Top-line data reported for phase III OVAL trial of VB III (ofra-vec) in patients with platinum- resistant ovarian cancer.
VBL Therapeutics, announced top-line data from the Phase III OVAL clinical trial of ofra-vec (ofranergene obadenovec; VB-111) in platinum-resistant ovarian cancer.
The trial did not meet the primary endpoints of achieving a statistically significant improvement in progression-free survival (PFS) or overall survival (OS).
The OVAL trial demonstrated that patients randomized to the combination of ofra-vec and paclitaxel had a median PFS of 5.29 months, versus 5.36 months for the paclitaxel control arm (HR=1.03). The interim overall survival analysis was also not significantly different between the two study arms (median OS 13.37 months in the treatment arm versus 13.14 months in the control arm; HR= 0.97) and did not support study continuation.
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