Gene therapy for ovarian cancer fails PhIII study — sinking biotech's shares
Despite promising interim results, VBL Therapeutics’ ovarian cancer drug has ultimately flopped in a Phase III trial.
The Nasdaq-listed Israeli biotech revealed that the OVAL trial of ofranergene obadenovec (also known as ofra-vec, or VB-111) did not meet the primary endpoints of improving upon progression-free survival or overall survival.
“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,” CEO Dror Harats said in a statement.
VBL shares $VBLT plummeted almost 79% to $0.44, making it officially a penny stock.
A gene therapy manufactured with a replication deficient adenovirus 5, ofra-vec is described to have a dual mechanism of action — both cutting off the blood supply to the tumor and inciting an immune response against the tumor.
The Phase III OVAL trial tested the drug among women with recurrent, platinum-resistant ovarian cancer.
Topline data suggested that the paclitaxel plus placebo control arm did slightly better on PFS, with a median PFS of 5.36 months versus the group that received a combination of ofra-vec and paclitaxel, who saw a median PFS of 5.29 months.
In the interim OS analysis, investigators said the two study arms were not significantly different: the treatment arm had a median OS of 13.37 months versus 13.14 months in the control arm.
VBL had provided a couple of data snapshots leading up to the latest readout, both of which it said supported continuation of the trial. The Data Safety Monitoring Committee looked at CA-125 response in the first analysis while the second centered around OS rate.