VBL Therapeutics has successfully administered the initial dose to the first patient in its Phase 3 trial investigating the effects of VB-111 (ofranergene obadenovec) in platinum-resistant ovarian cancer.
The pivotal OVAL trial (NCT03398655), currently recruiting adult patients, will compare the effectiveness of VB-111 and Taxol (paclitaxel) against Taxol alone in women who failed to respond to prior platinum-based chemotherapy.
The trial is expected to enroll 350 patients from 70 clinical sites in the United States and Israel. For more information, click on the clinical trial registration number above.
VB-111 is a first-in-class anticancer agent that targets tumors through a dual mechanism. In addition to delivering a gene therapy that eliminates a tumor’s blood supply, the viral vector where the gene is inserted induces specific immune responses that lead to cancer cell death.
OVAL’s primary goal is to determine whether the addition of VB-111 to Taxol improves patients’ overall survival. Additional (secondary) endpoints include the proportion of patients who respond to the treatment, and the time to disease progression or death. Patient-reported outcome measures will also be assessed.
In a previous Phase 1/2 trial, combining a therapeutic dose of VB-111 with chemotherapy significantly increased survival times, compared to a low VB-111 dose – 810 days vs. 172 days.
Also, VB-111 reduced the levels of CA-125 – a marker for the disease – in 60 percent of patients in the trial, which nearly doubled the response rates seen in ovarian cancer patients treated with the standard of care – Avastin (bevacizumab) plus chemotherapy.
The OVAL trial is being conducted in collaboration with the nonprofit Gynecologic Oncology Group (GOG) Foundation, which promotes excellence in clinical research into different types of cancers.
“There is a tremendous need for effective treatments for women with platinum resistant and refractory ovarian cancer, estimated at 50,000 cases in the United States, for whom therapeutic options often fail to prolong survival,” Dror Harats, MD, CEO of VBL Therapeutics, said in a press release.
“We are excited to be working with the GOG, a standard-setting organization for clinical research on pelvic malignancies, in addressing this important medical need,” Harats added.
Richard Penson, MD, MRCP, principal investigator of the OVAL study, said GOG is dedicated to clinical research in gynecologic cancers.
“Interest in the VB-111 development program is based on positive clinical data generated using this agent, including the Phase 2 study that VBL completed in ovarian cancer, which showed a high response rate and better survival with the therapeutic dose of VB-111,” said Penson, an associate professor of medicine at Harvard Medical School and clinical director of Medical Gynecologic Oncology at Massachusetts General Hospital.
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