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Puma Biotechnology (PBYI) Shares Soar On Breast Cancer Drug Results


7/23/2014 8:58:42 AM

Puma Biotechnology Shares Soar On Breast Cancer Drug Results
July 23, 2014
By Renee Morad, BioSpace.com Breaking News Staff

Shares of Puma Biotechnology Inc. (PBYI) more than tripled in after-hours trading Tuesday after the company reported positive clinical trial results of its experimental breast-cancer drug neratinib.

The phase III trial results revealed that neratinib, also known as PB272, improved disease-free survival for women with early stage, HER2-positive breast cancer by 33 percent compared with placebo after adjuvant treatment with Herceptin, also known as trastuzumab.

Along with the treatment of HER2-positive breast cancer, neratinib may also help patients with non-small cell lung cancer, breast cancer and other solid tumors that have the HER2 mutation, according to Puma Biotechnology, a Los Angeles-based development stage biopharmaceutical company.

The ExteNET trial studied 2,821 women in 41 countries with early stage, HER2-positive breast cancer. After surgery and completion of adjuvant treatment with Herceptin, patients were randomized to receive extended adjuvant treatment with either neratinib or placebo for a period of one year. Patients were then followed for recurrent disease, ductal carcinoma in situ (DCIS), or death during a period of two years. The primary endpoint of the trial was disease-free survival.
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“We are very pleased with the results of the ExteNET trial with neratinib,” said Alan H. Auerbach, president and chief executive officer for Puma. “This represents the first trial with a HER2 targeted agent that has shown a statistically significant benefit in the extended adjuvant setting, which we believe provides a meaningful point of differentiation for neratinib in the treatment of HER2-positive breast cancer.”

“While the use of trastuzumab in the adjuvant setting has led to a reduction in disease recurrence in patients with early stage HER2-positive breast cancer, there remains an unmet clinical need for further improvement in outcome in order to attempt to further reduce the risk of recurrence,” Auerbach added.

Puma Biotechnology Inc. was trading around $195 after market close on Tuesday, compared with the same day’s closing price of $59.03 and the company’s record closing high of $139.92 on Jan. 21, 2014.

Full results of the clinical trial will be presented at a future scientific meeting.

Puma plans to file for regulatory approval of neratinib as an extended adjuvant therapy in the first half of next year.

Citigroup raised its price target for Puma shares to $292, up from $99, following the positive trial results. Citi also said it views Puma as a likely acquisition target and believes the drug is likely to work in lung cancer and other cancers related to the HER2 mutation.

Read more recent phase III stories here.

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