Utilizing an interim futility analysis of the OVAL study (VB-111-701/GOG 3018) for potential reduction of risk: A phase III, double blind, randomized controlled trial of ofranergene obadenovec (VB-111) and weekly paclitaxel in patients with platinum resistant ovarian cancer.
Document Type
Article
Publication Date
2-23-2021
Publication Title
Gynecologic oncology
Keywords
california; orange; sjh
Abstract
OBJECTIVE: Report the results from a preplanned interim analysis of a phase III, double blind, randomized controlled study of ofranergene obadenovec (VB-111), a targeted anti-cancer gene therapy, in combination with paclitaxel in patients with platinum resistant ovarian cancer (PROC).
METHODS: The OVAL (NCT03398655) study is an on-going study where patients are randomly assigned in a 1:1 ratio to weekly paclitaxel 80 mg/m
RESULTS: The median age of the evaluable patients was 62 years (range 41-82); 97% had high-grade serous cancer; 58% had been treated with 3 or more previous lines of therapy, 70% received prior anti-angiogenic treatment, 43% received prior PARP inhibitors. CA-125 response in the VB-111 and weekly paclitaxel treated arm met the pre-specified interim criterion of an absolute advantage of 10% or higher compared to the control. Blinded results show a 53% CA-125 response rate (32/60) with 15% complete response (n=9). Assuming balanced randomization and an absolute advantage of 10% or higher to the VB-111 arm, it may be deducted that the response in the VB-111 treatment arm is 58% or higher. Among patients with post-treatment fever, the CA-125 response rate was 69%.
CONCLUSIONS: At the time of the interim analysis, response rate findings are comparable to the responses seen in a similar patient population in the phase I/II study. The independent data and safety monitoring committee (iDSMC) recommended continuing the OVAL trial as planned. No new safety signals were identified.
Clinical Institute
Cancer
Clinical Institute
Women & Children
Department
Obstetrics & Gynecology
Department
Oncology
Recommended Citation
Arend, Rebecca C; Monk, Bradley J; Herzog, Thomas J; Moore, Kathleen N; Shapira-Frommer, Ronnie; Ledermann, Jonathan A; Tewari, Krishnansu S; Secord, Angeles Alvarez; Minei, Tamar Rachmilewitz; Freedman, Laurence S; Miller, Austin; Shmueli, Shifra Fain; Lavi, Michal; and Penson, Richard T, "Utilizing an interim futility analysis of the OVAL study (VB-111-701/GOG 3018) for potential reduction of risk: A phase III, double blind, randomized controlled trial of ofranergene obadenovec (VB-111) and weekly paclitaxel in patients with platinum resistant ovarian cancer." (2021). Articles, Abstracts, and Reports. 4500.
https://digitalcommons.providence.org/publications/4500
