Corporate News Blog - Puma Biotechnology’s 5-Year Analysis of Phase-III ExteNET Study Gets Published in ‘The Lancet Oncology’
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LONDON, UK / ACCESSWIRE / November 16, 2017 / Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for Puma Biotechnology, Inc. (NASDAQ: PBYI), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/?symbol=PBYI. The biopharmaceutical Company, which focuses on the development and commercialization of innovative products to enhance cancer care, announced on November 13, 2017, that its previously presented results from the ExteNET Phase-III clinical trial for Neratinib in patients with early stage HER2-positive breast cancer got published in the online journal ‘The Lancet Oncology'. For immediate access to our complimentary reports, including today's coverage, register for free now at:
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The article is titled: "Neratinib after trastuzumab-based adjuvant therapy in early stage HER2-positive breast cancer (ExteNET): 5-year analysis of a randomized, double blind, placebo-controlled phase III trial". It appeared in the November 13th online issue of ‘The Lancet Oncology' and will be published in the print issue of the journal in the near future.
HER2-Positive Breast Cancer, Worst of All Breast Cancers
HER2-positive breast cancer is among the most aggressive forms of breast cancer. Nearly 20% to 25% of breast cancer tumors over-express the HER2 protein, and this could have life debilitating outcomes.
Research suggests that trastuzumab can reduce the risk of early stage HER2-positive breast cancer returning after surgery. However, around 25% of the patients treated with trastuzumab did experience a recurrence.
About Neratinib
NERLYNX (or Neratinib) is a kinase inhibitor indicated for the treatment of adult patients with early-stage HER2 amplified breast cancer, following the adjuvant trastuzumab-based therapy. NERLYNX tablets are meant for oral use.
The US Food and Drug Administration (FDA) approved Neratinib in July 2017 for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy. Currently, it is being marketed in the United States as NERLYNX (Neratinib) tablets.
About the ExteNET Trial
The ExteNET trial is the Phase-III trial of Neratinib. It is a double blind, placebo-controlled trial of Neratinib versus placebo after adjuvant treatment with trastuzumab in patients with early stage HER2-positive breast cancer.
The online publication in ‘The Lancet Oncology' covered the pre-defined 5-year invasive disease free survival (iDFS) analysis, which is a follow-up to the primary 2-year iDFS analysis of the Phase-III ExteNET trial.
The trial randomized 2,840 patients in 41 countries with early stage HER2-positive breast cancer who had undergone surgery and adjuvant treatment with trastuzumab.
Once the adjuvant treatment with trastuzumab was completed, the patients were randomized to receive extended adjuvant treatment with either Neratinib or placebo for one year.
Post that, patients were tracked for invasive recurrent disease, ductal carcinoma in situ (DCIS), or death for a period of five years.
Study Checkpoints and Results
Primary Endpoint
The primary endpoint was invasive disease free survival (iDFS). The trial revealed that after a median follow up of 5.2 years, treatment with Neratinib led to a 27% reduction in the risk of invasive disease recurrence or death versus placebo (hazard ratio = 0.73, p = 0.008). The 5-year iDFS rate for the Neratinib arm was 90.2% compared to 87.7% for the placebo arm.
Secondary Endpoint
The secondary endpoint of the trial was invasive disease free survival including ductal carcinoma in situ (iDFS-DCIS). The results indicated that the treatment with Neratinib reduced the risk of disease recurrence including DCIS or death by 29% versus placebo (hazard ratio = 0.71, p = 0.004). The 5-year iDFS-DCIS rate for the Neratinib arm was 89.7% compared to 86.8% for the placebo arm.
Other Findings
For the pre-defined subgroup of patients with hormone receptor positive disease, the results confirmed that treatment with Neratinib led to a reduction of 40% in the risk of invasive disease recurrence or death versus placebo (hazard ratio = 0.60, p = 0.002). The 5-year iDFS rate for the Neratinib arm was 91.2% compared to 86.8% for the placebo arm.
On the other hand, for the pre-defined subgroup of patients with hormone receptor negative disease, the results of the trial revealed that the treatment with Neratinib resulted in a hazard ratio of 0.95 (p = 0.762).
Safety Results Unchanged From the Primary 2-year iDFS Analysis
The safety results remain unchanged from the primary 2-year iDFS analysis of the study, which disclosed that the most common adverse event for Neratinib-treated patients was diarrhea, with nearly 39.9% of the Neratinib-treated patients experiencing grade 3, or higher, diarrhea (1 patient (0.1%) had grade 4 diarrhea).
In this trial, patients who were given Neratinib were not given any prophylaxis with antidiarrheal agents to prevent the Neratinib-related diarrhea.
Puma Biotechnology is conducting the CONTROL trial to evaluate the use of Loperamide based prophylaxis to reduce the incidence of grade 3, or higher, diarrhea in patients with early stage HER2-positive breast cancer who have completed adjuvant trastuzumab-based treatment.
The latest data reported from the CONTROL trial was in June 2017. It showed that the use of Loperamide-based prophylaxis reduced the rate of grade 3 diarrhea with Neratinib, wherein the rates of grade 3 diarrhea ranged between 8% - 31% when Loperamide-based prophylaxis was used.
Remarks from Puma Biotechnology's CEO
Alan H. Auerbach, President and Chief Executive Officer (CEO) of Puma Biotechnology, expressed his pleasure on the fact that ‘The Lancet Oncology' journal chose to publish ExteNET results. He mentioned that ExteNET is the first trial with a HER2-targeted agent that has demonstrated a benefit in the extended adjuvant setting. This, he believes, would be an important differentiating factor for Neratinib in the treatment of HER2-positive breast cancer.
Last Close Stock Review
On Wednesday, November 15, 2017, the stock closed the trading session at $100.70, marginally climbing 0.50% from its previous closing price of $100.20. A total volume of 1.29 million shares have exchanged hands, which was higher than the 3-month average volume of 805.14 thousand shares. Puma Biotechnology's stock price soared 24.78% in the last three months, 161.56% in the past six months, and 133.91% in the previous twelve months. Furthermore, since the start of the year, shares of the Company have skyrocketed 228.01%. At Wednesday's closing price, the stock's net capitalization stands at $4.63 billion.
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