Clinical Situation: Maintenance After Recurrence Treatment

Maintenance after therapy for recurrence: Treatment to control disease after complete or partial response to platinum-based therapy

Maintenance after therapy for recurrence: Treatment to control disease after complete or partial 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 NCT01847274 III Niraparib A Phase 3 Randomized Double-blind Trial of Maintenance With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer (NOVA)

Improved PFS for all patients with niraparib maintenance with greatest activity in BRCA MUT patients

Nir vs Placebo:

non-gBRCA MUT:
PFS: 9.3 vs 3.9 months*
gBRCA MUT:
PFS: 21.0 vs 5.5 months*
HRD-neg:
PFS: 6.9 vs 3.8 months*
HRD-pos (BRCA WT):
PFS: 9.3 vs 3.7 months*

v. 11/2017
DNA Damage Repair Pathway Inhibitors:PARP NCT01874353 III Olaparib Phase III Randomised, Double Blind, Placebo Controlled Study of Olaparib Maintenance Monotherapy in Platinum Sensitive Relapsed BRCA Mutated Ovarian Cancer Patients With a Complete or Partial Response Following Platinum Based Chemotherapy (SOLO-2)

Improved PFS with olaparib (tablets) maintenance treatment in gBRCA MUT patients

Ola vs Placebo:

PFS: 19.1 vs 5.5 months*

v. 10/2017
DNA Damage Repair Pathway Inhibitors:PARP NCT01968213 III Rucaparib Phase 3 Study of Rucaparib as Switch Maintenance After Platinum in Relapsed High Grade Serous and Endometrioid Ovarian Cancer (ARIEL3)

Improved PFS for all patients with rucaparib maintenance irrespective of number of prior therapies, but most active in BRCA MUT

Ruc vs Placebo:

All:
PFS: 10.8 vs 5.4 months*
BRCA WT/LOH low:
PFS: 6.7 vs 5.4 months*
BRCA WT/LOH high:
PFS: 9.7 vs 5.4 months*
BRCA MUT:
PFS: 16.6 vs 5.4 months*

v. 11/2018
DNA Damage Repair Pathway Inhibitors:PARP NCT00753545 II Olaparib Phase II Randomised, Double Blind, Multicentre Study to Assess the Efficacy of AZD2281 in the Treatment of Patients With Platinum Sensitive Relapsed Serous Ovarian Cancer Following Treatment With Two or More Platinum Containing Regimens (Study 19)

Improved PFS and OS with olaparib maintenance

Ola vs Placebo:

All:
PFS: 8.4 vs 4.8 months*
OS: 29.8 vs 27.8 months*
BRCA WT:
PFS: 7.4 vs 5.5 months*
OS: 24.5 vs 26.6 months
BRCA MUT:
PFS: 11.2 vs 4.3 months*
OS: 34.9 vs 30.2 months*

v. 1/2017
*Statistically significant result

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