Clinical Situation: Platinum-Sensitive Recurrence

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-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.

Drug Class Trial ID # Phase Drugs Clinical Trial Title Key Conclusion and Results
Standard of Care Chemotherapy
Chemotherapy NCT00002894; ICON4 III Carboplatin, Cisplatin, Paclitaxel A Randomized Trial of Paclitaxel (Taxol) in Combination With Platinum Chemotherapy vs. Conventional Platinum-Based Chemotherapy in the Treatment of Women With Relapsed Ovarian Cancer (ICON4)

Improved PFS and OS with addition of paclitaxel to platinum

CisPt/CarboPt+Pac vs CisPt/CarboPt:

ORR: 66 vs 54%
PFS: 12 vs 9 months*
OS: 29 vs 24 months*

pub 2003

Chemotherapy NCT00102414; NCIC OV15 III Carboplatin, Gemcitabine A Randomized Phase III Study Comparing Gemcitabine Plus Carboplatin Versus Carboplatin Monotherapy in Patients With Advanced Epithelial Ovarian Carcinoma Who Failed First-Line Platinum-Based Therapy (NCIC OV15)

Improved PFS with addition of gemcitabine to carboplatin

CarboPt+Gem vs. CarboPt:

ORR: 47.2 vs 30.9%*
PFS: 8.6 vs. 5.8 months*

pub 2006

Chemotherapy NCT00538603; CALYPSO III Carboplatin, Liposomal doxorubicin, Paclitaxel Multi-national, Randomized, Phase III, GCIG Intergroup Study Comparing Pegylated Liposomal Doxorubicin (CAELYX) and Carboplatin vs. Paclitaxel and Carboplatin in Patients With Epithelial Ovarian Cancer in Late Relapse. (CALYPSO)

Carboplatin+liposomal doxorubicin has similar PFS and OS to carboplatin+paclitaxel with less sensory neuropathy

CarboPt+PLD vs CarboPt+Pac:

PFS: 11.3 vs 9.4 months*
OS: 30.7 vs 33.0 months

pub 2012

Standard of Care Targeted Drugs
Angiogenesis Inhibitors: VEGF NCT00434642; OCEANS III Bevacizumab, Carboplatin, Gemcitabine Prescribing Information A Phase III, Multicenter, Randomized, Blinded, Placebo-controlled Trial of Carboplatin and Gemcitabine Plus Bevacizumab in Patients With Platinum-sensitive Recurrent Ovary, Primary Peritoneal, or Fallopian Tube Carcinoma (OCEANS)

Improved ORR and PFS with addition of bevacizumab to carboplatin and gemcitabine, but no OS difference

CarboPt+Gem+Bev vs CarboPt+Gem+Placebo:

ORR: 78.5 vs 57.4%*
PFS: 12.4 vs 8.4 months*
OS: 33.6 vs 32.9 months

pub 2012; 2015

Angiogenesis Inhibitors: VEGF NCT00565851; GOG-213 III Bevacizumab, Carboplatin, Paclitaxel Prescribing Information A Phase III Randomized Controlled Clinical Trial of Carboplatin and Paclitaxel (or Gemcitabine) Alone or in Combination With Bevacizumab (NSC #704865) Followed by Bevacizumab and Secondary Cytoreductive Surgery in Platinum-Sensitive, Recurrent Ovarian, Peritoneal Primary and Fallopian Tube Cancer. NCI-Supplied Agents: Bevacizumab (NSC #704865) (GOG 0213)

Improved ORR, PFS and OS with the addition of bevacizumab to carboplatin+paclitaxel

CarboPt+Pac+Bev vs CarboPt+Pac:

ORR: 78 vs 59%*
PFS: 13.8 vs 10.4 months*
OS: 42.2 vs 37.3 months*

pub 2017

Angiogenesis Inhibitors: VEGF NCT01837251 III Bevacizumab, Carboplatin, Gemcitabine, Liposomal doxorubicin A Prospective Randomized Phase III Trial of Carboplatin/Gemcitabine/Bevacizumab vs. Carboplatin/Pegylated Liposomal Doxorubicin/Bevacizumab in Patients With Platinum-sensitive Recurrent Ovarian Cancer

Improved PFS and OS with addition of liposomal doxorubicin to carboplatin+bevacizumab compared to gemcitabine

