Eileen O’Reilly here from Memorial Sloan-Kettering Cancer Center and Weill Medical College of Cornell. An active clinical trial that we at Memorial Sloan-Kettering Cancer Center are leading with national and international collaboration in Canada and with Israeli investigators is evaluating the role of platinum agents and PARP inhibitors in patients with advanced pancreas cancer who have a BRCA or PALB2 mutation. This is an NCI-sponsored study which is also being funded by the Lustgarten Foundation for Pancreas Cancer Research; that latter organization is funding the collective science behind the trial. So about 5-8% of people with pancreas cancer will have a BRCA or PALB2 mutation, and in individuals with a personal or family history of breast or ovary cancer and with Eastern European or Ashkenazi heritage, there is about 10-15% chance that that individual with pancreas cancer may have an underlying BRCA mutation. We believe these patients based on an emerging amount of preclinical and early clinical data may have selective additional benefit to platinum agents and PARP inhibitors in the setting of advanced pancreas cancer, and thus, we have two trials that are underway that are designed to answer these questions. The first is for a group of people with BRCA or PALB2 mutated pancreas cancer who have untreated, either locally advanced or metastatic disease; and at this time, we are finalizing the dose of the PARP inhibitor, olaparib which is being combined with cisplatin and gemcitabine, that is anticipated to be finalized in the very near future and then the study will go on to its randomized portion where the backbone will be gemcitabine and cisplatin plus or minus the addition of olaparib, and here we hope to characterize the exact value of platinum agents in this population and the incremental potential value of the addition of a PARP inhibitor to a platinum cytotoxic backbone.
We have a second study which is for a similar patient population with BRCA or PALB2 mutated pancreas cancer looking at a higher dose of single agent PARP inhibitor, again olaparib in patients with previously treated pancreas cancer. So this setting will be in the second- or third-line setting of pancreas cancer, and again it is to understand whether this population do indeed have benefit from this targeted agent recognizing the concept on which the trial design is underpinned of synthetically lethality where patients with BRCA- or PALB2-mutated disease may have a selective increased in ability to repair DNA damage from cytotoxic or PARP inhibitors, and thus, we believe their cancers hopefully will have greater value in terms of benefit from these agents. So these studies started relatively recently and will take couple of years to complete, but we believe that they may target an important subset of patients with pancreas adenocarcinoma.