TABLE 2.
Phase II clinical trials of PARPis plus other drugs in OC/TNBC with published results.
| Clinicaltrials. Gov identifier/Study name | Condition or disease | Treatment arm | Patients | Key outcome measures |
|---|---|---|---|---|
| NCT02734004/MEDIOLA | BRCA1/2-mutated metastatic breast cancer | durvalumab + olaparib | 30 | DCR of 12 weeks: 80% (N = 24), 90% CI, 64.3–90.9 |
| NCT03579316 | Recurrent PARPi-resistant ovarian cancer | adavosertib | 35 | ORR: 23% (90% CI) |
| CBR: 63% (90% CI) | ||||
| PFS: 5.5 months (90%CI) | ||||
| Adavosertib + olaparib | 35 | ORR: 29% (90% CI) | ||
| CBR: 89% (90% CI) | ||||
| PFS: 6.8 months (90%CI) | ||||
| NCT02657889 | Triple-negative Breast Cancer | Pembrolizumab + niraparib | 55 | ORR:21%, (90% CI, 12%–33%) |
| DCR:49%, (90% CI, 36%–62%) | ||||
| CR:5 patients (9%) | ||||
| PR: 5 patients (9%) | ||||
| SD: 13 patients (24%) | ||||
| Ovarian cancer | 60 | ORR: 18% (90% CI, 11%–29%) | ||
| DCR: 65% (90% CI, 54%–75%) | ||||
| CR:3 patients (5%) | ||||
| PR: 8 patients (13%) | ||||
| SD: 28 patients (47%) | ||||
| NCT02354131/AVANOVA2 | Platinum-sensitive recurrent ovarian cancer | Niraparib plus bevacizumab | 48 | PFS:11·9 months (95% CI 8·5–16·7) |
| Niraparib | 49 | PFS: 5.5 months (95% CI 8·5–16·7) |