A Phase 3, Multicenter, Randomized, Open-Label Study Of Avelumab (MSB0010718C) Alone Or In Combination With Pegylated Liposomal Doxorubicin Versus Pegylated Liposomal Doxorubicin Alone In Patients With Platinum-Resistant/Refractory Ovarian Cancer

Trial ID #	NCT02580058; JAVELIN Ovarian 200
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, Liposomal doxorubicin
Eligible Participant	Platinum resistant or refractory ovarian cancer with < 4 prior therapies
Patients Enrolled	556
Therapy Setting	Recurrence
Study Design	Open-Label, Randomized
Endpoints	ORR, PFS, OS, evaluated per RECIST
Efficacy	Ave+PLD vs Ave vs PLD: ORR: 13.3 vs 3.7 vs 4.2% PFS: 3.7 vs 1.9 vs 3.5 months, HR: 0.78 (0.59-1.24, p=0.03); HR: 1.68 (1.32-2.60, p>0.99) OS: 15.7 vs 11.8 vs 13.1 months, HR: 0.89 (0.74-1.24, p=0.21); HR: 1.14 (0.95-1.59, p=0.03) Exploratory analysis, PD-L1 levels: Ave+PLD: PD-L1+ vs PD-L1-: ORR: 19.5 vs 3.4%
Clinically Significant Adverse Events	Ave+PLD vs Ave vs PLD: Serious AE: 18 vs 7 vs 11% Grade 3-4 AE: PPE/Hand-Foot Syndrome (10 vs 0 vs 9%)
Conclusion	No significant improvement in ORR, PFS or OS with avelumab+liposomal doxorubicin compared to avelumab or PLD alone
Reference	Pujade-Lauraine E et al. Avelumab alone or in combination with chemotherapy versus chemotherapy alone in platinum-resistant or platinum-refractory ovarian cancer (JAVELIN Ovarian 200): an open-label, three-arm, randomised, phase 3 study. Lancet Oncol (2021) 22(7):1034-1046 https://pubmed.ncbi.nlm.nih.gov/34143970/