Table 1 FDA-approved DDR inhibitors in ovarian cancers in the past 5 years (2016–2021)
PARP inhibitors | Trial number | Disease setting | FDA approval | Approved mutation status | Study phase | Approved year |
|---|---|---|---|---|---|---|
Olaparib | NCT01874353 | Recurrent BRCA1/2-mutant ovarian cancer with PR or CR to most recent line of platinum-based chemotherapy (after ≥ 2 lines of chemotherapy) | Maintenance therapy for patients with advanced stage ovarian cancer in CR or PR after platinum-based chemotherapy | Irrespective of BRCA1/2 status | III | 2017 |
NCT00753545 | Recurrent ovarian cancer with a PR or CR to most recent line of platinum-based chemotherapy (after ≥ 2 lines chemotherapy) | Maintenance therapy in women with advanced stage ovarian cancer in CR or PR after platinum-based chemotherapy | Irrespective of BRCA1/2 status | II | 2017 | |
NCT01844986 | Newly diagnosed, stage III-IV ovarian cancer with BRCA mutation | First-line maintenance treatment of adult patients with stage III-IV ovarian, cancer who are in CR or PR to first-line platinum-based chemotherapy | Deleterious or suspected deleterious g/sBRCA-mutations | III | 2018 | |
NCT02477644, NCT03737643 | Newly diagnosed, stage III-IV OC (other histologies if gBRCAm) with CR or PR to standard platinum based chemotherapy given with bevacizumab | First-line maintenance treatment of patients with stage III-IV epithelial OC CR or PR to chemotherapy plus bevacizumab combination | G/sBRCA1/2 and/or genomic instability | III | 2020 | |
Rucaparib | NCT01891344 | BRCA1/2-mutant, BRCA1/2-wild-type and LOH-high, or BRCA1/2-wildtype and LOH-low recurrent ovarian cancer | Advanced ovarian cancer refractory to ≥ 2 prior lines of treatment | BRCA1/2mutations | II | 2016 |
NCT01482715 | Phase I: advanced stage ovarian cancer Phase II: germline BRCA1/2-mutant ovarian cancer | Ovarian cancer refractory to ≥ 2 prior lines of treatment | BRCA1/2mutations | I/II | 2016 | |
NCT01968213 | Recurrent ovarian cancer with PR or CR to most recent line of platinum-based chemotherapy (after ≥ 2 lines chemotherapy | Maintenance therapy for patients with advanced-stage ovarian cancer in CR or PR after platinum-based chemotherapy | Irrespective of BRCA1/2 status | III | 2018 | |
Niraparib | NCT01847274 | Platinum-sensitive, recurrent ovarian cancer stratified into two subgroups: germline BRCA1/2 mutant and BRCA1/2 wild type (after ≥ 2 lines chemotherapy | Maintenance therapy for patients with advanced stage ovarian cancer who are in CR or PR after platinum-based chemotherapy | – | III | 2017 |