Clinical Situation: Maintenance After First-line Treatment

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

First-line treatment with/without extended (maintenance) 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 Targeted Drugs
Angiogenesis Inhibitors: VEGF NCT00262847; GOG-218 III Bevacizumab, Carboplatin, Paclitaxel Prescribing Information A Phase III Trial of Carboplatin and Paclitaxel Plus Placebo Versus Carboplatin and Paclitaxel Plus Concurrent Bevacizumab (NSC # 704865) Followed by Placebo, Versus Carboplatin and Paclitaxel Plus Concurrent and Extended Bevacizumab, in Women With Newly Diagnosed, Previously Untreated, Stage III or IV Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer (GOG218)

Improved PFS, but no OS difference with addition of bevacizumab to carboplatin+paclitaxel; potential benefit for patients with stage IV disease

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

All:
PFS: 14.1 vs 11.2 vs 10.3 months*
OS: 43.4 vs 40.8 vs 41.1 months

Stage IV patients:
OS: 42.8 vs 34.5 vs 32.6 months

pub 2019

Angiogenesis Inhibitors: VEGF NCT00483782; ICON7 III Bevacizumab, Carboplatin, Paclitaxel ICON7 - A Randomised, Two-Arm, Multi-Centre Gynaecologic Cancer InterGroup Trial of Adding Bevacizumab to Standard Chemotherapy (Carboplatin and Paclitaxel) in Patients With Epithelial Ovarian Cancer

Improved PFS and OS with addition of bevacizumab to carboplatin+paclitaxel in high risk patients

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

All:
PFS: 19.9 vs 17.5 months
OS: 45.5 vs 44.6 months (restricted mean survival)
High risk:
PFS: 16.0 vs 10.5 months*
OS: 39.3 vs 34.5 months* (restricted mean survival)

pub 2011; 2015

Drugs in Clinical Development
DNA Damage Repair Pathway Inhibitors: PARP 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

DNA Damage Repair Pathway Inhibitors: PARP 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): 90%
PFS (12 months): 75%
PFS (18 months) 62%

abs Mar 2020, abs Mar 2021

DNA Damage Repair Pathway Inhibitors: PARP 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

pub 2020, abs Mar 2020

Angiogenesis Inhibitors: VEGF NCT00951496; GOG-252 III Bevacizumab, Carboplatin, Cisplatin, Paclitaxel A Phase III Clinical Trial of Bevacizumab With IV Versus IP Chemotherapy in Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma

Compared to the IV reference arm, PFS was not significantly increased with either IP regimen

IV CarboPt+Pac+Bev w/ Bev maint vs IP CarboPt+Pac+Bev w/ Bev maint vs IP CisPt+Pac+Bev w/ Bev maint:

PFS: 24.9 vs 27.4 vs 26.2 months
OS: 75.5 vs 78.9 vs 72.9 months

pub 2019

Immunotherapy: Checkpoint Inhibitors/PD-1 NCT02766582 II Carboplatin, Paclitaxel, Pembrolizumab Phase II Open Label Nonrandomized Trial of the Anti PD 1 Therapy Pembrolizumab With First Line Platinum Based Chemotherapy Followed by 12 Months Pembrolizumab Monotherapy for Patients With Stage III/IV Epithelial Ovarian Cancer

Pembrolizumab with carboplatin+paclitaxel on a weekly schedule is overall well tolerated and 12 months PFS is promising

28 patients
PFS (6 months): 82%
PFS (9 months): 77%
PFS (12 months): 59%

abs Mar 2020

Immunotherapy: Checkpoint Inhibitors/PD-L1 NCT02718417; JAVELIN Ovarian 100 III Avelumab, Carboplatin, Paclitaxel A Randomized, Open-Label, Multicenter, Phase 3 Study To Evaluate The Efficacy And Safety Of Avelumab (MSB0010718C) In Combination With And/Or Following Chemotherapy In Patients With Previously Untreated Epithelial Ovarian Cancer Javelin Ovarian 100

Avelumab addition to carboplatin+paclitaxel and/or continued as maintenance therapy for newly diagnosed ovarian cancer patients does not improve PFS; PD-L1, CD8, and gBRCA1/2 status did not predict differential clinical benefit 

CarboPt+Pac+Ave+Ave maint vs CarboPt+Pac+Ave maint vs CarboPt+Pac:

ORR: 36.0 vs 30.4 vs 30.4%
PFS: 18.1 vs 16.8 vs NR months

pub 2021

Immunotherapy: Checkpoint Inhibitors/PD-L1 NCT03038100; IMagyn050 III Atezolizumab, Bevacizumab, Carboplatin, Paclitaxel A Phase III, Multicenter, Randomized, Study of Atezolizumab Versus Placebo Administered in Combination With Paclitaxel, Carboplatin, and Bevacizumab to Patients With Newly-Diagnosed Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Atezolizumab does not significantly improve PFS in the ITT or PD-L1+ population. The combination is generally well tolerated with manageable AEs; neither BRCA MUT nor HRD+ was associated with greater clinical benefit from adding atezolizumab

