DNA Damage Repair Pathway Inhibitors: PARP
Maintenance after first-line therapy: Treatment to prevent relapse after complete response to therapy
Progression Free Survival (months)
Median length of time before the cancer comes back or gets worse
Overall Survival (months)
The length of time where half the patients in the study are still alive
Maintenance after therapy for recurrence: Treatment to control disease after complete or partial response to therapy
Progression Free Survival (months)
Median length of time before the cancer comes back or gets worse
Overall Survival (months)
The length of time where half the patients in the study are still alive
Platinum-Sensitive (Pt-S): Treatment given for recurrence occurring 6 months or more after last platinum-based treatment
Objective Response Rate (%)
Percentage of patients whose tumors shrink or go away after treatment
Progression Free Survival (months)
Median length of time before the cancer comes back or gets worse
Platinum-Resistant/Refractory (Pt-R/Rf): Treatment given for recurrence occurring less than 6 months after last platinum-based treatment or for progression during last platinum-based treatment
Objective Response Rate (%)
Percentage of patients whose tumors shrink or go away after treatment
Progression Free Survival (months)
Median length of time before the cancer comes back or gets worse
DNA Damage Repair Pathway Inhibitors: PARP
Maintenance after first-line therapy: Treatment to prevent relapse after complete response to therapy
For more detailed information, please click on the clinical trial ID number.
| Trial ID # | Phase | Drugs | Clinical Trial Title | Key Conclusion and Results |
|---|---|---|---|---|
| Standard of Care Targeted Drugs | ||||
| NCT01844986; SOLO-1 | III | Olaparib Prescribing Information | A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Advanced (FIGO Stage III-IV) Ovarian Cancer Following First Line Platinum Based Chemotherapy (SOLO-1) | Considerably improved PFS for BRCA MUT patients with olaparib maintenance treatment Ola maint vs Placebo: PFS: Not Reached vs 14.1 months* pub 2018 |
Maintenance after therapy for recurrence: Treatment to control disease after complete or partial response to therapy
For more detailed information, please click on the clinical trial ID number.
| Trial ID # | Phase | Drugs | Clinical Trial Title | Key Conclusion and Results |
|---|---|---|---|---|
| Standard of Care Targeted Drugs | ||||
| NCT01847274; NOVA | III | Niraparib Prescribing Information | A Phase 3 Randomized Double-blind Trial of Maintenance With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer (NOVA) | Improved PFS for all patients with niraparib maintenance with greatest activity in BRCA MUT patients Nir vs Placebo: non-gBRCA MUT: pub 2016 |
| NCT01874353; SOLO-2 | III | Olaparib Prescribing Information | Phase III Randomised, Double Blind, Placebo Controlled Study of Olaparib Maintenance Monotherapy in Platinum Sensitive Relapsed BRCA Mutated Ovarian Cancer Patients With a Complete or Partial Response Following Platinum Based Chemotherapy (SOLO-2) | Improved PFS with olaparib (tablets) maintenance treatment in gBRCA MUT patients Ola vs Placebo: PFS: 30.2 vs 5.5 months* pub 2017 |
| NCT01968213; ARIEL3 | III | Rucaparib Prescribing Information | Phase 3 Study of Rucaparib as Switch Maintenance After Platinum in Relapsed High Grade Serous and Endometrioid Ovarian Cancer (ARIEL3) | Improved PFS for all patients with rucaparib maintenance irrespective of number of prior therapies, but most active in BRCA MUT Ruc vs Placebo: All: pub 2017 |
| NCT00753545; Study 19 | II | Olaparib Prescribing Information | Phase II Randomised, Double Blind, Multicentre Study to Assess the Efficacy of AZD2281 in the Treatment of Patients With Platinum Sensitive Relapsed Serous Ovarian Cancer Following Treatment With Two or More Platinum Containing Regimens (Study 19) | Improved PFS and OS with olaparib maintenance Ola vs Placebo: All: pub 2012; 2014; 2016 |
Platinum-Sensitive (Pt-S): Treatment given for recurrence occurring 6 months or more after last platinum-based treatment
For more detailed information, please click on the clinical trial ID number.
