Puma Biotechnology, Inc. PBYI announced interim results from the ongoing phase II study on PB272 (neratinib) for the treatment of patients with ERBB2 mutant, human epidermal growth factor receptor type 2 (HER2) non-amplified, metastatic breast cancer.
Data were presented at the 2015 Cancer Therapy & Research Center – the American Association for Cancer Research (CTRC-AACR) San Antonio Breast Cancer Symposium.
Efficacy results revealed that 6 out of 19 patients experienced a response at week 8, which included 1 patient with a complete response and 5 with partial responses. In addition, data revealed that three patients had a confirmed objective response, while eight demonstrated clinical benefit. The median progression-free survival for 8 patients was observed at four months.
The multicenter, open-label, multi-histology study is evaluating PB272 in patients with metastatic breast cancer, whose tumors have a HER2 mutation but are neither HER2 amplified nor overexpressed (HER2 negative).
PB272 is also being evaluated in combination with AstraZeneca plc’s AZN Faslodex (fulvestrant) for the treatment of postmenopausal hormone receptor positive breast cancer patients. The company plans to initiate pivotal studies on this combination in 2016.
In addition, the company presented data from the phase II FB-7 study on the candidate for neoadjuvant treatment of locally advanced HER2-positive breast cancer.
The randomized study evaluated PB272 as a monotherapy and in combination with Roche Holding AG’s RHHBY Herceptin (trastuzumab) in women with HER2-positive locally advanced stage IIB-IIIC invasive breast cancer.
Puma Biotechnology currently carries a Zacks Rank #4 (Sell). A better-ranked stock in the health care sector is Achillion Pharmaceuticals, Inc. ACHN with a Zacks Rank #1 (Strong Buy).
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