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AstraZeneca PLC (AZN) Investors Pumped as Breast Cancer Drug Sails Through Phase III Trial



2/17/2017 6:16:54 AM

AstraZeneca PLC Investors Pumped as Breast Cancer Drug Sails Through Phase III Trial February 17, 2017
By Alex Keown, BioSpace.com Breaking News Staff

WILMINGTON, Del. – Shares of AstraZeneca (AZN) received a small boost in price after the company announced its cancer drug Lynparza in tablet form met primary endpoints in a Phase III trial to treat patients with HER2-negative metastatic breast cancer harboring germline BRCA1 or BRCA2 mutations.


The primary endpoint of the trial was progression-free survival (PFS) as measured by a Blinded Independent Central Review. AstraZeneca will seek approval for this indication of Lynparza later this year.

Lynparza is a PARP inhibitor, a new class of cancer drugs. PARP stands for poly ADP ribose polymerase, which is an enzyme many cancer cells are more dependent upon than regular, healthy cells are. Drugs that inhibit PARP have the potential to be a new and effective form of cancer treatment. If approved for this type of breast cancer, Lynparza will be the first PARP inhibitor for that type of cancer. Lynparza has already been approved by the U.S. Food and Drug Administration (FDA) for the treatment of one form of ovarian cancer. In 2016, the drug generated $218 million for AstraZeneca, the Telegraph of London reported.

If the drug receives FDA approval for the breast cancer indication, analysts at Berenberg told the Telegraph that Lynparza could become a blockbuster treatment, generating $1 billion in revenue annually.

Having approval for a second type of cancer will certainly be a boost for AstraZeneca’s R&D efforts, particularly since a rival PARP inhibitor developed by AbbVie failed a late stage trial in December.

Breast cancer patients in the trial who were treated with Lynparza showed a “statistically-significant and clinically-meaningful improvement in progression-free survival” to those patients treated with chemotherapy.

“These results are positive news for patients with BRCA-mutated metastatic breast cancer, a disease with a high unmet need, and are the first positive Phase III data for a PARP inhibitor beyond ovarian cancer. This is highly encouraging for the development of our broad portfolio which aims to treat multiple cancers by targeting DNA damage response pathways.” Sean Bohen, AstraZeneca’s chief medical officer said in a statement.
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Shares of AstraZeneca jumped about 4 percent Thursday on the news of the Lynparza trial. The stock is slightly down from its opening price of $29.16, it’s currently trading at $29.07 as of 11:57 a.m.

Breast cancer is one of the most commonly diagnosed types of cancer in the U.S. AstraZenca said approximately one in eight American women are diagnosed with breast cancer, with about one-third of these patients diagnosed with the metastatic stage of the disease. The company said the primary aim of treatment is to slow progression of the disease for as long as possible, improving or at least maintaining, a patient’s quality of life.

In addition to the HER2-negative metastatic breast cancer harboring germline BRCA1 or BRCA2 mutations form, AstraZeneca in investigating Lynparza’s efficacy in another separate non-metastatic breast cancer Phase III study called Olympia. Lynparza is also being investigated in other forms of ovarian cancer as well as pancreatic and prostate cancer.


Read at BioSpace.com


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