| Trial ID # | Phase | Drugs | Clinical Trial Title | Key Conclusion and Results |
|---|---|---|---|---|
| Standard of Care Targeted Drugs | ||||
| NCT01078662; Study 42 | II | Olaparib Prescribing Information | A Phase II, Open Label, Non Randomised, Non Comparative, Multicentre Study to Assess the Efficacy and Safety of Olaparib Given Orally Twice Daily in Patients With Advanced Cancers Who Have a Confirmed Genetic BRCA 1 and/or BRCA2 Mutation (Study 42) | Olaparib shows promising responses in heavily pretreated gBRCA MUT patients ORR: 46% pub 2016 |
| Rucaparib FDA Approval Data | II | Rucaparib Prescribing Information | Treatment of BRCA-mutated Ovarian Cancer After 2 or More Chemotherapies | Rucaparib shows promising responses in BRCA MUT patients ORR: 66% pub Apr 2018 |
| Drugs in Clinical Development | ||||
| NCT01116648 | II | Cediranib, Olaparib | Phase I/II Study of Cediranib and Olaparib in Combination for Treatment of Recurrent Papillary-Serous Ovarian, Fallopian Tube, or Peritoneal Cancer or for Treatment of Recurrent Triple-Negative Breast Cancer | Improved ORR, PFS and OS for olaparib+cediranib combination in patients with gBRCA WT or unknown BRCA status Ola+Ced vs Ola: gBRCA WT or UNK: pub 2014; 2019 |
| NCT01540565 | II | Veliparib | A Phase II Evaluation of the Poly (ADP-Ribose) Polymerase (PARP)-1 and -2 Inhibitor Veliparib (ABT-888) (NSC#737664) in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients Who Carry a Germline BRCA1 or BRCA2 Mutation | Veliparib shows encouraging activity in gBRCA MUT cancer ORR: 35% pub 2015 |
| NCT01891344; ARIEL2 Part1 | II | Rucaparib | A Phase 2, Open-Label Study of Rucaparib in Patients With Platinum-Sensitive, Relapsed, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARIEL2 Part1) | Improved ORR and PFS with rucaparib treatment in BRCA MUT patients BRCA MUT vs BRCA WT LOH high vs BRCA WT LOH low: ORR: 80 vs 29 vs 10%* pub 2017 |
| NCT02345265 | II | Cediranib, Olaparib | A Phase 2 Study of Olaparib and Cediranib for the Treatment of Recurrent Ovarian Cancer | Olaparib+cediranib combination is effective in Pt-S patients independent of gBRCA status ORR: 74.3% abs Jun 2018 |
| NCT02354131 | II | Bevacizumab, Niraparib | Part 1: AVANOVA1 - A Phase I Study to Evaluate the Safety and Tolerability of Bevacizumab-niraparib Combination Therapy and Determine the Recommended Phase 2 Dose (RP2D) in Women With Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer Part 2: AVANOVA2 - A Two-arm, Open-label, Phase II Randomized Study to Evaluate the Efficacy of Niraparib Versus Niraparib-bevacizumab Combination in Women With Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer. | Promising activity of niraparib + bevacizumab combination Results from Phase I: ORR: 41.6% (n=12) abs Jun 2016 |
| NCT02354586; QUADRA | II | Niraparib | A Phase 2, Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of Niraparib in Patients With Advanced, Relapsed, High-Grade Serous Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Who Have Received Three or Four Previous Chemotherapy Regimens (QUADRA) | Niraparib shows promising activity in late-line treatment setting BRCA MUT: abs Jun 2018; Oct 2018 |
| NCT02734004 | I/II | Durvalumab, Olaparib | A Phase I/II Study of MEDI4736 (Anti-PD-L1 Antibody) in Combination With Olaparib (PARP Inhibitor) in Patients With Advanced Solid Tumors | Promising activity of olaparib+durvalumab combination in gBRCA MUT ORR: 72% abs Mar 2018 |
Platinum-Resistant/Refractory (Pt-R/Rf): Treatment given for recurrence occurring less than 6 months after last platinum-based treatment or for progression during last platinum-based treatment
For more detailed information, please click on the clinical trial ID number.
