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 Lynparza, AZD2281
Drugs in Trial Gemcitabine, Liposomal doxorubicin, Olaparib, Paclitaxel, Topotecan
Eligible Participant

Platinum sensitive, gBRCA MUT ovarian cancer with ≥ 2 prior therapies, no prior PARP inhibitor

Patients Enrolled

266, median 2 prior therapies

Therapy Setting

Recurrence

Study Design

Open-Label, Randomized

Endpoints

ORR, DCR, DoR, PFS, evaluated per RECIST

Biomarkers

gBRCA1/2 MUT

Efficacy

Olaparib (n=178) vs Treatment of Physician's Choice (TPC) of non-platinum chemotherapy (n=88): Gem (n=13), Pac (n=20), PLD (n=47) or Top (n=8):

ORR: 72.2 (14CR, 95PR, n=151) vs 51.4% (2CR, 35PR, n=72)(p=0.002)
DCR: 88.7 (14CR, 95PR, 25SD, n=151) vs 77.8% (2CR, 35PR, 19SD, n=72) (SD for ≥ 8 weeks)
DoR: 9.4 vs 10.2 months
PFS: 13.4 vs 9.2 months, HR: 0.62 (0.43-0.91, p=0.013)

Exploratory analysis, 2 prior therapies:
ORR: 84.6 vs 61.5%

Clinically Significant Adverse Events

Ola vs TPC:
Serious AE: overall (24 vs 18%), MDS/AML (2.2 vs 3.9%)
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 nonplatinum chemotherapy

Reference

Penson RT et al. Olaparib Versus Nonplatinum Chemotherapy in Patients With Platinum-Sensitive Relapsed Ovarian Cancer and a Germline BRCA1/2 Mutation (SOLO3): A Randomized Phase III Trial. J Clin Oncol (2020) 38(11): 1164-1174
https://www.ncbi.nlm.nih.gov/pubmed/32073956