Results from landmark phase III randomized clinical trials assessing switch maintenance PARP inhibition in advanced front-line or recurrent epithelial ovarian cancer16–31
| Clinical trial | Population | PFS HR (95% CI) | PFS2 HR (95% CI) | TSST HR (95% CI) | OS HR (95% CI) |
| Front-line | |||||
| SOLO1 (NCT01844986) Olaparib vs PCB | BRCAm | HR 0.33 (0.25 to 0.43) | HR 0.46 (0.34 to 0.65) | HR 0.46 (0.34 to 0.63) | HR 0.55 (0.40 to 0.76) Not final analysis. p=0.0004, with p<0.0001 required for statistical significance |
| PRIMA (NCT02655016) Niraparib vs P | ITT | HR 0.62 (0.50 to 0.76) | HR 0.81 (0.58 to 1.14) Immature (20% maturity in ITT) | NA | Immature |
| HRd | HR 0.43 (0.31 to 0.59) | HR 0.84 (0.49 to 1.45) Immature (20% maturity in ITT) | NA | Immature | |
| PRIME (NCT03709316) Niraparib vs P | ITT | HR 0.45 (0.34 to 0.60) | NA | NA | Immature |
| HRd | HR 0.48 (0.34 to 0.68) | NA | NA | Immature | |
| ATHENA-MONO (NCT03522246) Rucaparib vs P | ITT | HR 0.52 (0.40 to 0.68) | NA | NA | Immature |
| HRd | HR 0.47 (0.31 to 0.72) | NA | NA | Immature | |
| PAOLA-1 (NCT02477644) Olaparib+B vs P+B | ITT | HR 0.59 (0.49 to 0.72) | HR 0.78 (0.64 to 0.95) | HR 0.78 (0.64 to 0.95) | HR 0.92 (0.76 to 1.12) |
| HRd | HR 0.33 (0.25 to 0.45) | HR 0.56 (0.41 to 0.77) | HR 0.48 (0.35 to 0.66) | HR 0.62 (0.45 to 0.85) | |
| Platinum-sensitive recurrence | |||||
| SOLO2 (NCT01874353) Olaparib vs P | BRCAm | HR 0.30 (0.22 to 0.41) | HR 0.50 (0.34 to 0.72) | HR 0.51 (0.39 to 0.68) | HR 0.74 (0.54 to 1.00) |
| NOVA (NCT01847274) Niraparib vs P | gBRCAm | HR 0.27 (0.17 to 0.41) | HR, 0.67 (0.48 to 0.94) | NA | HR, 0.85 (0.61 to 1.2) |
| Non-gBRCAm | HR 0.45 (0.34 to 0.61) | HR, 0.81 (0.62 to 1.05) | NA | HR 1.06 (0.81 to 1.37) | |
| ARIEL3 (NCT01968213) Rucaparib vs P | BRCAm | HR 0.23 (0.16 to 0.34) | HR 0.67 (0.48 to 0.94) | HR 0.53 (CI 0.36 to 0.80) | HR 0.83 (0.58 to 1.19) 73% maturity |
| HRd | HR 0.32 (0.24 to 0.42) | HR 0.72 (0.56 to 0.92) | HR 0.67 (0.50 to 0.91) | HR 1 (0.76 to 1.32) | |
| ITT | HR 0.36 (0.30 to 0.45) | HR 0.7 (0.58 to 0.85) | HR 0.68 (0.54 to 0.85) | HR 0.99 (0.81 to 1.22) | |
The primary endpoint of all the studies was PFS.11–25
B, bevacizumab; BRCAm, BRCA mutation carrier; CI confidence interval; gBRCAm, germline BRCA mutation carrier; HRd, homologous recombination deficiency; ITT, Intention to treat; NA, not available; OS, overall survival; P, placebo; PFS2, progression on the second-line therapy; PFS, progression-free survival; TSST, time to second subsequent treatment.