Puma (PBYI) Presents Favorable Phase II Data On Neratinib

Puma Biotechnology, Inc. (NYSE:PBYI) presented positive data from an investigator sponsored phase II study on neratinib in patients with HER2-mutated, non-amplified breast cancer. Data were presented at the annual meeting of the American Society of Clinical Oncology.

The primary endpoint of the study was the clinical benefit rate – defined as complete response (CR), partial response (PR) or stable disease (SD) greater than or equal to 6 months. While 14 patients had activating HER2 mutations, 2 patients had HER2 mutations of unknown significance among the 16 patients who were enrolled in the study.

Results showed that 5 patients achieved clinical benefit including 1 patient with a CR, 1 patient with a PR, and 3 patients with SD for greater than or equal to 6 months in the 14 patients with activating HER2 mutations. While the median duration of response in these 5 patients was 6 months, the median progression-free survival for all 14 patients was 5 months. No clinical benefit was observed with neratinib in the 2 patients who had HER2 mutations of unknown significance.

Moreover, the interim safety result showed that the most frequently observed adverse event was diarrhea.

We are encouraged by the phase II study results. Enrollment is currently underway in a cohort of patients receiving the combination of neratinib plus AstraZeneca’s plc (NYSE:AZN) Faslodex (fulvestrant). The company intends to present data from this cohort at a future medical meeting.

Meanwhile, Puma Biotech plans to seek approval for neratinib in the U.S. and EU in mid-2016 and in the second quarter of 2016, respectively. The company is looking to get neratinib approved for the extended adjuvant treatment of HER2-positive early stage breast cancer based on positive ExteNET phase III study results.

Given that Puma Biotech has no approved product in its portfolio at the moment and neratinib is its lead pipeline candidate, we expect investor focus to remain on updates pertaining to its development.

Puma Biotech is a Zacks Rank #3 (Hold) stock. A couple better-ranked stocks in the health care sector are ANI Pharmaceuticals, Inc. (NASDAQ:ANIP) and Retrophin, Inc. (NASDAQ:RTRX) , each sporting a Zacks Rank #1 (Strong Buy).