BioCentury
ARTICLE | Clinical News

Oral neratinib: Interim Phase II data

January 5, 2015 8:00 AM UTC

Interim data from 37 patients with HER2-positive metastatic breast cancer in the first, MTD cohort of the Phase II portion of an international Phase I/II trial showed that once-daily 240 mg oral neratinib plus once-weekly 8 mg IV Torisel temsirolimus led to 11 partial responses. The median duration of response was 3 months and median PFS was 4.8 months. The Phase I portion of the trial identified once-daily 240 mg neratinib plus once-weekly 8 mg Torisel as the MTD. Patients in the second, dose-escalation cohort of the Phase II portion of the trial received once-daily 240 mg neratinib plus Torisel once weekly at an initial dose of 8 mg, which could be escalated up to 15 mg once weekly in patients who had no tolerability issues during the first cycle of treatment. Of 37 evaluable patients in dose-escalation cohort, there were 11 partial responses. The median duration of response was 7.4 months and median PFS was not yet mature. The most common adverse event reported was diarrhea. Patients in the MTD cohort received prophylactic treatment with low doses of the antidiarrheal agent loperamide and 12 patients in the cohort had grade 3 diarrhea. Patients in the dose-escalation cohort received high-dose loperamide and 7 patients had grade 3 diarrhea, 4 of whom were not compliant with the loperamide prophylaxis. Data were presented at the San Antonio Breast Cancer Symposium. ...