Oral neratinib: Phase II data

Data from 14 patients with stage IIIB or stage IV NSCLC with documented somatic HER2 mutations in the combination arm of an open-label, U.S. and French Phase II trial showed that once-daily 240 mg oral neratinib plus once-weekly 8 mg IV Torisel temsirolimus led to an ORR of 21%, including 3 partial responses. There were 11 cases of stable disease and 9 patients achieved clinical benefit, defined as partial response or stable disease for =12 weeks. Data from 13 patients with stage IIIB or stage IV NSCLC with documented somatic HER2 mutations in the monotherapy arm showed that once-daily 240 mg oral neratinib led to an ORR of 0%. There were 7 cases of stable disease and 4 patients achieved clinical benefit. Median PFS was 2.9 months in the monotherapy arm and 4 months in the combination arm. ...