Trial ID # | NCT02446600; NRG-GY004 |
Phase | III |
Drug Class | DNA Damage Repair Pathway Inhibitors: PARP |
Drug Name | Olaparib |
Alternate Drug Names | AZD2281, Lynparza |
Drugs in Trial | Carboplatin, Cediranib, Gemcitabine, Liposomal doxorubicin, Paclitaxel, Olaparib |
Eligible Participant | Platinum sensitive high grade serous or endometrioid ovarian cancer or germline BRCA1/2-mutated ovarian cancer, no prior PARP inhibitor |
Patients Enrolled | 565, median 1 prior therapy |
Therapy Setting | Recurrence |
Study Design | Open-Label, Randomized |
Endpoints | ORR, PFS, OS, evaluated per RECIST |
Efficacy | Ola+Ced (n=189) vs Ola (n=189) vs Treatment of Physician's Choice (TPC) (CarboPt+Gem (27%)/PLD (48%)/Pac (25%)) (n=187): ORR: 69.4 vs 52.4 vs 71.3% |
Clinically Significant Adverse Events | Ola+Ced vs Ola vs TPC: |
Conclusion | Cediranib+olaparib has similar activity to standard of care in relapsed platinum sensitive ovarian cancer but does not improve PFS |
Reference | Lui JF et al. A phase III study comparing single-agent olaparib or the combination of cediranib and olaparib to standard platinum-based chemotherapy in recurrent platinum-sensitive ovarian cancer. J Clin Oncol (2020) 38: (suppl; abstr 6003) |