Puma Biotechnology Inc. (NASDAQ: PBYI) shares made a handy gain early on Thursday after the company presented updated results from its Phase 2 Summit clinical trial of neratinib at the 2019 San Antonio Breast Cancer Symposium (SABCS).
Neratinib was approved by the U.S. Food and Drug Administration (FDA) in July 2017 for the extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy and is marketed in the United States.
Overall, the study has so far demonstrated encouraging clinical activity with durable responses in this heavily pretreated metastatic breast cancer patient population. By the looks of it, management will continue enrollment in this cohort of the study.
The interim efficacy summary of the breast cohort that received neratinib in combination with trastuzumab and fulvestrant showed that for the 17 efficacy evaluable patients, nine patients (53%) experienced a confirmed objective response, all of which were classified as partial responses, and 10 patients (59%) experienced clinical benefit.
Alan H. Auerbach, CEO and president of Puma Biotech, commented:
We are very pleased with the activity seen with neratinib in combination with trastuzumab and fulvestrant in this cohort of patients with HER2-mutated breast cancer. We are in the process of expanding this HR-positive breast cancer cohort in SUMMIT with the intent of using this data to support future registration. We look forward to enrolling additional patients into this HR-positive breast cancer cohort in order to generate the additional data required to support approval of this combination therapy.
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Shares of Puma Biotech closed Wednesday at $8.69, in a 52-week range of $6.26 to $43.90. The consensus price target is $12.13. Following the announcement, the stock was up over 3% in early trading indications Thursday.
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