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+ |
Efficacy | CarboPt+Pac+Bev+Aze w/ Bev+Aze maint vs CarboPt+Pac+Bev+Placebo w/ Bev+Placebo maint: PFS: 19.5 vs 18.4 months, HR: 0.92 (0.79–1.07) PD-L1+ patients: patients with ≥ 1% of tumor-infiltrating immune cells expressing PD-L1: |
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. The combination is generally well tolerated with manageable AEs; neither BRCA1/2 MUT nor HRD+ was associated with greater clinical benefit from adding 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 |