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

PLD vs Ave vs Ave+PLD:

ORR: 4.2 vs 3.7 vs 13.3%

PLD vs Ave+PLD:
PFS: HR: 0.78 (0.587-1.244, p=0.0301)
OS: HR: 0.89 (0.744-1.241, p=0.2082)

PLD vs Ave:
PFS: HR: 1.68 (1.320-2.601, p>0.99)
OS: HR: 1.14 (0.948-1.580, p=0.8253)

Clinically Significant Adverse Events

No new safety signals reported with either avelumab monotherapy or with the combination

Conclusion

No significant improvement in ORR, PFS or OS with the combination of avelumab and liposomal doxorubicin compared to avelumab or PLD alone

Reference

Columbus, G. "Avelumab Misses Primary Endpoints in Phase III Ovarian Cancer Trial" Onc Live article, 11/19/18
https://www.onclive.com/web-exclusives/avelumab-misses-primary-endpoints-in-phase-iii-ovarian-cancer-trial