PBYI - Puma Bio's neratinib meaningful reduces risk of recurrence and improves survial in early stage breast cancer patients

Puma Biotechnology (PBYI) jumps 9% after-hours after presenting efficacy results of neratinib in HER2-positive early stage breast cancer (eBC) from the Phase III ExteNET trial at the 2020 Virtual San Antonio Breast Cancer Symposium. The trial included 2,840 patients who received neratinib after neoadjuvant and/or adjuvant therapy with chemotherapy and trastuzumab. The primary endpoint was invasive disease-free survival (iDFS). Secondary endpoints include overall survival and cumulative incidence of CNS metastases. In the ITT population, 127 of 1420 patients (8.9%) in the neratinib group and 137 of 1420 patients (9.6%) in the placebo group died, as of the analysis cut-off date (July 2019).The estimated 8-year overall survival ((OS)) rates were 90.1% in the neratinib group and 90.2% in the placebo group (stratified HR 0.95; 95% confidence interval [CI] 0.75-1.21; p=0.69).The cumulative incidence of CNS metastases at 5 years was 1.3% (95% CI 0.8-2.1) in the neratinib arm and 1.8% (95% CI 1.2-2.7%) in

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Puma Bio's neratinib meaningful reduces risk of recurrence and improves survial in early stage breast cancer patients