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 AZD2281, Lynparza
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

Therapy Setting

Maintenance

Study Design

Double Blind, Randomized

Endpoints

PFS, evaluated per RECIST

Biomarkers

gBRCA1/2 MUT

Efficacy

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

All patients gBRCA MUT:
PFS: 30.2 vs 5.5 months, HR: 0.25 (0.18-0.35, p<0.0001)

Ola maint (n=196) vs Placebo (n=99) (investigator review):

All patients gBRCA MUT:
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%)

Conclusion

Improved PFS with olaparib tablets maintenance treatment for gBRCA patients

Reference

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
https://www.ncbi.nlm.nih.gov/pubmed/28754483