. 2024 Sep 17;16:1267–1283. doi: 10.2147/CMAR.S411023

Table 3.

Summary of Clinical Outcomes (Primary Endpoints) in Phase 3 Randomized Clinical Trials Evaluating Efficacy of PARPi and ARSI combinations in mCRPC Patients in 1st Line Treatment Setting

Phase III Clinical Trials	TALAPRO-2⁴⁸ (NCT03395197)	PROpel Study⁴⁹ (NCT03732820)	MAGNITUDE⁵⁰ (NCT03748641)
Primary endpoint (rPFS)	HRRd unselected cohort Talazo arm: Median PFS Not reached. Placebo arm: Median PFS 22 mo. HR 0.63 (95% CI, 0.51–0.78; p<0.0001)	Median rPFS 24.8 months (Olaparib arm) vs 16.6 (placebo arm); HR 0.66 (95% CI, 0.54–0.81; p<0.001)	In overall HRRd cohort, rPFS 16.5 vs 13.7, HR 0.73 (95% CI, 0.56–0.96; P=0.022); Non-HRRm cohort HR of 1.09 (95% CI, 0.75–1.57; P=0.66)
	*HRRd subgroup* Talazo arm: Median PFS 28 mo. Placebo arm: Median PFS 16 mo. HR 0.46 (95% CI, 0.30–0.70; p=0.0003)
	*Non-HRRd subgroup* Talazo arm: Median PFS not reached. Placebo arm: Median PFS 23 mo. HR of 0·.70 (0.54–0.89; p=0.0039)
Outcome in pts with BRCA1/2 alterations	HR for rPFS was 0.23 (95% CI, 0.10–0.53; p=0.0002)	NR	Median rPFS in the BRCA1/2 16.6 mo (Niraparib arm) vs 10.9 mo (Placebo arm), HR 0.53 (95% CI, 0.36–0.79; P=0.001)
Outcome in non-BRCA1/2 alterations	HR for rPFS was 0.66 (95% CI, 0.39–1.12, P=0.12)	NR	HR 0.99 (95% CI, 0.68–1.44) in subgroup with non-BRCA for rPFS

Abbreviations: CI, Confidence interval; HRRd, Homologous recombination repair gene mutation; mo, months; HR, Hazard Ratio; rPFS, Radiographic progression free survival; Tala, Talazoparib.