A Phase III, Multicenter, Randomized, Study of Atezolizumab Versus Placebo Administered in Combination With Paclitaxel, Carboplatin, and Bevacizumab to Patients With Newly-Diagnosed Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

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+Tax+Bev+Aze w/ Bev+Aze maint vs CarboPt+Tax+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:
PFS: 20.8 vs 18.5 months, HR 0.80 (0.65–0.99)

Clinically Significant Adverse Events

CarboPt+Tax+Bev+Aze w/ Bev+Aze maint vs CarboPt+Tax+Bev+Placebo w/ Bev+Placebo maint:
Serious AE:
Grade 3-4 AE:

Conclusion

Atezolizumab does not significantly improve PFS 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
https://pubmed.ncbi.nlm.nih.gov/33891472/

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