| 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) (BICR): PFS: 30.2 vs 5.5 months, HR: 0.25 (0.18-0.35, p<0.0001) Exploratory analysis, investigator review: PFS: 19.1 vs 5.5 months, HR: 0.30 (0.22-0.41, p<0.0001) |
| Clinically Significant Adverse Events | Ola vs Placebo: |
| Conclusion | Improved PFS and OS 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 Poveda A et al. Final overall survival (OS) results from SOLO2/ENGOT-ov21: A phase III trial assessing maintenance olaparib in patients (pts) with platinum-sensitive, relapsed ovarian cancer and a BRCA mutation. ASCO (2020) abstract 6002 |