AstraZeneca (AZN -1.1%) and Merck (MRK +1.5%) report PROfound Phase 3 clinical trial results showed statistically significant and clinically meaningful improvement with Lynparza (olaparib) in the primary endpoint of radiographic progression-free survival (rPFS) in certain tumors reducing the risk of disease progression or death by a median of 7.4 months vs. 3.6 months for those receiving abiraterone or enzalutamide; LYNPARZA reduced the risk of disease progression or death by 66% for these men.
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 vs. 3.5 months for those receiving abirateron or enzalutamide.
Secondary endpoint of median time to pain progression was not reached.
Trial showed a confirmed overall response rate, a key secondary endpoint of 33.3% for Lynparza vs. 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.
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