PBYI - Puma Biotech's neratinib shows improved CNS outcomes in late-stage breast cancer study

Puma Biotechnology ([[PBYI]] +4.0%) results from its Phase 3 NALA trial show improved central nervous system ((CNS)) outcomes with neratinib-based regimens in the treatment and prevention of CNS metastases from HER2-positive breast cancer.Trial was a randomized controlled trial of neratinib plus capecitabine versus Tykerbplus capecitabine in patients with third-line HER2-positive metastatic breast cancer.The study met its primary endpoint, with the neratinib arm having significantly improved progression free survival ((PFS)) vs lapatinib arm (mean PFS 8.8 months vs. 6.6). Data showed no statistical difference in OS between treatment arms.In intent-to-treat population, significantly fewer interventions for CNS disease occurred neratinib vs. lapatinib (cumulative incidence, 22.8% vs. 29.2%).Also data analysis of subset of 101 patients with asymptomatic CNS metastases at baseline showed, mean PFS was 7.8 months in the neratinb arm vs. 5.5 months in the laptinib arm, with cumulative incidence of 25.5% vs. 36%.

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Puma Biotech's neratinib shows improved CNS outcomes in late-stage breast cancer study