| Trial ID # | NCT03038100; IMagyn050 |
| 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, Bevacizumab, Carboplatin, Paclitaxel |
| Eligible Participant | Newly diagnosed stage III/IV ovarian cancer (neo-adjuvant or adjuvant and maintenance) |
| Patients Enrolled | 1301 |
| Therapy Setting | First-line |
| Study Design | Double Blind, Randomized |
| Endpoints | PFS, evaluated per RECIST |
| Biomarkers | PD-L1+; Exploratory: poor prognosis w/unfavorable KELIM score < 1.0 and sub-optimal debulking surgery |
| Efficacy | CarboPt+Pac+Bev+Aze w/ Bev+Aze maint vs CarboPt+Pac+Bev+Placebo w/ Bev+Placebo maint: PD-L1+ patients: patients with ≥ 1% of tumor-infiltrating immune cells expressing PD-L1: Exploratory analysis: poor prognosis w/unfavorable KELIM score < 1.0 and sub-optimal debulking surgery: |
| Clinically Significant Adverse Events | CarboPt+Pac+Bev+Aze w/ Bev+Aze maint vs CarboPt+Pac+Bev+Placebo w/ Bev+Placebo maint: |
| Conclusion | Atezolizumab does not significantly improve PFS or OS in the ITT or PD-L1+ population, but the poor prognostic subgroup of patients (unfavorable KELIM score and sub-optimal surgery), might derive a significant PFS benefit from the treatment intensification with atezolizumab |
| Reference | Moore KN et al. Atezolizumab, Bevacizumab, and Chemotherapy for Newly Diagnosed Stage III or IV Ovarian Cancer: Placebo-Controlled Randomized Phase III Trial (IMagyn050/GOG 3015/ENGOT-OV39). J Clin Oncol (2021) 39(17):1842-1855 Pignata S et al. Overall survival and patient-reported outcome results from the placebo-controlled randomized phase III IMagyn050/GOG 3015/ENGOT-OV39 trial of atezolizumab for newly diagnosed stage III/IV ovarian cancer. Gynecol Oncol (2023) 177:20-31 You B et al. Benefit from atezolizumab in patients with a poor prognostic ovarian cancer in first-line setting: IMAGYN-050 trial. Int J Gyn Cancer (2024);34:A37. |
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