Drug Class: DNA Damage Repair Pathway Inhibitors

DNA Damage Repair Pathway Inhibitors: PARP

First-line treatment with/without extended (maintenance) treatment

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

No Prior Therapies

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

1 Prior Therapy

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

2 Prior Therapies 3 Prior Therapies Prior Therapies Not Reported

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

1 Prior Therapy 2 Prior Therapies 4 Prior Therapies 5 Prior Therapies Prior Therapies Not Reported

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

2 Prior Therapies 3 Prior Therapies 4 Prior Therapies 5 Prior Therapies Prior Therapies Not Reported

Treatment given for recurrence occurring at any time 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

Prior Therapies Not Reported

DNA Damage Repair Pathway Inhibitors: ATR

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

Prior Therapies Not Reported

DNA Damage Repair Pathway Inhibitors: PARP

First-line treatment with/without extended (maintenance) 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
NCT02470585; VELIA III Carboplatin, Paclitaxel, Veliparib A Phase 3 Placebo-Controlled Study of Carboplatin/Paclitaxel With or Without Concurrent and Continuation Maintenance Veliparib (PARP Inhibitor) in Subjects With Previously Untreated Stages III or IV High-Grade Serous Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Veliparib added to chemotherapy and continued as maintenance significantly extends PFS in all newly diagnosed patients, but shows most benefit in BRCA MUT patients

CarboPt+Pac+Vel w/Vel maint vs CarboPt+Pac+Vel vs CarboPt+Pac:

All patients:
PFS: 23.5 vs 15.2 vs 17.3 months*
BRCA MUT:
PFS: 34.7 vs 21.1 vs 22.0 months*
BRCA WT:
PFS: 18.2 vs 14.5 vs 15.1 months

pub 2019

NCT03326193; OVARIO II Bevacizumab, Carboplatin, Niraparib, Paclitaxel Phase 2, Single-arm, Open-label Study to Evaluate the Safety and Efficacy of Niraparib Combined With Bevacizumab as Maintenance Treatment in Patients With Advanced Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Following Front-line Platinum-based Chemotherapy With Bevacizumab

Niraparib + bevacizumab maintenance treatment does not appear to cause cumulative toxicities and shows promising PFS

PFS (6 months): 89.5%

abs Mar 2020

NCT00989651; GOG-9923 I Bevacizumab, Carboplatin, Cisplatin, Paclitaxel, Veliparib A Phase I Study of Intravenous Carboplatin/Paclitaxel or Intravenous and Intraperitoneal Paclitaxel/Cisplatin in Combination With Continuous or Intermittent /CTEP-Supplied Agent ABT-888 (NSC #737664) and CTEP-Supplied Agent Bevacizumab (NSC #704865) in Newly Diagnosed Patients With Previously Untreated Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Patients receiving IP cisplatin + IV/IP paclitaxel show promising PFS and OS when compared to patients receiving IV carboplatin+paclitaxel, however differences may be reflective of selection bias toward patients enrolled on the IP chemotherapy arm

IV vs weekly IV vs IP (all w/ Vel cont):

PFS: 24.5 vs 23.5 vs 43.2 months
OS: 65.2 vs 66.5 vs NR months

abs Mar 2020

*Statistically significant result

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

NCT02477644; PAOLA-1 III Bevacizumab, Carboplatin, Olaparib, Paclitaxel Prescribing Information Randomized, Double-Blind, Phase III Trial Olaparib vs. Placebo Patients With Advanced FIGO Stage IIIB-IV High Grade Serious or Endometrioid Ovarian, Fallopian Tube, or Peritoneal Cancer Treated Standard First-Line Treatment

Dual maintenance therapy with olaparib and bevacizumab significantly improves PFS compared with bevacizumab maintenance alone for BRCA MUT and HRD+ patients

Ola vs Placebo:

All patients:
PFS: 22.1 vs 16.6 months*
BRCA MUT:
PFS: 37.2 vs 21.7 months*
HRD+ (excl. BRCA MUT):
PFS: 28.1 vs 16.6 months*
HRD-:
PFS: 16.9 vs 16.0 months

abs Oct 2019

NCT02655016; PRIMA III Niraparib Prescribing Information A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Niraparib Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy

Considerably improved PFS for all patients that received niraparib maintenance treatment

Nir maint vs Placebo:

All patients:
PFS: 13.8 vs 8.2 month*
HRD+ (excl. BRCA MUT):
PFS: 19.6 vs 8.2 months*
HRD-:
PFS: 8.1 vs 5.4 months*

pub 2019

*Statistically significant result

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:
PFS: 9.3 vs 3.9 months*
gBRCA MUT:
PFS: 21.0 vs 5.5 months*
HRD-:
PFS: 6.9 vs 3.8 months*
HRD+ (excl. BRCA MUT):
PFS: 9.3 vs 3.7 months*