| Trial ID # | Phase | Drugs | Clinical Trial Title | Key Conclusion and Results |
|---|---|---|---|---|
| Standard of Care Targeted Drugs | ||||
| NCT01078662; Study 42 | II | Olaparib Prescribing Information | A Phase II, Open Label, Non Randomised, Non Comparative, Multicentre Study to Assess the Efficacy and Safety of Olaparib Given Orally Twice Daily in Patients With Advanced Cancers Who Have a Confirmed Genetic BRCA 1 and/or BRCA2 Mutation (Study 42) | Olaparib shows promising responses in heavily pretreated gBRCA MUT patients ORR: 30% pub 2016 |
| Rucaparib FDA Approval Data | II | Rucaparib Prescribing Information | Treatment of BRCA-mutated Ovarian Cancer After 2 or More Chemotherapies | Rucaparib shows promising responses in BRCA MUT patients ORR: 25% pub Apr 2018 |
| Drugs in Clinical Development | ||||
| NCT01540565 | II | Veliparib | A Phase II Evaluation of the Poly (ADP-Ribose) Polymerase (PARP)-1 and -2 Inhibitor Veliparib (ABT-888) (NSC#737664) in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients Who Carry a Germline BRCA1 or BRCA2 Mutation | Veliparib shows encouraging activity in gBRCA MUT cancer ORR: 20% pub 2015 |
| NCT02345265 | II | Cediranib, Olaparib | A Phase 2 Study of Olaparib and Cediranib for the Treatment of Recurrent Ovarian Cancer | Olaparib+cediranib combination shows activity in Pt-R patients ORR: 20% gBRCA WT: abs Jun 2018 |
| NCT02354586; QUADRA | II | Niraparib | A Phase 2, Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of Niraparib in Patients With Advanced, Relapsed, High-Grade Serous Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Who Have Received Three or Four Previous Chemotherapy Regimens (QUADRA) | Niraparib shows promising activity in late-line treatment setting BRCA MUT: abs Jun 2018; Oct 2018 |
| NCT02657889; TOPACIO | I/II | Niraparib, Pembrolizumab | Phase 1/2 Clinical Study of Niraparib in Combination With Pembrolizumab (MK-3475) in Patients With Advanced or Metastatic Triple-Negative Breast Cancer and in Patients With Recurrent Ovarian Cancer (TOPACIO) | Promising activity of niraparib + pembrolizumab combination in Pt-R/Pt-Rf patients independent of BRCA status, HRD status and PD-L1 expression ORR: 25% Pt-R/Pt-Rf and BRCA WT: abs Jun 2018 |
| NCT01623349 | I | Alpelisib, Olaparib | Phase I Study of the Oral PI3kinase Inhibitor BKM120 or BYL719 and the Oral PARP Inhibitor Olaparib in Patients With Recurrent Triple Negative Breast Cancer or Recurrent High Grade Serous Ovarian Cancer | Encouraging activity of olaparib+alpelisib combination in gBRCA WT patients ORR: 36% gBRCA WT: pub 2019 |
Treatment given for recurrence occurring at any time after last platinum-based treatment
For more detailed information, please click on the clinical trial ID number.
| Trial ID # | Phase | Drugs | Clinical Trial Title | Key Conclusion and Results |
|---|---|---|---|---|
| Drugs in Clinical Development | ||||
| NCT02484404 | I/II | Cediranib, Durvalumab, Olaparib | Phase I/II Study of the Anti-Programmed Death Ligand-1 Antibody MEDI4736 in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Cancers | Promising response rates for olaparib, cediranib and durvalumab combinations independent of PD-L1 levels Ola+Dur: Phase I: pub 2017; abs Sep 2017; Oct 2018 |
| NCT01286987 | I | Talazoparib | A Phase 1, First in Human, Single-arm, Open-label Study of Once a Day, Orally Administered Talazoparib in Patients With Advanced or Recurrent Solid Tumors | Talazoparib shows promising activity in gBRCA MUT cancer ORR: 41.7% (n=12) pub 2017 |