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

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

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): 89.5%

abs Mar 2020

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

abs Mar 2020

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 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

Ola maint vs Placebo:

PFS: Not Reached vs 14.1 months*

pub 2018

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 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

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

Drugs in NCCN Guidelines
Chemotherapy NCT00003120; GOG-178 III Paclitaxel Phase III Randomized Trial of 12 Months vs. 3 Months of Paclitaxel in Patients With Advanced Ovarian Cancer Who Attain a Clinically Defined Complete Response (CR) Following Platinum/Paclitaxel-Based Chemotherapy (GOG-178)

Improved PFS with 12 cycles of paclitaxel, no OS difference

12 cycles Pac vs 3 cycles Pac:

PFS: 28 vs 21 months*
OS: 53 vs 48 months

pub 2003; 2009

Hormonal Therapy: Aromatase 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
Chemotherapy NCT00108745 III Paclitaxel, Paclitaxel Poliglumex A Randomized Phase III Trial of Maintenance Chemotherapy Comparing 12, Monthly Cycles of Single Agent Paclitaxel or CT-2103 Versus No Treatment Until Documented Relapse in Women With Advanced Ovarian, Primary Peritoneal or Fallopian Tube Cancer Who Achieve a Complete Clinical Response to Primary Platinum/Taxane Chemotherapy

Improved PFS with paclitaxel poliglumex or paclitaxel maintenance treatment, but no OS difference

Pac Poliglu vs Pac vs Placebo:

PFS: 16.3 vs 18.9 vs 13.4 months*
OS: 60 vs 51.3 vs 54.8 months

abs Mar 2017

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 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 RFS clinical benefit, particularly for BRCA WT patients

91 patients
VIGIL vs Placebo:
RFS (from time of randomization): HR: 0.69

48 BRCA WT patients:
VIGIL vs Placebo:
RFS (from time of randomization): 19.4 vs 8 months
RFS (from time of surgery/procurement): NR vs 14.8 months

abs Mar 2020

*Statistically significant result

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