Puma (PBYI) Stock Up, Phase II Data On Neratinib Published

Puma Biotechnology, Inc. (NYSE:PBYI) announced that positive results from a randomized phase II study (I-SPY 2 – Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging And moLecular Analysis 2) on neratinib for the neoadjuvant treatment of breast cancer were published in the New England Journal of Medicine. The company’s shares were up 5.5% on the news.

The study, a collaborative effort among academic investigators, was conducted in women with newly diagnosed stage 2 or higher (tumor size at least 2.5 cm) breast cancer to evaluate whether adding investigational drugs to standard chemotherapy in the neoadjuvant setting is better than standard chemotherapy. The primary endpoint of the study was pathological complete response (pCR) in the breast and the lymph nodes at the time of surgery.

Results showed that treatment with the neratinib-containing regimen (neratinib plus paclitaxel followed by Adriamycin and Cytoxan) in HER2-positive patients (including those who were either hormone receptor-positive or negative) resulted in an estimated pCR rate of 39.4% compared with the control arm of 22.8%. On the safety front, the most frequently observed severe adverse event in the study was diarrhea.

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We are encouraged by the phase II study results. Per the company’s press release, the I-SPY 2 data represents the first clinical data on neratinib in the neoadjuvant treatment of breast cancer and recommends that the combination of paclitaxel plus neratinib holds potent activity for the treatment of HER2-positive breast cancer and a subset of patients with HER2-negative breast cancer.

Puma Biotech expects to report data from its ongoing studies on the candidate through 2016.

We remind investors that Puma Biotech had announced last month that it has submitted a regulatory application in the EU seeking approval for neratinib. The company is looking to get neratinib approved for the extended adjuvant treatment of HER2-positive early stage breast cancer that has previously been treated with Roche Holding (SIX:ROG) AG’s (OTC:RHHBY) Herceptin (trastuzumab)-based adjuvant therapy.

Meanwhile, Puma Biotech also plans to seek FDA approval for neratinib shortly.

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 #4 (Sell) stock. A couple of better-ranked stocks in the health care sector are Innoviva, Inc. (NASDAQ:INVA) and Pfizer Inc. (NYSE:PFE) . While Innoviva sports a Zacks Rank #1 (Strong Buy), Pfizer carries a Zacks Rank #2 (Buy).