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AstraZeneca, MSD Say Phase III POLO Trial Meets Primary Endpoint Of PFS

British drug maker AstraZeneca Plc (AZN.L,AZN) and MSD Inc., known as Merck & Co., Inc. (MRK) inside the U.S. and Canada, on Tuesday announced positive results from the Phase III POLO trial, saying that the trial met its primary endpoint of progression-free survival or PFS.

The companies noted that results from the POLO trial showed a statistically-significant and clinically-meaningful improvement in PFS with Lynparza (olaparib) compared to placebo. The safety and tolerability profile of Lynparza was consistent with previous trials.

POLO is a randomised, double-blinded, placebo-controlled trial exploring the efficacy of Lynparza tablets as 1st-line maintenance monotherapy in patients with germline BRCA-mutated (gBRCAm) metastatic adenocarcinoma of the pancreas (pancreatic cancer) whose disease has not progressed on platinum-based chemotherapy.

Jose´ Baselga, Executive Vice President, Research and Development, Oncology, said, "This is the first positive Phase III trial of any PARP inhibitor in germline BRCA-mutated metastatic pancreatic cancer, a devastating disease with critical unmet need. The results of POLO provide further evidence of the clinical benefit of Lynparza across a variety of BRCA-mutated tumour types. We will discuss these results with global health authorities as soon as possible."

AstraZeneca and MSD plan to present the full data from the trial at a forthcoming medical meeting.

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