Lynparza (olaparib) demonstrated statistically significant and clinically meaningful improvement in the primary endpoint of radiographic progression-free survival in certain tumors.
Lynparza reduced the risk of disease progression or death in the phase III PROfound clinical trial results by a median of 7.4 months versus 3.6 months for those receiving abiraterone or enzalutamide; Lynparza reduced the risk of disease progression or death by 66% for these men.
The drug is being developed by AstraZeneca and Merck.
The trial also met key secondary endpoint of rPFS in overall HRRm population, where Lynparza reduced the risk of disease progression or death by 51% and improved rPFS to a median of 5.8 months versus 3.5 months for those receiving abirateron or enzalutamide.
Secondary endpoint of median time to pain progression was not reached.
PROfound showed a confirmed overall response rate, a key secondary endpoint of 33.3% for Lynparza versus 2.3% for abiratone or enzalutammide in patients with BRCA1/2 or ATM mutations.
Safety and tolerability profile of Lynparza in the PROfound trial was in line with that observed in prior clinical trials.
