Shares of Puma Biotechnology, Inc. (NYSE: PBYI) 179.5% HIGHER; positive top line results from the Phase III clinical trial of Puma's investigational drug PB272 (neratinib) for the extended adjuvant treatment of breast cancer (ExteNET Trial). The ExteNET trial is a double-blind, placebo-controlled, Phase III trial of neratinib versus placebo after adjuvant treatment with trastuzumab (Herceptin) in women with early stage HER2-positive breast cancer. In addition to the statistically significant results, the company announced an amendment to its licensing agreement with Pfizer (NYSE: PFE) for PB272 (neratinib).
The drug, neratinib, improved disease-free survival by 33 percent compared with a placebo in a trial of 2,821 women with early-stage HER2-positive breast cancer, Los Angeles-based Puma said today in a statement. Disease-free survival refers to the interval a patient remains alive and free of signs of the illness. The company said it would apply for U.S. regulatory approval in the first half of 2015 based on the results.
If the drug is approved, neratinib may be used in many early-stage breast cancer patients whose tumors are fueled by a growth promoting gene called HER2. These patients are already often treated with the Roche Holding AG (ROG)’s Herceptin.
In the new trial, neratinib was used in women whose breast cancer had been removed surgically and then treated with Herceptin to prevent recurrence. After the Herceptin treatment was completed, some of the women got neratinib and some received a placebo.
7/23/14: the day following the announcement
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