CarboPt+Gem+Bev vs CarboPt+PLD+Bev:

PFS: 11.7 vs 13.3 months*
OS: 27.8 vs 31.9 months*

pub 2020

Angiogenesis Inhibitors: VEGF NCT01802749; MITO16B-MaNGO OV2B III Bevacizumab, Carboplatin, Gemcitabine, Liposomal doxorubicin, Paclitaxel Multicenter Phase III Randomized Study With Second Line Chemotherapy Plus or Minus Bevacizumab in Patients With Platinum Sensitive Epithelial Ovarian Cancer Recurrence After a Bevacizumab/Chemotherapy First Line

Rechallenge with bevacizumab in combination with platinum-based doublets is associated with a significantly prolonged PFS

CarboPt+Pac+Bev vs CarboPt+Pac:

ORR: 74.6 vs 65.7%
PFS: 11.8 vs 8.8 months*

abs Jun 2018

DNA Damage Repair Pathway Inhibitors: PARP 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

DNA Damage Repair Pathway Inhibitors: PARP 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

DNA Damage Repair Pathway Inhibitors: PARP 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
DNA Damage Repair Pathway Inhibitors: PARP 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

Angiogenesis Inhibitors: VEGF NCT01305213 II Bevacizumab, Fosbretabulin A Randomized Phase II Evaluation of Single-Agent Bevacizumab (NSC #704865) and Combination Bevacizumab With Fosbretabulin Tromethamine (CA4P) (NSC #752293) in the Treatment of Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma

Improved PFS with addition of fosbretabulin to bevacizumab

Bev+Fos vs Bev:

PFS: 7.6 vs 6.1 months

pub 2016

Drugs in Clinical Development
DNA Damage Repair Pathway Inhibitors: PARP 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

DNA Damage Repair Pathway Inhibitors: PARP 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

DNA Damage Repair Pathway Inhibitors: PARP 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

DNA Damage Repair Pathway Inhibitors: PARP 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

DNA Damage Repair Pathway Inhibitors: PARP 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

Antibody Drug Conjugates: FRalpha NCT02606305; FORWARD II-2 Ib/II Bevacizumab, Mirvetuximab Soravtansine A Phase 1b/2 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Mirvetuximab Soravtansine (IMGN853) in Combination With Bevacizumab, Carboplatin, Pegylated Liposomal Doxorubicin, Pembrolizumab, or Bevacizumab+Carboplatin in Adults With Folate Receptor Alpha Positive Advanced Epithelial Ovarian Cancer, Primary Peritoneal Cancer or Fallopian Tube Cancer

The combination of mirvetuximab soravtansine with bevacizumab demonstrates an encouraging ORR in platinum sensitive patients with high FRalpha expression

ORR: 69%

abs May 2020 and presentation

Angiogenesis Inhibitors: VEGF NCT02873962 II Bevacizumab, Nivolumab A Phase II Study With a Safety lead-in of Nivolumab in Combination With Bevacizumab or in Combination With Bevacizumab and Rucaparib for the Treatment of Relapsed Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer

Encouraging activity of bevacizumab+nivolumab combination in Pt-S patients

ORR: 40%
CBR: 70%
PFS: 12.1 months

pub 2019

Immunotherapy: Checkpoint Inhibitors/CTLA-4 NCT01611558 II Ipilimumab A Phase II Safety and Efficacy Study of Ipilimumab Monotherapy in Recurrent Platinum Sensitive Ovarian Cancer Subjects

Ipilimumab shows encouraging anti-tumor activity, but with serious side effects

ORR: 10.3%

pub 2017

Immunotherapy: Vaccine/TAA NCT02107950 II Carboplatin, DCVAC/OvCa, Gemcitabine A Randomized, Open-label, Parallel Group, Multi-center Phase II Clinical Trial DCVAC/OvCa Added to Standard Chemotherapy in Women With Relapsed Platinum Sensitive Epithelial Ovarian Carcinoma

Significantly prolonged OS with addition of DCVAC/OvCa to carboplatin+gemcitabine

Carbo+Gem+DCVAC/OvCa vs Carbo+Gem:

PFS: 11.3 vs 10.1 months
OS: 35.5 vs. 22.1 months*

abs Mar 2019

*Statistically significant result

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