Trial ID # | NCT02446600; NRG-GY004 |
Phase | III |
Drug Class | Angiogenesis Inhibitors: VEGFR |
Drug Name | Cediranib |
Alternate Drug Names | Recentin, Cediranib maleate, AZD2171 |
Drugs in Trial | Carboplatin, Cediranib, Liposomal doxorubicin, Olaparib, Paclitaxel, Gemcitabine |
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 |
Biomarkers | Exploratory: BROCA-HR |
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 or OS |
Reference | Liu J et al. Olaparib With or Without Cediranib Versus Platinum-Based Chemotherapy in Recurrent Platinum-Sensitive Ovarian Cancer (NRG-GY004): A Randomized, Open-Label, Phase III Trial. J Clin Oncol (2022) 40(19):2138-2147 Liu JF et al. Overall survival (OS) outcomes from NRG-GY004, a phase III study comparing single-agent olaparib or combination cediranib and olaparib to platinum (Plat) based chemotherapy in recurrent plat sensitive ovarian cancer (OvCa). Ann Oncol (2023) 34(2) abstract LBA45 |