A Phase 1/2 Study of Chemo-immunotherapy With Toll-like Receptor 8 Agonist Motolimod (VTX-2337) and Anti-PD-L1 Antibody MEDI4736 in Subjects With Recurrent, Platinum-Resistant Ovarian Cancer for Whom Pegylated Liposomal Doxorubicin (PLD) is Indicated

Trial ID # NCT02431559
Phase II
Drug Class Immunotherapy: Checkpoint Inhibitors/PD-L1
Drug Name Durvalumab
Alternate Drug Names Anti-B7H1 Monoclonal Antibody MEDI4736, MEDI4736, Imfinzi
Drugs in Trial Durvalumab, Liposomal doxorubicin
Eligible Participant

Platinum-resistant or refractory ovarian cancer

Patients Enrolled

Phase 2: 40, median 2 prior therapies

Therapy Setting

Recurrence

Study Design

Open-Label, Non-randomized

Endpoints

ORR, DCR, PFS, evaluated per RECIST

Efficacy

ORR: 15% (2CR, 4PR, n=40)
DCR: 60% (2CR, 4PR, 18SD, n=40)
PFS: 5.5 months (2.8-8.3)

Clinically Significant Adverse Events

Serious AE: overall (12.5%)
Grade 3-4 AE: overall (87.5%), stomatitis (10%), PPE (10%)

Conclusion

The combination of durvalumab+liposomal doxorubicin has a tolerable safety profile and promising efficacy

Reference

O'Cearbhaill RE et al. A Phase I/II study of chemo/immunotherapy with durvalumab (durva) and pegylated liposomal doxorubicin (PLD) in platinum-resistant recurrent ovarian cancer (PROC) Ann Oncol (2018) 29 Suppl_8, Abstract 945P, Poster
https://poster-submission.com/esmo2018/visitors/eposter/37167