Objectives VIRO-15 phase IB trial (NCT02759588) enrolled 11 patients with PROC, extensive tumor burden, and median 5 prior lines of therapy. We aimed to retrospectively determine factors that predict clinical benefit from VOV monotherapy in PROC.
Methods Patients received a modified VOV (GL-ONC1, Genelux Corp.) intra-peritoneally on two consecutive days. Four patients had apparent clinical benefit with >5 mos progression-free survival (PFS) following virotherapy (A). Seven (B) patients had <5 mo PFS. Comparative analyses included: measures of immune-competence with neutralizing antibody (NA) titers, virus-encoded glucuronidase activity (GA), tumor response by RECIST 1.1, Prognostic Nutritional Index (PNI), circulating tumor cells (CTCs), number of prior platinum and total therapies. Mann-Whitney test, t-test, z-test were used to evaluate differences between the groups.
Results Following GL-ONC1, the PFS was 10.9±5.1 and 2.4±1.1 mos for A vs B (p< 0.05). Mean OS for A was 21.7±8.2 mos vs 3.6±1.5 mos for B (p<0.05). Three A pts are alive, and one with stable disease died at 8-mos from pulmonary embolism. Factors that predicted clinical benefit were: i) PNI [mean 49.0±5.7 vs 42.1±4.3 (p<0.05)], ii) Week-5 CA125 values < Week-2 [4/4 vs 0/7 (p<0.01)], iii) absence of CTC [3/4 vs 1/7 pts (p<0.05)].
Conclusions Factors associated with clinical benefit post GL-ONC1 monotherapy in PROC include higher PNI, absence of CTCs, and Week-5 CA125 less than Week-2 levels. In the absence of these factors, cytotoxic therapy should be considered by Week-6 following GL-ONC1. Three patients are currently alive at 22.8–28.2 mos, following additional therapies.
Statistics from Altmetric.com
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.