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

• Puma Biotech (NASDAQ: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 for HER2+ metastatic breast cancer.
• https://seekingalpha.com/news/3619964-puma-bios-neratinib-shows-incremental-survival-benefit-in-late-stage-breast-cancer-study