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)

Trial ID # NCT01874353; SOLO-2
Phase III
Drug Class DNA Damage Repair Pathway Inhibitors: PARP
Drug Name Olaparib
Alternate Drug Names Lynparza, AZD2281
Drugs in Trial Olaparib
Eligible Participant

gBRCA MUT with Pt-sensitive recurrence and CR or PR in most recent Pt-based therapy, ≥ 2 Pt-based regimens

Patients Enrolled

295, median 2 prior therapies

Therapy Setting


Study Design

Double Blind, Randomized


PFS, OS, TFST, evaluated per RECIST




Ola maint (n=196) vs Placebo (n=99) (BICR):

PFS: 30.2 vs 5.5 months, HR: 0.25 (0.18-0.35, p<0.0001)
OS: 51.7 vs 38.8 months, HR: 0.74 (0.54-1.00, p=0.0537)
TFST: 27.4 vs 7.2 months, HR: 0.37 (0.28-0.48, p<0.0001)

Exploratory analysis, investigator review:

PFS: 19.1 vs 5.5 months, HR: 0.30 (0.22-0.41, p<0.0001)

Clinically Significant Adverse Events

Ola vs Placebo:
Serious AE: any (17.9 vs 8.1%), one treatment-related death in Ola arm (AML)
Grade 3-4 AE: overall (36.9 vs 18.2%), anemia (19.5 vs 2.0%), neutropenia (5.1 vs 4.0%)


Improved PFS and OS with olaparib tablets maintenance treatment for gBRCA patients


Pujade-Lauraine E et al. Olaparib tablets as maintenance therapy in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT-Ov21): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol (2017) 18:1274-84

Poveda A et al. Final overall survival (OS) results from SOLO2/ENGOT-ov21: A phase III trial assessing maintenance olaparib in patients (pts) with platinum-sensitive, relapsed ovarian cancer and a BRCA mutation. ASCO (2020) abstract 6002