PARPi and survival outcomes in mCRPC: main trial presented at ASCO GU 2023
Trial | Line setting | HRR status/BRCA status | Median FU (months) | rPFS(Months; experimental vs. standard) | OS(Months; experimental vs. standard) |
---|---|---|---|---|---|
PROpel(Olaparib/placebo + abiraterone) | 1L mCRPC | HRRm (30%)/non-HRRmBRCAm (10%)/overall population | 36.6 m | ITT: 24.8 vs. 16.6; HR: 0.66, 95% CI: 0.54–0.81, P < 0.001HRRm: NR vs. 13.9; HR: 0.50, 95% CI: 0.34–0.73non-HRRm: 24.1 vs. 19.0; HR: 0.76, 95% CI: 0.60–0.97BRCAm: NR vs. 8.4; HR: 0.23, 95% CI: 0.12–0.43non-BRCAm: 24.1 vs. 19.0; HR: 0.76, 95% CI: 0.61–0.94 | ITT: 42.1 vs. 34.7 maturity 47.9%; HR: 0.81, 95% CI: 0.67–1.00; P = 0.0544HRRm: NR vs. 28.5; HR: 0.66, 95% CI: 0.45–0.95non-HRRm: 42.1 vs. 38.9; HR: 0.89, 95% CI: 0.70–1.14BRCAm: NR vs. 23.0; HR: 0.29, 95% CI: 0.14–0.56non-BRCAm: 39.6 vs. 38.0; HR: 0.91, 95% CI: 0.73–1.13 |
TALAPRO-2(Talazoparib/placebo + enzalutamide) | 1L mCRPC | HRRm (20%)/non-HRRmBRCA1m (5%)BRCA2m (23%) | 24 m | ITT: not reached vs. 21.9; HR: 0.63, 95% CI: 0.51–0.78; P < 0.001HHRm: 27.9 vs. 16.4; HR: 0.46, 95% CI: 0.30–0.70, P < 0.001non-HRRm: not reached vs. 22.5; HR: 0.70, 95% CI: 0.54–0.89; *P = 0.009 | ITT: HR: 0.89; P = 0.35 (no mature data—only 31% of events) |
MAGNITUDE (IA2)Niraparib/Placebo + Abiraterone and prednisone | 1L mCRPC | HRRm (100%)BRCAm (53.2%) | 35 m | HHRm: 16.7 vs. 13.7; HR: 0.76, 95% CI: 0.60–0.97BRCAm: 19.5 vs. 10.9; HR: 0.55, 95% CI: 0.39–0.78, P = 0.0007 | HHRm: 29.3 vs. 32.2; HR: 1.01, 95% CI: 0.75–1.36BRCAm: 30.4 vs. 28.6; HR: 0.788; 95% CI: 0.554–1.120; P = 0.1828 |
PARPi: poly (ADP-ribose) polymerase inhibitor; mCRPC: metastatic castration resistant prostate cancer; HRR: homologous recombination repair; HRRm: HRR mutated; BRCA: breast cancer; rPFS: radiological progression-free survival; OS: overall survival; ITT: intention to treatment; BRCAm: BRCA mutated; FU: follow-up; * same BRCAm rates in the two treatment groups; NR: not reported