Puma Biotechnology has found positive results from the NEfERT-T phase II clinical trial of neratinib in ERBB2-positive metastatic breast cancer patients.

The NEfERT-T trial is a randomised, 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 locally recurrent or metastatic breast cancer.

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The trial enrolled 479 patients from 33 countries, who had not received prior anticancer therapy for locally recurrent or metastatic disease.

During the trial, patients were randomised to receive first-line treatment with either paclitaxel plus neratinib or paclitaxel plus trastuzumab.

"We believe this provides a meaningful point of differentiation for neratinib in the treatment of HER2-positive breast cancer."

The trial’s primary endpoint was progression-free survival (PFS), while, 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 trial results showed that progression-free survival for patients who received the combination of paclitaxel plus neratinib was 12.9 months, and progression-free survival for patients who received the combination of paclitaxel plus trastuzumab was 12.9 months (hazard ratio 1.02, p=0.89).

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The trial’s objective response rate for patients who received the combination of paclitaxel plus neratinib was 74.8%, while the objective response rate for patients who received the combination of paclitaxel plus trastuzumab was 77.6% (p=0.52).

With respect to the incidence of CNS metastases, for instance brain metastases, treatment with the combination of paclitaxel plus neratinib resulted in a 52% reduction in the incidence of CNS metastases compared with 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 two-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), resulting a statistically significant difference between the two treatment arms.

Puma Biotechnology chief executive officer and president Alan Auerbach said: "The NEfERT-T trial represents the first randomised trial with a HER2-targeted agent that has shown a statistically significant reduction in the incidence of CNS metastases.

"We believe this provides a meaningful point of differentiation for neratinib in the treatment of HER2-positive breast cancer."