Olaparib

The PARP inhibitor olaparib was tested in an open-label, phase III, randomized controlled trial in men with mCRPC and variants in one of 15 prespecified homologous recombination repair genes, including BRCA1 or BRCA2. The men had previously received enzalutamide, abiraterone, or both, with or without previous taxane chemotherapy.[81] The trial enrolled 387 men and randomly assigned them in a 2:1 ratio to receive olaparib (300 mg twice daily) or physician's choice of enzalutamide or abiraterone plus prednisone. Cohort A included 245 patients with at least one variant in BRCA1, BRCA2, or ATM. Cohort B included 142 patients with at least one variant in one of the other 12 prespecified genes.

The PARP inhibitor olaparib was tested in an open-label, phase III, randomized controlled trial in men with mCRPC and variants in one of 15 prespecified homologous recombination repair genes, including BRCA1 or BRCA2. The men had previously received enzalutamide, abiraterone, or both, with or without previous taxane chemotherapy.[81] The trial enrolled 387 men and randomly assigned them in a 2:1 ratio to receive olaparib (300 mg twice daily) or physician's choice of enzalutamide or abiraterone plus prednisone. Cohort A included 245 patients with at least one variant in BRCA1, BRCA2, or ATM. Cohort B included 142 patients with at least one variant in one of the other 12 prespecified genes.

The median OS in cohort A was 19.1 months for patients who received olaparib and 14.7 months for patients who received the control regimen (HR, 0.69; 95% CI, 0.50–0.97). A sensitivity analysis adjusting for crossover to olaparib in the control arm reported an HR of 0.42 (95% CI, 0.19–0.91).

The PARP inhibitor olaparib was tested in an open-label, phase III, randomized controlled trial in men with mCRPC and variants in one of 15 prespecified homologous recombination repair genes, including BRCA1 or BRCA2. The men had previously received enzalutamide, abiraterone, or both, with or without previous taxane chemotherapy.[81] The trial enrolled 387 men and randomly assigned them in a 2:1 ratio to receive olaparib (300 mg twice daily) or physician's choice of enzalutamide or abiraterone plus prednisone. Cohort A included 245 patients with at least one variant in BRCA1, BRCA2, or ATM. Cohort B included 142 patients with at least one variant in one of the other 12 prespecified genes.

There was no significant OS benefit in cohort B.

The PARP inhibitor olaparib was tested in an open-label, phase III, randomized controlled trial in men with mCRPC and variants in one of 15 prespecified homologous recombination repair genes, including BRCA1 or BRCA2. The men had previously received enzalutamide, abiraterone, or both, with or without previous taxane chemotherapy.[81] The trial enrolled 387 men and randomly assigned them in a 2:1 ratio to receive olaparib (300 mg twice daily) or physician's choice of enzalutamide or abiraterone plus prednisone. Cohort A included 245 patients with at least one variant in BRCA1, BRCA2, or ATM. Cohort B included 142 patients with at least one variant in one of the other 12 prespecified genes.

There was no significant OS benefit in the overall population.

The PARP inhibitor olaparib was tested in an open-label, phase III, randomized controlled trial in men with mCRPC and variants in one of 15 prespecified homologous recombination repair genes, including BRCA1 or BRCA2. The men had previously received enzalutamide, abiraterone, or both, with or without previous taxane chemotherapy.[81] The trial enrolled 387 men and randomly assigned them in a 2:1 ratio to receive olaparib (300 mg twice daily) or physician's choice of enzalutamide or abiraterone plus prednisone. Cohort A included 245 patients with at least one variant in BRCA1, BRCA2, or ATM. Cohort B included 142 patients with at least one variant in one of the other 12 prespecified genes.

The most common adverse events for patients who received olaparib were anemia (50%), nausea (43%), and fatigue or asthenia (42%).