AstraZeneca Advances Three Cancer Drugs Into Late-Stage Trials

AstraZeneca Plc will move three experimental cancer treatments into late-stage development as generic competition for its best-selling drugs intensifies.

The U.K.’s second-biggest drugmaker is advancing development of moxetumomab pasudotox for hairy cell leukemia, olaparib for platinum-sensitive relapsed ovarian cancer and selumetinib for non-small cell lung cancer patients with the KRAS genetic mutation, the London-based company said today in a statement.

AstraZeneca has narrowed its research focus and cut thousands of jobs to return to growth as patents on its biggest selling medicines expire. The company will concentrate on respiratory, inflammation and autoimmune diseases, cardiovascular and metabolic illnesses, and cancer. It also plans to double the number of experimental treatments in late-stage development by 2016 and expects to file three marketing approval applications by then.

“It’s starting to become an exciting and deep pipeline,” Menelas Pangalos, executive vice president of innovative medicines at AstraZeneca, said in an interview.

Moxetumomab pasudotox is an “armed antibody” that targets cancer cells and kills them from within, Edward Bradley, senior vice president and head of Oncology Innovative Medicines at MedImmune, said in an interview. The treatment was developed by Cambridge Antibody Technology which was acquired by AstraZeneca in 2006.

First Patient

The trial, which is sponsored by the Cancer Therapy Evaluation Program at the National Cancer Institute and has already enrolled its first patient, will test the drug in those who have not responded to treatment or whose disease has returned. The U.S. Food and Drug Administration said only one late-stage trial would be necessary after 50 patients in a early-stage trial saw their tumors shrink and the disease had disappeared in more than half of them, Bradley said.

“It goes beyond two years and many patients with complete response rates are still in remission,” he said.

Olaparib, a PARP inhibitor which prevents cancer cells from repairing themselves, will enter a late-stage trial during the second half of the year in ovarian cancer patients with the BRCA gene mutations whose disease recurs following treatment with platinum-based chemotherapy. The company has already notified European regulators that it intends to file a marketing application for the drug.

The treatment failed to prolong the lives of ovarian cancer patients in a mid-stage trial. In analyzing samples, the company found that patients with the BRCA mutation saw a benefit and decided to continue testing it in that group, Susan Galbraith, head of AstraZeneca’s Oncology Innovative Medicines Unit, said in an interview.

AstraZeneca is also testing olaparib in breast cancer patients with the same genetic mutation as well as in gastric and non-small cell lung cancers and advanced solid tumors.

Selumetinib, which the company licensed from Array Biopharma, will begin testing in a late-stage trial in non-small cell lung cancer patients with a KRAS gene mutation during the second half of the year. AstraZeneca is also testing the treatment in melanoma patients with the same genetic mutation and for advanced pancreatic cancer.

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