Puma reports Phase II data for neratinib in HER2-positive breast cancer with brain metastases

In an abstract released ahead of the American Society of Clinical Oncology meeting in Chicago, Puma Biotechnology Inc. (NASDAQ:PBYI) reported data from 37 evaluable HER2-positive breast cancer patients with progressive brain metastases 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 ≥50% reduction in volumetric sum of target CNS lesions in 49% of patients. The 12-month overall survival (OS) rate was 63%.

The open-label, U.S. trial is evaluating the primary endpoint of a composite CNS objective response rate (ORR) requiring a ≥50% reduction in volumetric sum of target CNS lesions (volumetric ORR), no progression of non-target or non-CNS lesions, no new lesions, no escalating steroid use and no progressive neurologic symptoms. Secondary endpoints include progression-free survival (PFS), OS, CNS response by Macdonald criteria, first site of disease progression, safety, and association of circulating tumor cell (CTC) count and OS. The trial was sponsored by the Dana-Farber Cancer Institute. Puma previously reported data from the trial (see BioCentury, June 9, 2014)...