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

Platinum resistant or refractory ovarian cancer

Phase 2: 40; median 2 prior therapies

Recurrence

Open-Label, Non-randomized

ORR, PFS, OS, evaluated per RECIST

Exploratory: LRP1B DEL, MYC AMP

ORR: 22.5% (4CR, 5PR, n=36)
PFS: 5.5 months
OS: 17.6 months

Exploratory analysis:
PFS for patients on PLD+Dur negatively correlated with LRP1B deletions (P = 0.0016)
Patients w/ MYC AMP had a lower response (P = 0.0005) and shorter PFS (P = 0.006, HR = 2.889) to PLD+Dur

Serious AE: overall (12.5%)
Grade 3-4 AE: PPE (27.5%), stomatitis (10%), decreased lymphocyte counts (10%)

Durvalumab+liposomal doxorubicin has a tolerable safety profile and promising efficacy

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
https://oncologypro.esmo.org/meeting-resources/esmo-2018-congress/A-phase-1-2-study-of-chemo-immunotherapy-with-durvalumab-durva-and-pegylated-liposomal-doxorubicin-PLD-in-platinum-resistant-recurrent-ovarian-cancer-PROC

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): Genomic sequencing and updated efficacy results. SGO (2020) abstract 51
https://sgo.confex.com/sgo/2020/meetingapp.cgi/Paper/14757