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Lynparza Phase III PAOLA-1 trial met primary endpo
Lynparza Phase III PAOLA-1 trial met primary endpo.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \nRNS Number : 9929I AstraZeneca PLC 14 August 2019 \n\n14 August 2019 07:00 BST\n \nLynparza Phase III PAOLA-1 trial met primary endpoint as 1st-line maintenance treatment with bevacizumab for advanced ovarian cancer\n \nAstraZeneca and MSD's Lynparza, when added to standard-of-care bevacizumab, significantly increased the time women lived without disease progression\n \nAstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc. inside the US and Canada) today announced positive results from the Phase III PAOLA-1 trial in women with advanced ovarian cancer. The trial, in the 1st-line maintenance setting, compared Lynparza (olaparib) added to standard-of-care (SoC) bevacizumab vs. bevacizumab alone in women with or without BRCA gene mutations.\n \nThe trial met its primary endpoint in the intent-to-treat* population with a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS), increasing the time women taking Lynparza plus bevacizumab lived without disease progression or death vs. those taking bevacizumab alone. The results, including biomarker sub-group analyses, will be presented at a forthcoming medical meeting. The safety and tolerability profiles observed in PAOLA-1 were generally consistent with those known for each medicine. PAOLA-1 is the second positive Phase III trial with Lynparza in 1st-line advanced ovarian cancer.\n \nJosé Baselga, Executive Vice President, Oncology R&D, said: \"The positive results from the PAOLA-1 trial demonstrate a clear potential benefit of adding Lynparza to the standard-treatment bevacizumab for women with advanced ovarian cancer. Following positive results from the SOLO-1 trial for women with a BRCA gene mutation, the PAOLA-1 trial marks yet another positive Phase III trial for Lynparza as a 1st-line maintenance treatment for women with advanced ovarian cancer. We look forward to discussing the results with global health authorities as soon as possible.\"\n \nRoy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, MSD Research Laboratories, said: \"The Phase III PAOLA-1 trial demonstrates MSD's and AstraZeneca's continued commitment to improving clinical outcomes for women with advanced ovarian cancer. In this co-operative group trial sp...