| 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; median 2 prior therapies |
| Therapy Setting | Maintenance |
| Study Design | Double Blind, Randomized |
| Endpoints | PFS, OS, PFS2, TFST, TSST, TTSP, 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): Exploratory analysis: Response to platinum or non-platinum chemotherapy after RECIST progression Placebo (n=69) vs Ola maint (n=78) |
| 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 Frenel JS et al. Efficacy of subsequent chemotherapy for patients with BRCA1/2-mutated recurrent epithelial ovarian cancer progressing on olaparib versus placebo maintenance: post-hoc analyses of the SOLO2/ENGOT Ov-21 trial. Ann Oncol (2022) 33(10):1021-1028 |