NEW YORK (GenomeWeb) – Myriad Genetics and AstraZeneca are expanding their agreement to use BRACAnalysis CDx™ to identify best responders to the PARP inhibitor Lynparza (olaparib) as a metastatic pancreatic cancer treatment.
The two companies have already worked together to bring BRACAnalysis CDx™ as a US Food and Drug Administration-approved test that identifies germline BRCA mutations in advanced ovarian cancer patients considering treatment with Lynparza. The agency approved the drug in the advanced ovarian cancer setting along with the test in December.
Under their latest agreement, AstraZeneca will use BRACAnalysis CDx™ to prospectively identify the metastatic pancreatic cancer patients who are likely to respond to Lynparza. Pancreatic cancer patients generally have poor prognosis, with an average life expectancy of three-to-six months after diagnosis. The American Cancer Society estimates that there are 48,000 newly diagnosed pancreatic cancer patients each year in the US, and 40,000 die from the disease annually.
The randomized Phase III study that the BRACAnalysis CDx™ will be used in will involve 145 pancreatic cancer patients who have not progressed on first-line platinum-based chemotherapy. Patients will be randomized to receive Lynparza 300 mg twice daily or a placebo.
In order to be randomized into the study, patients must have a germline, deleterious BRCA mutation or suspected deleterious BRCA mutation as determined by Myriad’s test. Researchers will follow patients for up to four years to assess their progression-free survival, overall survival, a number of other efficacy measures, as well as safety and tolerability of Lynparza. The study started in December and is slated for completion in July 2016.