Puma Biotechnology Says Online JAMA Oncology Publishes Its NEfERT-T Stage 2 Trial

Puma Biotechnology Inc PBYI disclosed the results of its NEfERT-T Phase two clinical study were published online in JAMA Oncology. The result was in respect of neratinib in ERBB2-positive metastatic breast cancer patients. The company indicated the article was titled as "Neratinib Plus Paclitaxel vs. Trastuzumab Plus Paclitaxel in Previously Untreated Metastatic ERBB2-Positive Breast Cancer: The NEfERT-T Randomized Clinical Trial."

Puma Biotechnology said the article appeared on April 14 online issue and that it would be published in a future print issue of the journal. The medical firm said The NEfERT-T trial was a randomized, two-arm Phase II trial of neratinib plus the anticancer drug paclitaxel versus trastuzumab (Herceptin) plus paclitaxel as a first-line treatment for ERBB2-positive (previously referred to as HER2-positive) locally recurrent or metastatic breast cancer.

The company disclosed the trial enrolled 479 patients from 33 countries who have not received prior anticancer therapy for locally recurrent or metastatic disease. The biotech firm said the patients were randomized to get first-line treatment with either paclitaxel plus neratinib or paclitaxel plus trastuzumab.

Puma Biotechnology said the primary endpoint of the study was progression-free survival (PFS) while the secondary endpoints of the trial included objective response rate (ORR) and the incidence of central nervous system (CNS) metastases. That included brain metastases.

The company's CEO and President, Alan Auebach, said "The NEfERT-T trial represents the first randomized trial with a HER2-targeted agent that has shown a statistically significant reduction in the incidence of CNS metastases." He added that "We believe this provides a meaningful point of differentiation for neratinib in the treatment of HER2-positive breast cancer. We are pleased that JAMA Oncology has chosen to publish these results."

On Thursday, Puma Biotechnology shares traded up by 1.29 percent.