AstraZeneca's Lynparza Slows Spread of Rare Pancreatic Cancer

(Bloomberg) -- AstraZeneca Plc’s Lynparza, a treatment for breast and ovarian cancers triggered by flaws in a gene called BRCA, appears to be effective against uncommon pancreatic cancers tied to the same mutations.

Patients who took two daily doses of the medicine were half as likely to have their cancer resume growing as those who were given a placebo after first getting chemotherapy. The tumors progressed after about 7.4 months in patients who were taking Lynparza, compared with 3.8 months for those given placebo. In some patients, the benefit lasted more than two years.

The results, presented at the American Society of Clinical Oncology meeting in Chicago and published in the New England Journal of Medicine, offer a sliver of hope for some people with pancreatic cancer, one of the most deadly tumor types. They also have the potential to bolster use of Lynparza, which Astra has an agreement with U.S.-based Merck & Co. to co-develop and commercialize and is expected to generate about $2.2 billion in annual sales by 2022.

The results of the trial, called POLO, should change the standard of care for these patients, said Hedy Kindler, the paper’s senior author and a professor of medicine in hematology/oncology at the University of Chicago.

“These are patients with an otherwise abysmal prognosis,” said Kindler, who is also associate vice chair for clinical research at the University of Chicago. Average survival for the most aggressively treated patients with cancer of the pancreas is about a year, she said.

Pancreatic cancer strikes 56,000 people in the U.S. annually and nearly half a million worldwide. Fewer than 7 percent of them carry a mutation in the BRCA gene that would qualify them for treatment with Lynparza. The gene normally produces a protein that helps repair damage to DNA. Mutations in it can increase cancer risk, and are most often found in people of Ashkenazi Jewish heritage.

Diagnostic Challenge

A key challenge for the companies will be to get oncologists to start looking for BRCA mutations in pancreatic cancer patients. Although BRCA mutations are primarily known for their role in promoting breast and ovarian cancer, testing may eventually be required in other types of tumors. AstraZeneca and Merck are studying Lynparza in a range of diseases, including prostate, endometrial and cervical cancer.

“Testing isn’t routine and that’s because there hasn’t been treatment to provide to these patients as a result of knowing that data,” said Dave Fredrickson, AstraZeneca’s executive vice president for oncology. “We really hope and believe that the results from POLO will create an imperative for these patients.”

The researchers screened more than 3,000 patients with spreading pancreatic cancer to find 154 with the mutation that made them eligible to take part in the trial. Patients took the medicine every day until the cancer resumed growing.

An early look at overall survival failed to show those given Lynparza were living significantly longer than those who received placebo. Many of the placebo patients started new medicines once their disease progressed, which may have confounded the results, the researchers said.

The disease remained in check, with no signs of progression, for 22.1 percent of patients who got the drug after two years, compared to 9.6 percent of those taking placebo. Importantly for patients battling advanced cancer, the medicine didn’t harm their quality of life, the study found.

To contact the reporter on this story: Michelle Fay Cortez in Minneapolis at mcortez@bloomberg.net

To contact the editors responsible for this story: Drew Armstrong at darmstrong17@bloomberg.net, John Lauerman, Timothy Annett

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