Trial ID # | NCT02354131; AVANOVA |
Phase | II |
Drug Class | Angiogenesis Inhibitors: VEGF |
Drug Name | Bevacizumab |
Alternate Drug Names | immunoglobulin G1 (human-mouse monoclonal rhuMab-VEGF gamma-chain, anti-VEGF monoclonal antibody, Avastin |
Drugs in Trial | Bevacizumab, Niraparib |
Eligible Participant | Platinum sensitive ovarian cancer, no prior PARP inhibitor |
Patients Enrolled | 109 (Phase I: 12; Phase II: Nir: 49; median 1 prior therapy; Nir+Bev: 48; median 2 prior therapies) |
Therapy Setting | Recurrence |
Study Design | Open-Label, Randomized |
Endpoints | ORR, DCR, PFS, OS, RP2D, TFST, evaluated per RECIST |
Biomarkers | Exploratory: HRD, gBRCA, CFI, prior bevacizumab |
Efficacy | AVANOVA1: AVANOVA2: ORR: 62 (7CR, 22PR, n=47) vs 30% (5CR, 8PR, n=44) (p=0.003) Exploratory subgroup analyses: HRD-status, gBRCA-status, CFI, prior Bev: HRD-: PFS: 11.3 (n=20) vs 4.2 (n=19) months, HR: 0.40 (0.19-0.85, p=0.0129) |
Clinically Significant Adverse Events | Nir+Bev vs Nir: |
Conclusion | Promising improvement of activity with niraparib+bevacizumab compared to niraparib alone |
Reference | Mirza MR et al. Niraparib plus bevacizumab versus niraparib alonefor platinum-sensitive recurrent ovarian cancer(NSGO-AVANOVA2/ENGOT-ov24): a randomised, phase 2, superiority trial. Lancet Oncol (2019) 20(10):1409-1419 Mirza MR et al. Final survival analysis of NSGO-AVANOVA2/ENGOT-OV24: Combination of niraparib and bevacizumab versus niraparib alone as treatment of recurrent platinum-sensitive ovarian cancer—A randomized controlled chemotherapy-free study. J Clin Oncol (2020) 38: (suppl; abstr 6012) Mirza MR et al. Poster |