A Phase III, Open Label, Randomised, Controlled, Multi-centre Study to Assess the Efficacy and Safety of Olaparib Monotherapy Versus Physician's Choice Single Agent Chemotherapy in the Treatment of Platinum Sensitive Relapsed Ovarian Cancer in Patients Carrying Germline BRCA1/2 Mutations.

Trial ID # NCT02282020; SOLO-3
Phase III
Drug Class DNA Damage Repair Pathway Inhibitors: PARP
Drug Name Olaparib
Alternate Drug Names AZD2281, Lynparza
Drugs in Trial Gemcitabine, Liposomal doxorubicin, Olaparib, Paclitaxel, Topotecan
Eligible Participant

Platinum-sensitive, gBRCA1/2-mutated ovarian cancer with ≥ 2 prior therapies

Patients Enrolled

266, median 2 prior therapies

Therapy Setting


Study Design

Open-Label, Randomized


ORR, PFS, evaluated per RECIST




Olaparib vs Treatment of Physician's Choice (TPC) of non-platinum chemotherapy: Gem, Pac, PLD or Top:

ORR: 72 vs 51% (p=0.002)
PFS: 13.4 vs 9.2 months, HR: 0.62 (0.43-0.91, p=0.013)

Clinically Significant Adverse Events

Ola vs TPC:
Serious AE: overall (24 vs 18%)
Grade 3-4 AE: anemia (21 vs 0%), PPE (0 vs 12%), neutropenia (10 vs 16%)


Improved ORR and PFS for gBRCA MUT patients treated with olaparib vs non-platinum chemotherapy


Penson RT et al. Olaparib monotherapy versus(vs) chemotherapy for germline BRCA-mutated (gBRCAm) platinum-sensitive relapsed ovarian cancer (PSR OC) patients (pts): Phase III SOLO3 trial. J Clin Oncol (2019) 37 (suppl; abstr 5506)