Gene therapy fails to significantly extend survival in ovarian cancer, topline data show
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A phase 3 trial of ofranergene obadenovec in platinum-resistant ovarian cancer failed to meet its primary endpoints of statistically significant improvement in PFS and OS, according to topline data released by the agent’s manufacturer.
Ofranergene obadenovec, or ofra-vec (VB-111, VBL Therapeutics), is an investigational, targeted anticancer gene-therapy designed to treat multiple types of solid tumors, according to the manufacturer’s website.
The international, randomized phase 3 OVAL trial, conducted in collaboration with the GOG Foundation, evaluated ofra-vec plus paclitaxel vs. placebo and paclitaxel among 409 women with recurrent platinum-resistant ovarian cancer.
Results showed median PFS of 5.29 months among women assigned to the ofra-vec group compared with 5.36 months among women in the paclitaxel control group (HR = 1.03). Median OS also did not differ significantly between the ofra-vec and control groups (13.37 months vs. 13.14 months; HR = 0.97).
“Given the urgent unmet need for those fighting platinum-resistant ovarian cancer, we are deeply disappointed that the topline data indicate that ofra-vec did not improve progression-free survival or overall survival,” Professor Dror Harats, MD, CEO of VBL Therapeutics, said in a press release. “Based on this outcome, we plan to discontinue the OVAL trial and will review the data from our ongoing phase 2 trials in metastatic colorectal cancer and recurrent glioblastoma multiforme to determine next steps with the ofra-vec program. We extend our deepest gratitude to all the patients, families and health care professionals who participated in this trial.”
References:
- VBL Therapeutics announces top-line data from phase 3 OVAL trial of ofra-vec in patients with platinum-resistant ovarian cancer (press release). Available at: ir.vblrx.com/news-releases/news-release-details/vbl-therapeutics-announces-top-line-data-phase-3-oval-trial-ofra. Published July 19, 2022. Accessed July 20, 2022.
- VBL Therapeutics. About us. www.vblrx.com/about. Accessed July 20, 2022.
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