CarboPt+Tax+Bev+Ate vs CarboPt+Tax+Bev+Placebo:
PFS: 19.5 vs 18.4 months

PD-L1+ patients:
PFS: 20.8 vs 18.5 months

pub 2021

Immunotherapy: Antibodies/MUC16 (CA125) NCT01616303 II Carboplatin, Oregovomab, Paclitaxel Phase 2: A Randomized Controlled Study on Effectiveness of Chemotherapy (Carboplatin-Paclitaxel) Versus Chemo-immunotherapy (Carboplatin-Paclitaxel-Oregovomab) in Patients With Advanced Epithelial Ovarian, Adnexal or Peritoneal Carcinoma

Addition of oregovomab to carboplatin+paclitaxel and continued as maintenance treatment significantly increases PFS and OS

CarboPt+Pac+Ore vs CarboPt+Pac:

PFS: 41.8 vs 12.2 months*
OS: NR vs 43.2 months*

pub 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.

Drug Class Trial ID # Phase Drugs Clinical Trial Title Key Conclusion and Results
Standard of Care Targeted Drugs
DNA Damage Repair Pathway Inhibitors: PARP 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; the benefit derived from 2 years of maintenance olaparib is sustained beyond the end of treatment

Ola maint vs Placebo:

PFS: 56.0 vs 13.8 months*
PFS (5 years): 48 vs 21%

pub 2018, abs Sep 2020, abs Mar 2021, pub 2021

DNA Damage Repair Pathway Inhibitors: PARP 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 and PFS2 compared with bevacizumab maintenance alone for BRCA MUT and HRD+ patients

Ola vs Placebo:

All patients:
PFS: 22.1 vs 16.6 months*
PFS2: 36.5 vs 32. 6 months*
BRCA MUT:
PFS: 37.2 vs 21.7 months*
PFS2: NR vs 45.0 months*
HRD+ (excl. BRCA MUT):
PFS: 28.1 vs 16.6 months*
PFS2: 50.3 vs 30.1 months*
HRD-:
PFS: 16.9 vs 16.0 months
PFS2: 24.4 vs 26.4 months

abs Oct 2019, abs Sep 2020

DNA Damage Repair Pathway Inhibitors: PARP 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, poster Mar 2021

Drugs in NCCN Guidelines
Hormonal Therapy: Anti-Estrogens Retrospective Study: Hormonal Maintenance in LGSC II Anastrozole, Letrozole, Tamoxifen Retrospective analysis of Hormonal Maintenance Therapy for Patients With LGS Ovarian Cancer

Significantly longer PFS with hormonal maintenance therapy (HMT) vs. observation (OBS) in Low Grade Serous OC patients

HMT vs OBS:

PFS: 64.9 vs 26.4 months*
OS: 115.7 vs 102.7 months

pub 2017

Drugs in Clinical Development
Hormonal Therapy: Aromatase Letrozole University Hospital Basel Single-site Letrozole Letrozole may be a valuable maintenance treatment in high-grade serous ovarian cancer patients

Promising activity with minimal toxicity of letrozole maintenance in ER-positive patients

Let vs Placebo:

All patients:
RFS: Not Reached vs 13.2 months*

Patients w/o residual disease:
RFS: Not Reached vs 20.8 months

Patients w/ residual disease:
RFS: 21.6 (n=7) vs 8.8 (n=6) months*

pub 2018

Immunotherapy: Vaccine/TGFbeta NCT01309230 II Gemogenovatucel-T Open Label Phase II Trial of Adjuvant Bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Vaccine (FANG™) for High Risk Stage III/IV Ovarian Cancer

FANG vaccine shows encouraging anti-tumor activity and increased RFS with remarkable safety

FANG vs Placebo:

RFS (from time of procurement, mean/median):
27.5/20.1 (n=31) vs 16.0/12.6 (n=11) months

pub 2016

Immunotherapy: Vaccine/TGFbeta NCT02346747; VITAL II Gemogenovatucel-T A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial of Vigil Engineered Autologous Tumor Cell Immunotherapy in Subjects With Stage IIIb-IV Ovarian Cancer in Clinical Complete Response Following Surgery and Primary Chemotherapy

Vigil immunotherapy as maintenance after first-line therapy in stage III–IV ovarian cancer is well tolerated and shows clinical benefit, particularly for BRCA WT and HRP patients

VIGIL vs Placebo:
RFS (from time of randomization): 11.5 vs 8.4 months

BRCA WT patients:
VIGIL vs Placebo:
RFS (from time of randomization): 12.7 vs 8.0 months*
OS: NR vs 41.4 months*

HRP patients:
VIGIL vs Placebo:
RFS (from time of randomization): 10.6 vs 5.7 months*
OS: NR vs 26.9 months*

pub 2020, pub 2021

*Statistically significant result

< Return to Clinical Situation

< Return to Clinical Trial Results Homepage