A Phase I/II Trial of Multiple Dose VB-111 and Weekly Paclitaxel for the Treatment of Recurrent Platinum-Resistant Müllerian Cancer

Trial ID #	NCT01711970
Phase	I/II
Drug Class	Angiogenesis Inhibitors: Gene Therapy
Drug Name	Ofranergene obadenovec
Alternate Drug Names	VB-111
Drugs in Trial	Ofranergene obadenovec, Paclitaxel
Eligible Participant	Platinum resistant ovarian cancer
Patients Enrolled	21; median 3 prior therapies; 48% Pt-Rf; 47% w/ prior bevacizumab
Therapy Setting	Recurrence
Study Design	Open-Label, Non-randomized
Endpoints	ORR, DCR, DoR, OS, evaluated per RECIST or CA125
Efficacy	21 patients (4 sub-therapeutic dose, 17 therapeutic dose) ORR (RECIST): 13% (2PR, n=15) DCR: 73% (2PR, 9SD) ORR (CA125): 58% (n=12) DoR: 10 months OS: 16.6 (therapeutic dose, n=17) vs 5.8 months (sub-therapeutic dose, n=4)(p=0.03)
Clinically Significant Adverse Events	Serious AE: overall (29%) Grade 3-4 AE: overall (43%), fatigue (52%), nausea (52%), fever (48%), anemia (38%), diarrhea (33%), headache (29%)
Conclusion	Ofranergene Obadenovec+weekly paclitaxel is safe and well tolerated; tumor responses are associated with tumor infiltration of CD8 T-cells
Reference	Arend RC et al. Ofranergene Obadenovec (VB-111) in Platinum-Resistant Ovarian Cancer; Favorable Response Rates in a Phase I/II Study Are Associated With an Immunotherapeutic Effect. Gynecol Oncol (2020) 157(3):578-584 https://pubmed.ncbi.nlm.nih.gov/32265057/