On April 14, 2016 Puma Biotechnology, Inc. (NYSE: PBYI), a biopharmaceutical company, reported that results from the NEfERT-T Phase II clinical trial of neratinib in ERBB2-positive metastatic breast cancer patients were published online in JAMA Oncology (Press release, Puma Biotechnology, APR 14, 2016, View Source [SID:1234510802]). The article, entitled "Neratinib Plus Paclitaxel vs. Trastuzumab Plus Paclitaxel in Previously Untreated Metastatic ERBB2-Positive Breast Cancer: The NEfERT-T Randomized Clinical Trial," appears in the April 14, 2016 online issue and will be published in a future print issue of the journal. Schedule your 30 min Free 1stOncology Demo! The NEfERT-T trial is 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 trial enrolled 479 patients in 33 countries who had not received prior anticancer therapy for locally recurrent or metastatic disease. Patients were randomized to receive first-line treatment with either paclitaxel plus neratinib or paclitaxel plus trastuzumab. The primary endpoint of the trial was progression-free survival (PFS). The secondary endpoints of the study included objective response rate (ORR) and the incidence of central nervous system (CNS) metastases, including brain metastases.
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The results of the trial demonstrated that the progression-free survival for the patients who received the combination of paclitaxel plus neratinib was 12.9 months and the progression-free survival for the patients who received the combination of paclitaxel plus trastuzumab was 12.9 months (hazard ratio 1.02, p=0.89). The objective response rate in the trial for the patients who received the combination of paclitaxel plus neratinib was 74.8% and the objective response rate for the patients who received the combination of paclitaxel plus trastuzumab was 77.6% (p=0.52).
With respect to the incidence of CNS metastases (e.g., brain metastases), treatment with the combination of paclitaxel plus neratinib resulted in a 52% reduction in the incidence of CNS metastases compared to the incidence of CNS metastases in patients who received the combination of paclitaxel plus trastuzumab. Symptomatic or progressive CNS recurrences occurred in 20 patients (8.3%) in the neratinib-paclitaxel group and 41 patients (17.3%) in the trastuzumab-paclitaxel group (relative risk 0.48, p=0.002). The estimated Kaplan-Meier 2-year incidence of CNS recurrences was 16.3% in the neratinib-paclitaxel group and 31.2% in the trastuzumab-paclitaxel group (hazard ratio 0.45, p=0.004). These results reflect a statistically significant difference between the two treatment arms.
"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," said Alan H. Auerbach, Chief Executive Officer and President. "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."