April 17, 2015
By Riley McDermid, BioSpace.com Breaking News Sr. Editor
AstraZeneca PLC has an experimental lung cancer pill that has delayed progression of the disease by more than a year, the company said at the European Lung Cancer Congress 2015 in Geneva, Switzerland on Friday.
Today’s data was culled from the firm’s Phase II study on around 300 patients, which showed a 54 percent overall response rate, which greatly exceeded its 9.6-month PFS rate AstraZeneca reported last fall.
The drug, AZD9291, zeroes in on a genetic mutation that keeps tumors resistant against other lung cancer therapies. The company said in its presentation today that it has been able to show AZD9291 produces a median progression-free survival 13.5 months, a huge boost for a patient population that typically sees much lower odds. It targets patients with advanced epidermal growth factor receptor mutation positive (EGFRm) non-small cell lung cancer (NSCLC), who also have the T790M resistance mutation.
“We are committed to developing novel medicines that address the significant unmet need in lung cancer by focusing on the genetic drivers underlying the disease,” said Antoine Yver, head of oncology, global medicines development at AstraZeneca, in a statement.
“Our extensive clinical research program is also investigating the potential of AZD9291 in earlier disease and in combination with other pipeline assets including immuno-oncology molecules,” he added. “With this comprehensive approach, our goal is to develop a broad range of potential treatment options for patients with EGFR mutation positive non-small cell lung cancer.”
The news could give it an edge when fighting off competition in the space, like Clovis Oncology ’s CO-1686, which is in development now and targets the same mutation. The money at stake is not insignificant: AstraZeneca was forced to admit last year when repelling an acquisition effort by Pfizer that it expects AZD9291 to bring in $3 billion annually once it is approved.
AstraZeneca will submit the drug to regulators next quarter.
BioSpace Temperature Poll
After last week’s news that Gilead had issued a health advisory to doctors, concern is growing after nine patients taking Harvoni or Sovaldi along with another drug, amiodarone, were treated for abnormally slow heartbeats. One of the patients died of cardiac arrest. Three of the nine patients required a pacemaker. That has BioSpace asking, what next?
