PBYI - Puma Bio's neratinib shows incremental survival benefit in late-stage breast cancer study

Puma Biotech (PBYI) is up 1% after hours after announcing results from a 2,840-subject Phase 3 clinical trial, ExteNET, evaluating Nerlynx (neratinib), after neoadjuvant and/or adjuvant therapy with chemotherapy and trastuzumab, in patients with HER2-positive early-stage breast cancer.The primary endpoint was invasive disease-free survival ((IDFS)). Overall survival was a secondary endpoint.Consistent with results announced in December 2018, the relative five-year IDFS benefit was over placebo was a modest 5.1% (90.8% vs. 85.7%) which dropped to 2.1% at year 8.In a subgroup of patients at high risk of recurrence, the five-year relative IDFS benefit was 7.4% which increased to 9.1% at year 8.On the safety front, the most common treatment-emergent adverse events (vs. placebo) were diarrhea (39% vs. 1% without mandatory anti-diarrheal prophylaxis), vomiting (4% vs. <1%) and fatigue (2% vs. <1%).The FDA OK'd Nerlynx in July 2017 as extended adjuvant therapy in early-stage HER2+ breast cancer and in February of this year

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Puma Bio's neratinib shows incremental survival benefit in late-stage breast cancer study