Phase 3 Trial to Study an Immunochemotherapy Regimen in Platinum-Resistant/Refractory Ovarian Cancer

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The OnPrime trial will investigate if adding Olvi-Vec, a modified virus, to chemotherapy and Avastin will improve outcomes for pretreated platinum-resistant or refractory ovarian cancer.

A phase 3 clinical trial is launching in 30 sites across the country, testing an Olvi-Vec—containing regimen in patients with platinum-resistant or refractory ovarian cancer, according to the Genelux Corporation, the manufacturer of Olvi-Vec.

Researchers plan on enrolling 186 patients into the OnPrime trial, who will be randomly assigned to a treatment group. Two-thirds of patients will be prescribed Olvi-Vec plus platinum-doublet chemotherapy plus Avastin (bevacizumab), while the other third of patients will receive the platinum doublet plus Avastin, without Olvi-Vec.

Olvi-Vec, a vaccinia virus, previously demonstrated promising results in the phase 2 VIRO-15 trial. The drug met its pre-established safety and efficacy goals, and results showed that on average, patients given Olvi-Vec lived for 11 months before their disease worsened (a datapoint known as progression-free survival), with 54% of patients experiencing disease shrinkage from the drug (overall response rate). Additionally, the overall response rate was 85%.

“Based on the positive results of our VIRO-15 phase 2 trial, we believe that Olvi-Vec-primed immunochemotherapy has the potential to address the high unmet need of patients living with (platinum-resistant, refractory ovarian cancer),” said Thomas D. Zindrick, president and CEO of Genelux, in a company-issued press release.

Now, to be eligible for OnPrime, patients must have platinum-resistant or refractory ovarian cancer that was treated with at least three lines of prior therapy.

The goal of the trial is to see if the Olvi-Vec regimen elicits improved progression-free survival compared to those who did not receive the drug. The researchers will also assess overall response rate, overall survival (average time from treatment until death of any cause) and safety.

“Our goal in phase 3 is to replicate these positive results and transform the treatment paradigm for this particularly difficult-to-treat cancer,” Zindrick concluded.

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