Genelux has commenced the Phase III clinical trial of its Olvimulogene Nanivacirepvec (Olvi-Vec), along with platinum-doublet plus bevacizumab, in platinum-resistant/refractory ovarian cancer (PRROC) patients.
Named OnPrime, the randomised, open-label, multicentre, registrational trial will assess the safety and efficacy of the combination treatment versus platinum-doublet plus bevacizumab.
The trial will be conducted at nearly 30 sites in the US as a partnership between the company and The Gynecological Oncological Group.
It will enrol 186 women, who will be categorised into a 2:1 ratio to receive Olvi-Vec and platinum-doublet plus bevacizumab in the experimental arm, or platinum-doublet plus bevacizumab in the active comparator arm.
Progression-free survival (PFS) based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as evaluated by a blinded independent central review is the trial’s primary endpoint.
The crucial secondary endpoints of the trial are overall response rate, overall survival, and safety.
A non-pathogenic oncolytic vaccinia virus, Olvi-Vec is modified to boost its tumour selectivity, safety, and treatment potential.
So far, it has been assessed in over 150 patients with various kinds of cancer in clinical trials.
In the Phase II VIRO-15 trial in PRROC patients, Olvi-Vec had met the efficacy and safety endpoints.
The median PFS was reported to be 11 months, with a 54% overall response rate (ORR), both by RECIST 1.1.
Genelux president and CEO Thomas Zindrick said: “Based on the positive results of our VIRO-15 Phase II trial, we believe that Olvi-Vec-primed immunochemotherapy has the potential to address the high unmet need of patients living with PRROC.
“Our goal in Phase III is to replicate these positive results and transform the treatment paradigm for this particularly difficult-to-treat cancer.”