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 | Maintenance |
Study Design | Double Blind, Randomized |
Endpoints | PFS, OS, TFST, evaluated per RECIST |
Biomarkers | gBRCA1/2 MUT |
Efficacy | Ola maint (n=196) vs Placebo (n=99): PFS: 19.1 vs 5.5 months, HR: 0.30 (0.22-0.41, p<0.0001) Ola maint (n=196) vs Placebo (n=99) (adjusted for subsequent PARP inhibitor therapy in Placebo group): |
Clinically Significant Adverse Events | Ola vs Placebo: |
Conclusion | Improved PFS and OS with olaparib maintenance treatment for gBRCA MUT 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 Poveda A et al. Olaparib tablets as maintenance therapy in patients with platinum-sensitive relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT-Ov21): a final analysis of a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol (2021) 22(5):620-631 |