| Trial ID # | NCT03598270; ANITA |
| Phase | III |
| Drug Class | Immunotherapy: Checkpoint Inhibitors/PD-L1 |
| Drug Name | Atezolizumab |
| Alternate Drug Names | Tecentriq, Anti-PD-L1 Monoclonal Antibody MPDL3280A , MPDL3280A, RG7446 |
| Drugs in Trial | Atezolizumab, Carboplatin, Liposomal doxorubicin, Niraparib, Paclitaxel, Gemcitabine |
| Eligible Participant | Platinum sensitive ovarian cancer at first or second recurrence |
| Patients Enrolled | 417 |
| Therapy Setting | Recurrence |
| Study Design | Double Blind, Randomized |
| Endpoints | ORR, PFS, evaluated per RECIST |
| Biomarkers | PD-L1 status |
| Efficacy | CarboPt+Gem/Pac/PLD+Aze w/Nir+Aze maint (n=209) vs CarboPt+Gem/Pac/PLD+Placebo w/ Nir+Placebo maint (n=208): ORR: 45 vs 43% PD-L1+: PD-L1-: |
| Clinically Significant Adverse Events | CarboPt+Gem/Pac/PLD+Aze w/Nir+Aze maint vs CarboPt+Gem/Pac/PLD+Placebo w/ Nir+Placebo maint: |
| Conclusion | Combining atezolizumab with chemotherapy and maintenance niraparib for platinum sensitive recurrent OC does not significantly improve ORR or PFS; no difference in treatment effect according to PD-L1 status |
| Reference | Gonzalez Martin A et al. Atezolizumab (atezo) combined with platinum-based chemotherapy (CT) and maintenance niraparib for recurrent ovarian cancer (rOC) with a platinum-free interval (TFIp) >6 months: Primary analysis of the double-blind placebo (pbo)-controlled ENGOT-Ov41/GEICO 69-O/ANITA phase III trial. Ann Oncol (2023) 34(2) abstract LBA37 |