Abstract No : Abstract #610O

Indication : Prostate Cancer

Intervention : Olaparib

Company : AstraZeneca and Merck

Technology : PARP inhibitor

 

Results:

At data cut-off on 20 March 2020`, median final OS in Cohort A was significantly longer with olaparib than with physician’s choice of enzalutamide or abiraterone (HR 0.69; 95% CI 0.50, 0.97; P=0.0175), with a trend towards improvement in the overall population (HR 0.79; 95% CI 0.61, 1.03; nominal P=0.0515). Of pts in the control arm, 56 (67%) in Cohort A and 86 (66%) in the overall population crossed over to olaparib. Longer follow-up yielded no new safety signals.

 

Conclusion:

PROfound is the first phase 3 trial to show a PARP inhibitor benefit in alpha-controlled OS analyses. Despite extensive crossover from the control arm, olaparib conferred a statistically significant and clinically meaningful prolongation of OS vs sequential therapy with enzalutamide or abiraterone in men with mCRPC with progression on prior therapy and alterations in BRCA1, BRCA2 or ATM, with a 31% reduction in the risk for death.