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 Lynparza, AZD2281
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, 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), at 5 years follow up:

PFS: 56.0 vs 13.8 months, HR: 0.33 (0.25-0.43, P<0.0001)
PFS2: NR vs 41.9 months, HR: 0.50 (0.35-0.72, P=0.0002)
TFST: 51.8 vs 15.1 month, HR: 0.30 (0.22-0.40, P<0.0001)

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 12%), 3 deaths due to AML in olaparib arm (1.2%)
Grade 3-4 AE: any (39 vs 18%), anemia (22 vs 2%)


Considerably improved PFS for BRCA MUT patients with olaparib maintenance treatment


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

Colombo N et al. Adverse events (AEs) with maintenance olaparib in newly diagnosed patients (pts) with advanced ovarian cancer (OC) and a BRCA mutation (BRCAm): Phase III SOLO1 trial. J Clin Oncol (2019) 37 (suppl; abstr 5539)

Banerjee S et al. Maintenance olaparib for patients (pts) with newly diagnosed, advanced ovarian cancer (OC) and a BRCA mutation (BRCAm): 5-year (y) follow-up (f/u) from SOLO1. Annals Oncol (2020) 31 (suppl_4): abstract 811 MO