Oral neratinib: Phase II data
Top-line data from the open-label, international Phase II NEfERTT trial in 479 patients with previously untreated HER2-positive locally recurrent or metastatic breast cancer showed that once-daily 240 mg oral neratinib plus paclitaxel missed the primary endpoint of improving PFS vs. Herceptin trastuzumab plus paclitaxel (16.6 vs. 16.7 months, p=0.35). Neratinib plus paclitaxel also missed the secondary endpoint of improving ORR vs. Herceptin plus paclitaxel (74.8% vs. 75.1%, p=0.94). Neratinib plus paclitaxel did meet the secondary endpoint of reducing the incidence of CNS metastases vs. Herceptin plus paclitaxel (7.4% vs. 15.6%, p=0.006). The most common adverse event reported in patients receiving neratinib plus paclitaxel was diarrhea. Grade 3 diarrhea occurred in about 30% of patients receiving neratinib plus paclitaxel vs. about 4% for Herceptin plus paclitaxel. Puma said patients in NEfERTT did not receive any prophylaxis with antidiarrheal agents to prevent the neratinib-related diarrhea. All patients in the company's current ongoing trials of neratinib are receiving prophylactic treatment with high doses of the antidiarrheal agent loperamide. ...