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 and OS with olaparib maintenance treatment in gBRCA MUT patients

Ola vs Placebo:

PFS: 19.1 vs 5.5 months*
OS: 51.7 vs 38.8 months
TFST: 27.4 vs 7.2 months*

pub 2017, abs May 2020 and presentation

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:
PFS: 13.7 vs 5.4 months*
BRCA WT/LOH low:
PFS: 8.2 vs 5.3 months*
BRCA WT/LOH high:
PFS: 11.1 vs 5.6 months*
BRCA MUT:
PFS: 26.8 vs 5.4 months*

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:
PFS: 8.4 vs 4.8 months*
OS: 29.8 vs 27.8 months*
BRCA WT:
PFS: 7.4 vs 5.5 months*
OS: 24.5 vs 26.6 months
BRCA MUT:
PFS: 11.2 vs 4.3 months*
OS: 34.9 vs 30.2 months*

pub 2012; 2014; 2016

*Statistically significant result

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 Pt-S gBRCA MUT patients

ORR: 46%
PFS: 9.4 months

pub 2016

NCT02354586; QUADRA II Niraparib Prescribing Information 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:
ORR: 39%

HRD+ (excl. BRCA MUT):
ORR: 20%

pub 2019

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 2018

Drugs in NCCN Guidelines
NCT02354131; AVANOVA 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 improvement of activity with niraparib+bevacizumab compared to niraparib alone

Nir+Bev vs Nir:

ORR: 62 vs 30%*
PFS: 12.5 vs 5.5 months*

pub 2019, abs May 2020 and poster

Drugs in Clinical Development
NCT02282020; SOLO-3 III Gemcitabine, Liposomal doxorubicin, Olaparib, Paclitaxel, Topotecan A Phase III, Open Label, Randomised, Controlled, Multi-centre Study to Assess the Efficacy and Safety of Olaparib Monotherapy Versus Physician's Choice Single Agent Chemotherapy in the Treatment of Platinum Sensitive Relapsed Ovarian Cancer in Patients Carrying Germline BRCA1/2 Mutations.

Improved ORR and PFS for gBRCA MUT patients treated with olaparib vs nonplatinum chemotherapy

Ola vs TPC:

ORR: 72 vs 51%*
PFS: 13.4 vs 9.2 months*

pub 2020

NCT02446600; NRG-GY004 III Carboplatin, Cediranib, Gemcitabine, Liposomal doxorubicin, Olaparib, Paclitaxel A Phase III Study Comparing Single-Agent Olaparib or the Combination of Cediranib and Olaparib to Standard Platinum-Based Chemotherapy in Women With Recurrent Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Cediranib+olaparib has similar activity to standard of care in relapsed platinum sensitive ovarian cancer but does not improve PFS; in gBRCA MUT patients cediranib+olaparib and olaparib alone shows substantial activity

Ola+Ced vs Ola vs Treatment of Physician's Choice (TPC):

ORR: 69.4 vs 52.4 vs 71.3%
PFS: 10.4 vs 8.2 vs 10.3 months
OS: 30.5 vs 29.2 vs 31.3 months

abs May 2020 and presentation

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:
ORR: 76 vs 32%*
PFS: 23.7 vs 5.7 months*
OS: 37.8 vs 23.0 months*

gBRCA MUT:
ORR: 83 vs 63%
PFS: 16.4 vs 16.5 months
OS: 44.2 vs 40.1 months

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%
PFS: 11.0 months

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%*
PFS: 12.8 vs 5.7 vs 5.2 months*

pub 2017

NCT02345265 II Cediranib, Olaparib A Phase 2 Study of Olaparib and Cediranib for the Treatment of Recurrent Ovarian Cancer

Olaparib+cediranib is effective independent of gBRCA status

ORR: 74.3%

abs Jun 2018

NCT02734004; MEDIOLA 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 in Pt-S gBRCA MUT ovarian cancer patients

ORR: 71.9%
DCR (7 months): 65.6%
PFS: 11.1 months

abs Oct 2019

NCT02660034 I/Ib Pamiparib, Tislelizumab A Phase 1/1b, Open Label, Multiple Dose, Dose Escalation and Expansion Study to Investigate the Safety, Pharmacokinetics and Antitumor Activity of the Anti-PD-1 Monoclonal Antibody BGB-A317 in Combination With the PARP Inhibitor BGB-290 in Subjects With Advanced Solid Tumors

Pamiparib+tislelizumab is well tolerated and associated with antitumor responses in both BRCA WT and BRCA MUT ovarian cancer

