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Lynparza: significant PFS 1st-line ovarian cancer
Lynparza: significant PFS 1st-line ovarian cancer.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \nRNS Number : 6822S AstraZeneca PLC 27 June 2018 \n\nThis announcement contains inside information\n27 June 2018 07:00 BST\n \nLynparza significantly delays disease progression in Phase III \n1st-line SOLO-1 trial for ovarian cancer \n \nLynparza met primary endpoint of progression-free survival in women with BRCA-mutated advanced ovarian cancer and showed a safety profile consistent with previous trials \n \nAstraZeneca and MSD's Lynparza is the only PARP inhibitor to demonstrate significant activity in the 1st-line maintenance setting \n \nAstraZeneca and Merck & Co., Inc., Kenilworth, N.J., US (Merck: known as MSD outside the US and Canada) today announced positive results from the randomised, double-blinded, placebo-controlled, Phase III SOLO-1 trial of Lynparza (olaparib) tablets. \n \nWomen with BRCA-mutated (BRCAm) advanced ovarian cancer treated 1st-line with Lynparza maintenance therapy had a statistically-significant and clinically-meaningful improvement in progression-free survival compared to placebo. The safety and tolerability profile of Lynparza was consistent with previous trials. Based upon these data, AstraZeneca and MSD plan to initiate discussions with health authorities regarding regulatory submissions.\n \nSean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: \"For the first time, we see a significant and clinically-impactful improvement in progression-free survival in the 1st-line maintenance setting for women with BRCA-mutated ovarian cancer treated with a PARP inhibitor. The SOLO-1 data reinforce the importance of knowing BRCA status at diagnosis, as this may enable women with BRCA-mutated ovarian cancer to receive Lynparza earlier. We would like to thank the investigators, hospitals and most of all the patients who took part in this trial, without whom medical advancements would not be possible.\" \n \nRoy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, MSD Research Laboratories, said: \"Building on the strong data we've seen with Lynparza to date, the data from SOLO-1 reinforces Lynparza's ability to provide meaningful disease control with a well-characterised safety and tolerability profile. We look forward to presenting the full data set for SOLO-...