FDA Grants FTD to Ofra-Vec Plus Paclitaxel for Platinum-Resistant Ovarian Cancer

The FDA has granted fast track designation to ofranergene obadenovec in combination with paclitaxel for the treatment of platinum-resistant ovarian cancer. The agent is under investigation in the phase 3 OVAL study.

The FDA has granted fast track designation to ofranergene obadenovec (ofra-vec or VB-111) in combination with paclitaxel for the treatment of platinum-resistant ovarian cancer, according to an announcement by VBL Therapeutics.1

Ofra-vec is an investigational anti-cancer, gene-therapy that is currently under investigation for the treatment of multiple solid tumors. The agent had already been granted orphan drug designation by the FDA for the treatment of malignant glioma and fast track designation for the treatment of recurrent glioblastoma multiforme and platinum-resistant ovarian cancer.

“We are pleased to receive FDA fast track desgnation for ofra-vec in platinum-resistant ovarian cancer. The Fast Track designation can facilitate the process towards potential registration and, importantly, may help expedite the time to market for ofra-vec, if approved,” said Dror Harats, MD, chief executive officer of VBL Therapeutics, in a press release.

The investigational combination of ofra-vec and paclitaxel is being compared with placebo and paclitaxel in adult patients with recurrent platinum-resistant ovarian cancer in the OVAL study. The phase 3 study has randomized, controlled, double-arm, double-blind, multicenter design. Approximately 400 patients will be included. Those enrolled in the ofra-vec arm will received an intravenous (IV) dose of the agent at 1 x10e13 VPs every 2 months with IV paclitaxel at 80 mg/m2 every week. In the placebo arm, patients will receive matching doses of placebo and paclitaxel.2

The coprimary end points of the OVAL study are overall survival (OS) and progression-free survival (PFS). The secondary end points include combined CA-125 and RECIST 1.1 response, CA-125 response, objective response rate, and OS100 for a sensitivity analysis of OS.

Female aged 18 years or older are eligible to enroll given they have histologically confirmed epithelial ovarian cancer and document disease. All patients are required to have platinum-resistant disease, measurable disease per RECIST 1.1 and in need of chemotherapy. Patients must also have an ECOG performance status of 0 or 1, and adequate hematological function. Those with a BRCA mutation are permitted only after failure on a PARP inhibitor, or if they are intolerant or ineligible for treatment with a PARP inhibitor.

In terms of prior treatment, patients are not permitted to enroll if they received ovarian cancer treatment with > 5 anticancer regimens or radiotherapy to the pelvis.

Other grounds for exclusion from the study include grade II or greater congestive heart failure, history of myocardial infarction, unstable angina, stroke, or hemoptysis or active gastrointestinal bleeding, of with 6 months of randomization in the study. In addition, patients with non-epithelial tumors ovarian tumor with low malignant potential, inadequate liver or renal function, vascular retinopathy, known brain metastases, an active malignancy within 5 years of enrollment, and other uncontrolled infections or conditions that may interfere with treatment are excluded from the study.

The study is being conducted at 94 locations across the United States, as well as in Israel, Japan, Poland, and Spain. Currently, locations are not recruiting patients.

“The readout of the progression free survival primary endpoint in the OVAL trial will be an important milestone for VBL in the second half of this year. We believe that, if positive, this will support a biologics license application submission to the FDA, said Harats, in a statement.1


1. VBL Therapeutics receives FDA fast track designation for ofra-vec for the treatment of platinum-resistant ovarian cancer. News release. April 26, 2022. Accessed April 26, 2022. https://bit.ly/3vCLKCc

2. A Study of VB-111 with paclitaxel vs paclitaxel for treatment of recurrent platinum-resistant ovarian cancer (OVAL). Clinicaltrials.gov. Updated March 22, 2022. Accessed April 26, 2022. https://bit.ly/3vMXwKn

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