16 evaluable Pt-S:
ORR: 44%
DCR: 63%

pub 2019

*Statistically significant result

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 Pt-R gBRCA MUT patients

ORR: 30%
PFS: 5.5 months

pub 2016

NCT02354586; QUADRA II Niraparib Prescribing Information 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:
ORR: 27%

pub 2019

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 2018

Drugs in NCCN Guidelines
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 some activity in late-line treatment setting

HRD+ (incl. BRCA MUT):
ORR: 10%

HRD+ (excl. BRCA MUT):
CBR: 14%

pub 2019

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%
PFS: 5.8 months

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:
ORR: 18%

gBRCA MUT:
ORR: 60% (n=5)

abs Jun 2018

NCT02889900; CONCERTO II Cediranib, Olaparib A Single Arm, Open-label, Phase IIb Study to Assess the Efficacy and Safety of the Combination of Cediranib and Olaparib Tablets in Women With Recurrent Platinum Resistant Epithelial Ovarian Cancer, Including Fallopian Tube and/or Primary Peritoneal Cancer Who do Not Carry a Deleterious or Suspected Deleterious Germline BRCA Mutation

Olaparib+cediranib has manageable toxicity and shows evidence of anti-tumor activity in heavily pretreated platinum resistant non-gBRCA MUT patients

ORR: 15.6%
PFS: 5.1 months

abs May 2020 and poster

NCT03314740; BAROCCO II Cediranib, Olaparib The BAROCCO Study (Best Approach in Recurrent-Ovarian-Cancer-with Cediranib-Olaparib): an Italian Multicenter Randomized Phase II Study of Weekly Paclitaxel vs. Cediranib-Olaparib With Continuous Schedule vs. Cediranib-Olaparib With Intermittent Schedule in Patients With Platinum Resistant High Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer.

Olaparib+cediranib (continuous dosing) shows a promising trend towards improved PFS in comparison with weekly paclitaxel, in particular in BRCA WT patients

Ola+Ced (continuous) vs Ola+Ced (intermittent) vs Pac:

gBRCA WT:
PFS: 5.8 vs 3.8 vs 2.1 months

abs Oct 2019

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 independent of BRCA status, HRD status and PD-L1 expression

ORR: 18%

pub 2019

NCT02660034 I/Ib Pamiparib, Tislelizumab A Phase 1/1b, Open Label, Multiple Dose, Dose Escalation and Expansion Study to Investigate the Safety, Pharmacokinetics and Antitumor Activity of the Anti-PD-1 Monoclonal Antibody BGB-A317 in Combination With the PARP Inhibitor BGB-290 in Subjects With Advanced Solid Tumors

Pamiparib+tislelizumab is well tolerated and associated with antitumor responses in both BRCA WT and BRCA MUT ovarian cancer

18 evaluable Pt-R:
ORR: 22%
DCR: 50%

pub 2019

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 High Grade Serous Ovarian Cancer

Encouraging activity of olaparib+alpelisib combination in gBRCA WT patients

ORR: 36%
PFS: 7.2 months

gBRCA WT:
ORR: 35%

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
NCT02511795 Ib Adavosertib, Olaparib A Phase Ib Study of AZD1775 and Olaparib in Patients With Refractory Solid Tumours

Olaparib+adavosertib shows anti-tumor activity, particularly at the twice daily (BID) schedule

ORR: 15%
DCR: 85%

abs Apr 2019 and poster

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 in ovarian cancer

Ola+Dur:
ORR: 15%
DCR (4 months): 53%

Ced+Dur+Ola: 7 evaluable
ORR: 42.9%
DCR: 71.4%
Most patients Pt-R, BRCA WT

pub 2017; abs Oct 2018, pub 2019

NCT01286987 I Talazoparib A Phase 1, First In Human, Single-arm, Open-label Study Of Once A Day, Orally Administered Talazoparib (Bmn 673) In Patients With Advanced Or Recurrent Solid Tumors

Talazoparib shows promising activity in gBRCA MUT cancer

12 evaluable ovarian
ORR: 41.7% (1CR, 4PR)
CBR: 66.7% (1CR, 4PR, 3SD)
PFS: 9.1 months

pub 2017

DNA Damage Repair Pathway Inhibitors: ATR

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
Drugs in Clinical Development
NCT02595892 II Berzosertib, Gemcitabine Phase 2 Study of M6620 (VX-970) in Combination With Gemcitabine Versus Gemcitabine Alone in Subjects With Platinum-Resistant Recurrent Ovarian or Primary Peritoneal Fallopian Tube Cancer

Addition of berzosertib to gemcitabine increased PFS without additional toxicity

Ber+Gem vs Gem:

PFS: 5.7 vs 3.7 months*

abs Oct 2019

*Statistically significant result

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