The phase III PROfound trial of Lynparza (olaparib) in men with metastatic castration-resistant prostate cancer who have a homologous recombination repair gene mutation and have progressed on prior treatment with new hormonal agent treatments (e.g. enzalutamide and abiraterone) has demonstrated improvement in overall survival.
AstraZeneca and Merck sponsor Lynparza.
Results from the trial showed a statistically significant and clinically meaningful improvement in the key secondary endpoint of overall survival with Lynparza versus enzalutamide or abiraterone in men with mCRPC selected for BRCA1/2 or ATM gene mutations, a subpopulation of HRR gene mutations, the companies said.
The phase III PROfound trial had met its primary endpoint in August 2019, showing significantly improved radiographic progression-free survival in men with mutations in BRCA1/2 or ATM genes, and had met a key secondary endpoint of rPFS in the overall HRRm population.
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