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 2.5 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

Chemotherapy GOTIC003; Intergroup study II Carboplatin, Gemcitabine, Liposomal doxorubicin A phase II randomized controlled study of pegylated liposomal doxorubicin and carboplatin vs. gemcitabine and carboplatin for platinum-sensitive recurrent ovarian cancer (GOTIC003/intergroup study)

Carboplatin with liposomal doxorubicin or gemcitabine are comparable; however, the liposomal doxorubicin combo has a more favorable risk-benefit profile than that of the gemcitabine combo

CarboPt+PLD vs CarboPt+Gem:

ORR: 57.1 vs 56.4%
PFS: 12.0 vs 9.8 months

pub 2019

Standard of Care Targeted Drugs
Angiogenesis Inhibitors: VEGF NCT00434642; OCEANS III Carboplatin, Gemcitabine, Bevacizumab 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 Carboplatin, Paclitaxel, Bevacizumab 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 Carboplatin, Gemcitabine, Liposomal doxorubicin, Bevacizumab 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 Carboplatin, Gemcitabine, Liposomal doxorubicin, Paclitaxel, Bevacizumab 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*

pub 2021

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 Fosbretabulin, Bevacizumab 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 2020

Drugs in Clinical Development
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 or OS; 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: 33.5 vs 31.0 vs 32.7 months

pub 2022, abs Oct 2023 and presentation

DNA Damage Repair Pathway Inhibitors: PARP NCT02734004; MEDIOLA I/II Bevacizumab, 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 gBRCA MUT OC patients; olaparib+durvalumab+bevacizumab shows promising activity in non-gBRCA MUT patients regardless of LOH score and mutation status of common DDR genes

Ola+Dur, gBRCA MUT:
ORR: 92.2%
DCR (7 months): 65.6%
PFS: 11.1 months

Ola+Dur, non-gBRCA MUT:
ORR: 34%
CBR: 28%
PFS: 5.5 months
OS: 26.1 months

Ola+Dur+Bev, non-gBRCA MUT:
ORR: 87%
CBR: 74%
PFS: 14.7 months
DoR: 11 months
OS: 31.9 months

abs Oct 2019, abs Sep 2020, pub 2020, abs Sep 2022, pub 2024

Antibody Drug Conjugates: FRalpha NCT02606305; FORWARD II Ib/II Carboplatin, 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 carboplatin and mirvetuximab shows encouraging activity in FRalpha+ platinum sensitive patients

ORR: 71%
PFS: 15 months

pub 2018, abs Oct 2020

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%
PFS: 13.3 months

abs Jun 2021 and presentation, Sep 2022 presentation

Angiogenesis Inhibitors: VEGF NCT02873962 II Nivolumab, Bevacizumab 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/PD-L1 NCT02891824; ATALANTE III Atezolizumab, Bevacizumab, Carboplatin, Gemcitabine, Liposomal doxorubicin, Paclitaxel A Randomized, Double-blinded, Phase III Study of Atezolizumab Versus Placebo in Patients With Late Relapse of Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer Treated by Platinum-based Chemotherapy and Bevacizumab

Atezolizumab does not improve PFS in the overall population or in the patients with PD-L1 positive tumors

PFS: 13.5 vs 11.3 months

PD-L1+:
PFS: 15.2 vs 13.1 months

pub 2023

*Statistically significant result

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