A Randomized, Double-blinded, Phase III Study of Atezolizumab Versus Placebo in Patients With Late Relapse of Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer Treated by Platinum-based Chemotherapy and Bevacizumab

Trial ID #	NCT02891824; ATALANTE
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, Liposomal doxorubicin, Paclitaxel, Gemcitabine
Eligible Participant	Platinum sensitive ovarian cancer at first or second recurrence
Patients Enrolled	614
Therapy Setting	Recurrence
Study Design	Double Blind, Randomized
Endpoints	PFS, OS, evaluated per RECIST
Biomarkers	PD-L1
Efficacy	CarboPt+Gem/Pac/PLD+Bev+Aze w/Bev+Aze maint (n=410) vs CarboPt+Gem/Pac/PLD+Bev+Placebo w/ Bev+Placebo maint (n=204): PFS: 13.5 vs 11.3 months, HR: 0.83 (0.69-0.99, p=0.041) OS: 35.5 vs 30.6 months, HR: 0.81 (0.65-1.01) PD-L1+: PFS: 15.2 vs 13.1 months, HR: 0.86 (0.63-1.16, p=0.30)
Clinically Significant Adverse Events	CarboPt+Gem/Pac/PLD+Bev+Aze w/Bev+Aze maint vs CarboPt+Gem/Pac/PLD+Bev+Placebo w/ Bev+Placebo maint: Serious AE: Grade 3-4 AE: overall (33 vs 35%); AE of special interest for ate (13 vs 8%)
Conclusion	Atezolizumab does not improve PFS in the overall population or in the patients with PD-L1 positive tumors
Reference	Kurtz J-E. et al. Atezolizumab Combined With Bevacizumab and Platinum-Based Therapy for Platinum-Sensitive Ovarian Cancer: Placebo-Controlled Randomized Phase III ATALANTE/ENGOT-ov29 Trial. J Clin Oncol (2023) 41(30):4768-4778 https://pubmed.ncbi.nlm.nih.gov/37643382/