Clinical Situation: Platinum-Sensitive Recurrence

Platinum-Sensitive (Pt-S): Treatment given for recurrence occurring 6 months or more after last platinum-based treatment

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 III Cisplatin, Carboplatin, 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*

v. 6/2017

Chemotherapy NCT00102414 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*

v. 6/2017

Chemotherapy NCT00538603 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

v. 6/2017

Standard of Care Targeted Drugs
DNA Damage Repair Pathway Inhibitors:PARP NCT01078662 II Olaparib 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%
PFS: 9.4 months

v. 9/2018

DNA Damage Repair Pathway Inhibitors:PARP Rucaparib FDA Approval Data II Rucaparib Treatment of BRCA-mutated Ovarian Cancer After 2 or More Chemotherapies

Rucaparib shows promising responses in BRCA MUT patients

ORR: 66%

v. 9/2018

Angiogenesis Inhibitors: VEGF NCT00434642 III Bevacizumab, Carboplatin, Gemcitabine 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

v. 1/2017

Angiogenesis Inhibitors: VEGF NCT00565851 III Bevacizumab, Carboplatin, Paclitaxel 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*

v. 7/2018

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 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*

v. 11/2018

Drugs in NCCN Guidelines
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

Fos+Bev vs Bev:

PFS: 7.6 vs 6.1 months

v. 4/2017

Drugs in Clinical Development
DNA Damage Repair Pathway Inhibitors:PARP 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 and PFS for olaparib+cediranib combination, particularly in patients with gBRCA WT or unknown BRCA status

Ola+Ced vs Ola:

ORR: 76 vs 32%*
PFS: 23.7 vs 5.7 months*
ORR: 83 vs 63%
PFS: 16.4 vs 16.5 months

v. 6/2017

DNA Damage Repair Pathway Inhibitors:PARP 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

v. 1/2017

DNA Damage Repair Pathway Inhibitors:PARP NCT01891344 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


ORR: 80 vs 29 vs 10%*
PFS: 12.8 vs 5.7 vs 5.2 months*

v. 4/2017

DNA Damage Repair Pathway Inhibitors:PARP NCT02354586 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

ORR: 39%
HRD-positive (incl. BRCA MUT):
ORR: 27%

v. 11/2018

DNA Damage Repair Pathway Inhibitors:PARP 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 (MEDIOLA)

Promising activity of olaparib+durvalumab combination in gBRCA MUT

ORR: 72%
DCR (3 months): 81%

v. 8/2018

Cell Cycle Inhibitors:p53 NCT02098343 II APR-246, Carboplatin, Liposomal doxorubicin PiSARRO: p53 Suppressor Activation in Recurrent High Grade Serous Ovarian Cancer, a Phase Ib/II Study of Systemic Carboplatin Combination Chemotherapy With or Without APR-246

Encouraging activity of APR-246+carboplatin+liposomal doxorubicin in TP53-mutated platinum-sensitive and partially platinum-sensitive patients

ORR: 62%
PFS: 10.5 months

v. 8/2018

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%

v. 4/2017

Immunotherapy: Antibodies/FRalpha NCT00849667 III Carboplatin, Farletuzumab, Paclitaxel A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Assess the Efficacy and Safety of Weekly MORAb-003 in Combination With Carboplatin and Taxane in Subjects With Platinum-sensitive Ovarian Cancer in First Relapse

PFS and OS benefit with addition of farletuzumab to carboplatin+paclitaxel in patients with baseline CA125 levels ≤3xULN

CarboPt+Pac+Far vs CarboPt+Pac+Placebo:

PFS: 13.6 vs 8.8 months*
OS: Not Reached vs 29.1 months*

v. 11/2017

*Statistically significant result

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