Clinical Situation: Maintenance After Recurrence Treatment

Maintenance after therapy for recurrence: Treatment to control disease after complete or partial 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

2 Prior Therapies 3 Prior Therapies 4 Prior Therapies Prior Therapies Not Reported

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 NCT01874353; SOLO-2 III Olaparib Prescribing Information 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 and OS with olaparib maintenance treatment in gBRCA MUT patients

Ola vs Placebo:

PFS: 19.1 vs 5.5 months*
OS: 51.7 vs 38.8 months
TFST: 27.4 vs 7.2 months*

pub 2017, pub 2021

DNA Damage Repair Pathway Inhibitors: PARP NCT01847274; NOVA III Niraparib Prescribing Information 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; the benefit of niraparib maintenance therapy extends beyond first progression

Nir vs Placebo:

non-gBRCA MUT:
PFS: 9.3 vs 3.9 months*
gBRCA MUT:
PFS: 21.0 vs 5.5 months*
HRD-:
PFS: 6.9 vs 3.8 months*
HRD+ (excl. BRCA MUT):
PFS: 9.3 vs 3.7 months*

pub 2016, 2019, abs Mar 2021

DNA Damage Repair Pathway Inhibitors: PARP NCT01968213; ARIEL3 III Rucaparib Prescribing Information 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 or length of PFS interval, but most active in BRCA MUT

Ruc vs Placebo:

All:
PFS: 13.7 vs 5.4 months*
BRCA WT/LOH Low:
PFS: 8.2 vs 5.3 months*
BRCA WT/LOH High:
PFS: 11.1 vs 5.6 months*
BRCA MUT:
PFS: 26.8 vs 5.4 months*

pub 2017, pub 2020, abs Jun 2021 and poster, pub 2021

DNA Damage Repair Pathway Inhibitors: PARP NCT00753545; Study 19 II Olaparib Prescribing Information 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*

pub 2012; 2014; 2016

DNA Damage Repair Pathway Inhibitors: PARP NCT03402841; OPINION IIIb Olaparib Prescribing Information A Phase IIIb, Single-arm, Open-label Multicentre Study of Olaparib Maintenance Monotherapy in Platinum Sensitive Relapsed Non-Germline BRCA Mutated Ovarian Cancer Patients Who Are in Complete or Partial Response Following Platinum Based Chemotherapy

Maintenance olaparib demonstrates activity in non-gBRCA MUT ovarian cancer patients with no new safety signals

non-gBRCA MUT: PFS: 9.2 months
HRD-: PFS: 7.3 months
HRD+ (excl. sBRCA MUT): PFS: 9.7 months
sBRCA MUT: PFS: 14.5 months

abs May 2020 and poster

DNA Damage Repair Pathway Inhibitors: PARP NCT02476968; ORZORA IV Olaparib An Open Label, Single Arm, Multicentre Study to Assess the Clinical Effectiveness and Safety of Lynparza (Olaparib) Capsules Maintenance Monotherapy in Platinum Sensitive Relapsed Somatic or Germline BRCA Mutated Ovarian Cancer Patients Who Are in Complete or Partial Response Following Platinum Based Chemotherapy (ORZORA).

PFS in patients with platinum sensitive ovarian cancer who received maintenance olaparib is similar irrespective of somatic or germline BRCA status and activity of maintenance olaparib is also seen in patients with a non-BRCA HRR gene mutations

gBRCA MUT vs sBRCA MUT vs HRRm:
PFS: 18.0 vs 16.6 vs 16.4 months

abs Mar 2021

Drugs in Clinical Development
DNA Damage Repair Pathway Inhibitors: PARP NCT03106987; OReO/ENGOT Ov-38 III Olaparib A Phase IIIb, Randomised, Double-blind, Placebo-controlled, Multicentre Study of Olaparib Maintenance Retreatment in Patients With Epithelial Ovarian Cancer Previously Treated With a PARPi and Responding to Repeat Platinum Chemotherapy

Rechallenge with maintenance olaparib following response to Pt-based therapy provides a significant improvement in PFS vs placebo, irrespective of BRCA status

Ola vs Placebo:

BRCA MUT:
PFS: 4.3 vs 2.8 months*
PFS at 12 months: 19 vs 0%

non-BRCA MUT:
PFS: 5.3 vs 2.8 months*
PFS at 12 months: 12 vs 0%

abs Sept 2021

*Statistically significant result

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