| Trial ID # | NCT01844986; SOLO-1 |
| Phase | III |
| Drug Class | DNA Damage Repair Pathway Inhibitors: PARP |
| Drug Name | Olaparib |
| Alternate Drug Names | AZD2281, Lynparza |
| Drugs in Trial | Olaparib |
| Eligible Participant | Stage III or IV, BRCA MUT, high grade serous or endometrioid, CR or PR after first-line therapy |
| Patients Enrolled | 451 |
| Therapy Setting | Maintenance |
| Study Design | Randomized |
| Endpoints | PFS, OS, PFS2, TFST, TSST, evaluated per RECIST |
| Biomarkers | BRCA1/2 MUT; Exploratory: timing of surgery, residual disease status after surgery, CR/PR after chemo |
| Efficacy | Ola maint (n=260) vs Placebo (n=131): PFS: 56.0 vs 13.8 months, HR: 0.33 (0.25-0.43, P<0.0001) Exploratory analyses: |
| Clinically Significant Adverse Events | Ola maint vs Placebo: |
| Conclusion | Considerably improved PFS and OS for BRCA MUT patients with olaparib maintenance treatment; the benefit derived from 2 years of maintenance olaparib is sustained beyond the end of treatment |
| Reference | Moore KN et al. Maintenance Olaparib in Patients with Newly Diagnosed Advanced Ovarian Cancer. N Engl J Med (2018) 379(26): 2495-2505 Banerjee S et al. Maintenance olaparib for patients with newly diagnosed advanced ovarian cancer and a BRCA mutation (SOLO1/GOG 3004): 5-year follow-up of a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet (2021) 22(12):1721-1731 DiSilvestro P et al. Overall Survival With Maintenance Olaparib at a 7-Year Follow-Up in Patients With Newly Diagnosed Advanced Ovarian Cancer and a BRCA Mutation: The SOLO1/GOG 3004 Trial. J Clin Oncol (2023) 41(3):609-617 |