Positive data in the early-stage extended adjuvant setting enhance neratinib’s clinical and commercial attractiveness.
By Zachary McLellan, Analyst
26 September 2016
I am an oncology analyst at Datamonitor Healthcare based in the New York office. I joined Datamonitor in June 2015 while...
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Phase III trial data have shown that neratinib (Puma Biotechnology) has promising efficacy in the early-stage human epidermal growth factor receptor 2-positive (HER2+) breast cancer extended adjuvant setting, which enhances the drug’s clinical and commercial potential. The final results from the ExteNET Phase III trial (ClinicalTrials.gov identifier: NCT00878709) showed that neratinib monotherapy given after adjuvant Herceptin (trastuzumab; Genentech/Roche/Chugai) treatment significantly improved the disease-free survival (DFS) rate of early-stage HER2+ breast cancer patients. Neratinib decreased the risk of invasive disease recurrence or death by 30% compared to placebo in the intent-to-treat (ITT) population and by 41% in the hormone receptor-positive (HR+) subgroup. At the five-year interim analysis, neratinib also increased DFS by 2.5% in the ITT group (90.4% versus 87.9%) and by 4.8% in the HR+ group (91.7% versus 86.9%) when compared to placebo.
The ExteNET trial data suggest neratinib can satisfy an unmet need in the treatment of early-stage HER2+ breast cancer, which enhances the drug’s clinical attractiveness. In recent years, the use of Herceptin in the adjuvant setting after surgical resection with or without radiotherapy has greatly reduced the HER2+ breast cancer disease recurrence rate. However, the unmet need for therapies that can further improve the recurrence rate has persisted. Approximately 25% of patients with HER2+ early-stage breast cancer still relapse after one year of adjuvant Herceptin-based treatment. Neratinib is the first targeted therapy to show it provides patients with a statistically significant clinical benefit in the extended adjuvant setting, which comprises patients who have received both surgery (with or without radiotherapy) and adjuvant Herceptin. Despite other ongoing trials testing the drug as a treatment for metastatic patients, Datamonitor Healthcare believes that neratinib’s clinical and commercial potential is highest in this setting.
Puma Biotechnology submitted a Marketing Authorization Application to the European Medicines Agency for neratinib in June 2016 and filed a New Drug Application with the US Food and Drug Association in July 2016. Both submissions are for the extended adjuvant setting and are based on the data from ExteNET. Based on these filings, approval in both regions is expected by Q2 2017.
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