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

Recurrence

Study Design

Open-Label, Randomized

Endpoints

ORR, PFS, evaluated per RECIST

Biomarkers

gBRCA1/2 MUT

Efficacy

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%)

Conclusion

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

Reference

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)
https://meetinglibrary.asco.org/record/173435/abstract