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Neratinib extends 5-year invasive DFS in HER-2–positive breast cancer

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Neratinib extended 5-year invasive DFS compared with placebo among women with HER-2–positive early-stage breast cancer, according to interim results of the ExteNET trial released by the drug’s manufacturer.

The double blind, placebo-controlled phase 3 trial included 2,840 women with early-stage HER-2–positive breast cancer who underwent surgery and adjuvant treatment with trastuzumab (Herceptin, Genentech).

Researchers randomly assigned patients to extended adjuvant treatment with neratinib (PB272, Puma Biotechnology) or placebo for 1 year. Invasive DFS served as the primary endpoint.

Previously reported results showed neratinib treatment resulted in a 33% reduction of risk for invasive disease recurrence or death (HR = 0.67; P = .009) and also improved the 2-year DFS rate (93.9% vs. 91.6%).

An analysis that included updated 3-year and 4-year invasive DFS, as well as 5-year interim DFS, was performed to help support the new drug application filing in the United States and the marketing authorization application submission in Europe.

Researchers reported higher rates of 5-year interim DFS with neratinib among the intent-to-treat population (90.4% vs. 87.9%), as well as among a predefined subset of 1,631 patients with hormone receptor–positive disease (91.7% vs. 86.9%). The results showed neratinib resulted in a 26% reduction in risk for invasive disease recurrence or death (HR = 0.74; P = .017).

Results showed neratinib improved the rates of 3-year DFS in the intent-to-treat population (92.5% vs. 90.3%) and those with hormone receptor–positive disease (93.8% vs. 89.9%). The drug also improved 4-year DFS in the intent-to-treat population (91.4% vs. 89.2%) and those with HR-positive disease (92.9% vs. 88.6%).

“We are very pleased with the interim 5-year invasive DFS results from the ExteNET trial with neratinib,” Alan H. Auerbach, CEO and president of Puma, said in the press release. “We believe these results support the long-term clinical benefit of neratinib in the extended adjuvant treatment of patients with early stage HER-2–positive breast cancer who have completed prior trastuzumab-based adjuvant therapy. We look forward to obtaining the full 5-year DFS data, which we anticipate will be available in 2017.”