A Randomized, Open-Label, Multicenter, Phase 3 Study To Evaluate The Efficacy And Safety Of Avelumab (MSB0010718C) In Combination With And/Or Following Chemotherapy In Patients With Previously Untreated Epithelial Ovarian Cancer Javelin Ovarian 100

Trial ID #	NCT02718417; JAVELIN Ovarian 100
Phase	III
Drug Class	Immunotherapy: Checkpoint Inhibitors/PD-L1
Drug Name	Avelumab
Alternate Drug Names	Anti programmed death ligand 1 monoclonal antibody, Anti-PD-L1, MSB0010718C, Bavencio
Drugs in Trial	Avelumab, Carboplatin, Paclitaxel
Eligible Participant	Newly diagnosed stage III/IV ovarian cancer (neo-adjuvant or adjuvant and maintenance)
Patients Enrolled	998
Therapy Setting	Maintenance
Study Design	Open-Label, Randomized
Endpoints	ORR, PFS, evaluated per RECIST
Efficacy	CarboPt+Pac+Ave+Ave maint vs CarboPt+Pac+Ave maint vs CarboPt+Pac: ORR: 36.0 vs 30.4 vs 30.4% PFS: 18.1 vs 16.8 vs NR months; HR: 1.14 (0.83-1.56, p=0.79); HR: 1.43 (1.05-1.95 p=0.99)
Clinically Significant Adverse Events	CarboPt+Pac+Ave+Ave maint vs CarboPt+Pac+Ave maint vs CarboPt+Pac: Serious AE: overall (36 vs 28 vs 19%) Grade 3-4 AE: overall (70.8 vs 66.5 vs 62.6%), neutropenia (30 vs 28 vs 6%)
Conclusion	Avelumab addition to carboplatin+paclitaxel and/or continued as maintenance therapy for newly diagnosed ovarian cancer patients does not improve PFS; PD-L1, CD8, and gBRCA1/2 status did not predict differential clinical benefit
Reference	Monk BJ et al. Chemotherapy with or without avelumab followed by avelumab maintenance versus chemotherapy alone in patients with previously untreated epithelial ovarian cancer (JAVELIN Ovarian 100): an open-label, randomised, phase 3 trial. Lancet Oncol (2021) 22(9):1275-1289 https://pubmed.ncbi.nlm.nih.gov/34363762/