Table 1.
Clinical trials evaluating the combination of PARP inhibitors and immune checkpoint inhibitors in breast cancer ovarian cancer.
| Studies in Breast Cancer | Immunotherapy | PARPi | Patients | Outcome |
|---|---|---|---|---|
|
NCT02657889 (TOPACIO/KEYNOTE-162) Phase II |
Pembrolizumab (200 mg Q3W) | Niraparib (200 mg QD) |
N=55 Advanced/Metastatic TNBC | ORR 21% with 5 CRs and 5 PRs (better BRCA-mutated tumors), DCR 49% |
|
NCT02734004 (MEDIOLA) Phase II |
Durvalumab (1500 mg Q4W) | Olaparib (300 mg BID) |
N=34
gBRCAm HER2 negative mBC |
28-week DCR 47%, ORR 56%, PFS 6.7 months. |
|
NCT03330405 (JAVELIN PARP Medley) Phase Ib/II |
Avelumab (800 mg Q2W) |
Talazoparib (1mg QD) |
N=34 Previously Treated advanced solid tumors |
First-cycle DLT 25% ORR 8% with 1 PR, SD 50% |
| Studies in ovarian cancer | ||||
|
NCT02571725 Phase I |
Tremelimumab (10 mg/kg Q4W) |
Olaparib (300 mg BID) |
N=3
gBRCAm recurrent ovarian cancer |
No DLT or grade 3 AE ORR 100% with 3 PRs |
|
NCT02484404 Phase II |
Durvalumab (1500 mg Q4W) |
Olaparib (300 mg BID) | N=35 Platinum-resistant recurrent ovarian cancer | ORR 14% with 5 PRs, DCR 71%, mPFS 3.9 months |
|
NCT02657889 (TOPACIO/KEYNOTE-162 Phase II |
Pembrolizumab (200 mg Q3W) |
Niraparib (200 mg QD) |
N=60 Platinum-resistant recurrent ovarian cancer | ORR 18% with 3 CRs and 8 PRs (irrespective of BRCA and HRD status), DCR 65% mPFS 3.4 months |
|
NCT02734004 (MEDIOLA) Phase II |
Durvalumab (1500 mg Q4W) |
Olaparib (300 mg BID) |
N=32 gBRCAm platinum-sensitive ovarian cancer | 12-week DCR 81%, ORR 63% with 6 CRs and 14 PRs |
|
NCT02660034 Phase I |
Tislelizumab (200 mg q3W) | Pamiparib (40mg BID) | N=49 advanced and previously treated solid tumors | ORR 20%. RP2D |
TNBC, triple-negative breast cancer; gBRCAm, germline breast cancer gene mutation; BRCA, breast cancer gene; N, number of patients; ORR, overall response rate; CR, complete response; PR, partial response; SD, stable disease; DCR, disease control rate; PFS, progression-free survival; HRD, homologous recombination deficiency; DLT, dose-limiting toxicities. RP2D: recommended phase 2 dose. QD, daily; BID, two times per day; Q2W, 2 week cycle; Q3W,, 3 week cycle; Q4W, 4 week cycle.