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ARTICLE | Clinical News

Puma reports additional Phase II data for neratinib in breast cancer with brain metastases

June 9, 2017 7:54 PM UTC

Puma Biotechnology Inc. (NASDAQ:PBYI) reported additional data from 37 evaluable HER2-positive breast cancer patients with progressive brain metastases and no prior lapatinib treatment in the third cohort of the Phase II TBCRC 022 trial showing that once-daily 240 mg oral neratinib (HKI-272, PB272) plus capecitabine led to a CNS response rate by Response Assessment in Neuro-Oncology-Brain Metastases (RANO-BM) criteria, a secondary endpoint, of 24%. Median time to CNS progression was 5.5 months and median overall survival (OS) was 13.5 months. The updated estimated 12-month OS rate was 57%. Data were presented at the American Society of Clinical Oncology meeting in Chicago.

In an abstract released ahead of the meeting, Puma reported that neratinib plus capecitabine led to a ≥50% reduction in volumetric sum of target CNS lesions in 49% of patients (see BioCentury, June 5)...