AstraZeneca and its research partner Merck & Company announced positive data from their Phase III POLO trial of Lynparza in pancreatic cancer. Merck is known as MSD outside of the U.S. and Canada.
The companies said that the trial showed a statistically significant and clinically meaningful improvement in progression-free survival (PFS) as first-line maintenance therapy alone in patients with germline BRCA-mutated (gBRCAm) metastatic adenocarcinoma of the pancreas in patients who haven’t responded to platinum-based chemotherapy.
The trial compared Lynparza (olaparib) to placebo. POLO is a Phase III randomized, double-blinded, placebo-controlled, multi-center trial of Lynparza tablets (300mg twice daily) alone compared to placebo. It randomized 154 patients with gBRCAm metastatic pancreatic cancer that had not progressed on first-line platinum-based chemotherapy. Patients were randomized three-to-two to receive Lynparza or placebo until the disease progressed.
The primary endpoint of the trial was PFS and key secondary endpoints included overall survival (OS), time to secondary disease progression, overall response rate (ORR), disease control rate and health-related quality of life.