Table 2.
Summary of Patient Selection Criterion in Phase 3 Clinical Trials
| Phase III Clinical Trials | TALAPRO-248 (NCT03395197) | PROpel Study49 (NCT03732820) | MAGNITUDE50 (NCT03748641) |
|---|---|---|---|
| Sample size | Total: 805, Tala + Enza (n=402), Placebo + Enza (n=403) | Total: 796, Olaparib + Abi/Pred (n=399), Placebo + Abi/Pred (n=397) | Total: 423, Niraparib + Abi/pred (n=212), Placebo + Abi/Pred (n=211) |
| Median Age (Years) | Talazo arm (71 yrs), Placebo arm (71yrs) | Olaparib arm (69 yrs), Placebo arm (70 yrs) | Niraparib arm (69 yrs), Placebo arm (69 yrs) |
| Race distribution (%) | Talazo arm: White (60%), Asian (32%), AA (3%), Placebo arm: White (63%), Asian (30%), AA (1%) | Olaparib arm: White (71%), Asian (17%), AA (4%), Placebo arm: White (69%), Asian (18%), AA (3%) | Entire cohort: White (74%), Asian (17%), AA (1%) |
| Treatment cohorts | Talazo arm vs Placebo arm | Olaparib arm vs Placebo arm | Niraparib arm vs Placebo arm |
| Disease site | Talazo arm: Bone (87%), Visceral (14%), Placebo arm: Bone (85%), Visceral (19%) | Olaparib arm: Bone (88%), Visceral (13%), Placebo arm: Bone (85%), Visceral (13%) | Niraparib arm: Bone (86%), Visceral (24%), Placebo arm: Bone (81%), Visceral (19%) |
| Biomarker selected enrollment | No | No | Yes |
| HRRd gene set pool | $12 HRR gene panel | #14 HRR gene panel | ^9 HRR gene panel |
| HRR gene aberration frequency (%) | Talazo arm (21%), Placebo arm (21%) | Olaparib arm (28%), Placebo arm (29.0%) | 24.9% pts undergone HRR gene status prescreening, Patients with HRRd randomized to niraparib and placebo arm. |
| BRCA1/2 loss (%) | Talazo arm 7% and Placebo arm (8%) | BRCA1: Olaparib arm (2%), placebo arm (1%), BRCA2: Olaparib arm (9.5%), placebo arm (8.8%) | Niraparib arm: BRCA1 (6%), BRCA2 (41%), Placebo arm: BRCA1 (2%), BRCA2 (42%) |
| Prior abiraterone or enzalutamide (%) | Talazo arm (6%), Placebo arm (7%) | *Olaparib arm (1%), *Placebo arm (0%) | @Niraparib arm (24%), @Placebo arm (23%) |
| Prior docetaxel for mCSPC | Talazo arm (21%), Placebo arm (23%) | Olaparib arm (23%), Placebo arm (22%) | Niraparib arm (19%), Placebo arm (21%) |
Notes: $BRCA1/2, PALB2, ATM, ATR, CHEK2, FANCA, RAD51C, NBN, MLH1, MRE11A, CDK12. #BRCA1/2, ATM, BARD1, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, RAD51B, RAD51C, RAD51D, RAD54L. ^BRCA1/2, ATM, BRIP1, CDK12, CHEK2, FANCA, HDAC2, PALB2. @ ARSI received Up to 4 months prior to randomization for mCRPC. *The trial excluded patients who received prior treatment with abiraterone and prednisone. Second-generation ARSIs in the CSPC setting were permitted, given that no disease progression occurred during and immediately after treatment.
Abbreviations: AA, African American; Abi/Pred, Abiraterone and Prednisone; Enza, Enzalutamide; HRRd, Homologous recombination repair gene mutation; mCSPC, Metastatic castrate sensitive prostate cancer; Tala, Talazoparib.