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)

Trial ID # NCT01844986; SOLO-1
Phase III
Drug Class DNA Damage Repair Pathway Inhibitors: PARP
Drug Name Olaparib
Alternate Drug Names AZD2281, Lynparza
Drugs in Trial Olaparib
Eligible Participant

Stage III or IV, BRCA MUT, high grade serous or endometrioid, CR or PR after first-line therapy

Patients Enrolled


Therapy Setting


Study Design



PFS, OS, PFS2, TFST, TSST, evaluated per RECIST


BRCA1/2 MUT; Exploratory: timing of surgery, residual disease status after surgery, CR/PR after chemo


Ola maint (n=260) vs Placebo (n=131):

PFS: 56.0 vs 13.8 months, HR: 0.33 (0.25-0.43, P<0.0001)
PFS (5 years): 48 vs 21%
PFS2: NR vs 41.9 months, HR: 0.50 (0.35-0.72, P=0.0002)
TFST: 64.0 vs 15.1 months, HR: 0.37 (0.28-0.48)
TSST: 93.2 vs 40.7 months, HR: 0.50 (0.37-0.67)
OS: NR vs 75.2 months, HR: 0.55 (0.40-0.76, p=0.0004) at 7 years of follow up
OS at 7 years: 67.0 vs 46.5%

Exploratory analyses:
Upfront surgery: PFS: NR vs 15.3 months; HR: 0.31 (0.21–0.46)
Interval surgery: PFS: 33.6 vs 9.8 months; HR: 0.37 (0.24–0.58)
Residual disease after surgery: PFS: 29.4 vs 11.3 months; HR: 0.44 (0.25–0.77)
No residual disease after surgery: PFS: NR vs 15.3 months; HR: 0.33 (0.23–0.46)
CR after chemotherapy: PFS: NR vs 15.3 months; HR: 0.34 (0.24–0.47)
PR after chemotherapy: PFS: 30.9 vs 8.4 months; HR: 0.31 (0.18–0.52)

Clinically Significant Adverse Events

Ola maint vs Placebo:
Serious AE: any (21 vs 14%), MDS/AML (1.5% vs 0.8%)
Grade 3-4 AE: any (40 vs 20%), anemia (22 vs 2%)


Considerably improved PFS and OS for BRCA MUT patients with olaparib maintenance treatment; the benefit derived from 2 years of maintenance olaparib is sustained beyond the end of treatment


Moore KN et al. Maintenance Olaparib in Patients with Newly Diagnosed Advanced Ovarian Cancer. N Engl J Med (2018) 379(26): 2495-2505

Banerjee S et al. Maintenance olaparib for patients with newly diagnosed advanced ovarian cancer and a BRCA mutation (SOLO1/GOG 3004): 5-year follow-up of a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet (2021) 22(12):1721-1731

DiSilvestro P et al. Overall Survival With Maintenance Olaparib at a 7-Year Follow-Up in Patients With Newly Diagnosed Advanced Ovarian Cancer and a BRCA Mutation: The SOLO1/GOG 3004 Trial. J Clin Oncol (2023) 41(3):609-617

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