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 avelumab+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