Ofranergene Obadenovec (Ofra-Vec, VB-111) With Weekly Paclitaxel for Platinum-Resistant Ovarian Cancer: Randomized...

Area of Science:

• Oncology
• Genetics
• Clinical Trials

Background:

• Recurrent platinum-resistant ovarian cancer (PROC) has limited treatment options.
• Novel therapeutic strategies are needed to improve outcomes for patients with PROC.

Purpose of the Study:

• To evaluate the efficacy and safety of ofranergene obadenovec (ofra-vec), a gene-based therapy, in combination with paclitaxel for PROC.
• To assess the impact of ofra-vec on progression-free survival (PFS) and overall survival (OS) in patients with PROC.

Main Methods:

• A phase III, placebo-controlled, double-blind trial (NCT03398655) enrolled 409 patients with PROC.
• Patients received either ofra-vec plus paclitaxel or placebo plus paclitaxel weekly until disease progression.
• Dual primary endpoints were PFS and OS, assessed by Blinded Independent Central Review.

Main Results:

• Median PFS was 5.29 months with ofra-vec versus 5.36 months with placebo (HR 1.03, P = .7823).
• Median OS was 13.37 months with ofra-vec versus 13.14 months with placebo (HR 0.97, P = .8440).
• Objective response rates (ORRs) were similar (28.9% vs 29.6%). CA-125 response was a significant prognostic factor for PFS and OS.

Conclusions:

• The addition of ofra-vec to paclitaxel did not improve PFS or OS in patients with PROC.
• Control arm outcomes exceeded expectations based on prior studies.
• CA-125 response emerged as a strong prognostic biomarker for treatment outcomes in PROC.