Dive Brief:
- Neratinib is a tyrosine kinase inhibitor that has been developed for treatment of women with early stage HER2-positive breast cancer.
- In phase III trials, neratinib increased disease-free survival in patients by 33% compared with a placebo.
- In October 2011, Puma licensed neratinib from Pfizer. Under the deal (which has since been amended), Pfizer provides clinical trial funding support and Puma pays Pfizer royalties. The amended agreement makes Puma responsible for more of the clinical trial expenses, while royalties are now fixed in the low-to-mid teens instead of the originally agreed-upon 10 to 20%.
Dive Insight:
Neratinib phase III trials included over 2800 women with early-stage HER2-positive breast cancer. The women had undergone surgery, as well as advanced treatment with Herceptin (trastuzumab). According to Puma CEO Alan Auerbach, this trial is the first with a HER2 targeted agent that has shown a statistically significant benefit in the extended adjuvant setting. He reiterated, however, that “there remains an unmet clinical need for further improvement in outcome in order to attempt to further reduce this risk of recurrence."
News of the trial's positive results led to a boom in Puma's stock price, which opened at $227 per share on Wednesday morning -- more than a 275% rise in its value.