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Lynparza Phase III PROfound trial in HRR*
Lynparza Phase III PROfound trial in HRR*.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \nRNS Number : 2080I AstraZeneca PLC 07 August 2019 \n\n07 August 2019 07:00 BST \n \nLynparza Phase III PROfound trial in HRR* mutation-selected metastatic castration-resistant prostate cancer met primary endpoint\n \nAstraZeneca and MSD's Lynparza met the primary endpoint of significantly increasing the time patients selected for BRCA1/2 or ATM mutations live without radiographic disease progression vs. standard of care treatment\n \nOnly PARP inhibitor with positive Phase III results in four different cancer types (ovarian, breast, pancreatic and prostate)\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 PROfound trial of Lynparza (olaparib) in men with metastatic castration-resistant prostate cancer (mCRPC) who have a *homologous recombination repair gene mutation (HRRm) and have progressed on prior treatment with new hormonal anticancer treatments (e.g. enzalutamide and abiraterone).\n \nResults from the trial showed a statistically-significant and clinically-meaningful improvement in the primary endpoint of radiographic progression-free survival (rPFS) with Lynparza vs. enzalutamide or abiraterone in men with mCRPC selected for BRCA1/2 or ATM gene mutations, a subpopulation of HRR gene mutations. The safety and tolerability profile of Lynparza was generally consistent with previous trials. \n \nJosé Baselga, Executive Vice President, Oncology R&D, said: \"For men with metastatic castration-resistant prostate cancer the disease remains deadly, especially in those who have failed on a new hormonal anticancer treatment. This trial is the only positive Phase III trial of any PARP inhibitor in metastatic castration-resistant prostate cancer, where the need for new, effective therapies is high. The PROfound trial also demonstrates the potential value of genomic testing in this at-risk patient population. We look forward to discussing these results with global health authorities soon.\" \n \nRoy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, MSD Research Laboratories, said: \"Metastatic castration-resistant prostate cancer is a deadly disease and represents an area of critical unmet medical need. The Phase III PROfound t...