Ovarian cancer patients wanted for Phase 3 trial of virus therapy
Study tests Olvi-Vec in patients with hard-to-treat cancer
A Phase 3 clinical trial testing the experimental cancer-killing virus Olvi-Vec in people with hard-to-treat ovarian cancer is recruiting participants.
Top-line results from the ongoing study are expected early next year, according to a corporate update from Genelux, the company developing Olvi-Vec and sponsoring the trial.
Ovarian cancer is a type of gynecological cancer that develops around the ovaries. Typical first-line treatment involves platinum-based chemotherapy, but some patients are relapsed or refractory to platinum chemotherapy — meaning the tumor either doesn’t respond or comes back after initially responding.
Olvi-Vec is a modified version of a virus called vaccinia, which is best known for being used to develop the smallpox vaccine. The vaccinia virus is similar to smallpox, but far less harmful. Olvi-Vec uses a version of the virus that’s been engineered so it will infect and kill cancer cells without infecting the body’s healthy cells.
“With important data milestones on the horizon, Olvi-Vec holds the potential to redefine the treatment paradigms of recurrent tumors in multiple indications, as well as the broader field of oncolytic immunotherapy,” said Thomas Zindrick, chairman, president, and CEO of Genelux.
A one-two punch to cancer cells
The viral therapy aims to attack tumors with a one-two punch: First, the virus itself destroys some tumor cells. When cells are being destroyed by a virus, signals are released to alert the immune system of the potential threat. Olvi-Vec aims to exploit this immune activation to guide the immune system to attack and kill cancer cells that are still alive following the initial infection.
The Phase 3 OnPrime/GOG-3076 (NCT05281471) study is testing Olvi-Vec in adults with ovarian cancer, including those with fallopian tube and primary peritoneal cancer, that is resistant or refractory to platinum chemotherapy. The study aims to enroll about 186 patients who have received at least three prior lines of therapy. Recruitment is ongoing at 31 sites across the U.S.
All participants in the Phase 3 study will be given their physician’s choice of chemotherapy in addition to the approved anticancer medication bevacizumab (sold as Avastin, among others). Some of the participants also will be treated with Olvi-Vec, given directly into the abdominal cavity, while others will not. The study’s main goal is to see if the addition of Olvi-Vec delays the time to disease progression or death for up to a year of follow-up.
The Phase 2 VIRO-15 (NCT02759588) study showed that the treatment worked well and was safe for patients with platinum-resistant ovarian cancer. Many of these patients had tried multiple treatments. Delivering the therapy directly into the abdominal cavity effectively killed cancer cells, activated the immune system, and in some cases made the cancer cells respond to platinum drugs again.
Genelux is also developing the therapy as a potential treatment for certain forms of lung cancer, with clinical trials ongoing.
“We are entering an exciting phase of growth as we work to advance a potentially transformative therapy for patients with limited treatment options,” Zindrick said.
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