients showed partial  response. The objective response rate was 29%.

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