Genelux Corporation Initiates a Pivotal Phase 3 Trial, Evaluating Olvi-Vec for the treatment of Platinum-Resistant/Refractory Ovarian Cancer
WESTLAKE VILLAGE, Calif., Sept. 21, 2022 (GLOBE NEWSWIRE) -- Genelux Corporation, a clinical-stage immunotherapy company, announced today that it has initiated OnPrime, a multi-center, randomized, open-label Phase 3 registrational trial evaluating the efficacy and safety of Olvi-Vec in combination with platinum-doublet + bevacizumab compared to platinum-doublet + bevacizumab in patients with platinum-resistant/refractory ovarian cancer (PRROC).
OnPrime is a US-based trial that will be conducted at approximately 30 sites across the country and has a planned enrollment of 186 women with PRROC, randomized 2:1 into an Experimental Arm of Olvi-Vec and platinum-doublet + bevacizumab and an Active Comparator Arm of platinum-doublet + bevacizumab.
“Initiating the OnPrime trial represents a major milestone for Genelux,” said Thomas D. Zindrick, President and CEO, Genelux. “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 PRROC. Our goal in Phase 3 is to replicate these positive results and transform the treatment paradigm for this particularly difficult-to-treat cancer. We look forward to progressing our study and sharing updates on the Olvi-Vec clinical development program.”
To date, Olvi-Vec has been studied in multiple early- and mid-phase clinical trials via regional, local and systemic deliveries, as a monotherapy and in combination with other therapies, in approximately 150 patients with a variety of cancer types. In the VIRO-15 Phase 2 trial, twenty-seven PRROC patients with a median of four prior lines and disease progressed after the last prior line, were enrolled. Olvi-Vec met the pre-established efficacy and safety endpoints as shown in data presented in an Oral Plenary Session at the International Gynecologic Cancer Society 2020 Annual Global Meeting. Median progression-free survival by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 was 11.0 months (95% CI, 6.7-13.0 months), overall response rate (ORR) by RECIST1.1 was 54%, and ORR by GCIG CA-125 was 85%. The most frequent grade 3 treatment-related adverse event was abdominal pain (7.4%), with no observed treatment-related discontinuations or patient deaths. Our clinical trials have yielded data that has informed future clinical strategy and trial design involving multiple indications and methods of delivery.
OnPrime Study eligibility: Eligible patients will have a minimum of 3 prior lines of therapy, but there is no limitation on the maximal number of prior therapies. The primary endpoint is progression-free survival based on RECIST 1.1 as assessed by a blinded independent cntral review, with overall response rate, overall survival and safety as key secondary endpoints.
About Platinum-Resistant/Refractory Ovarian Cancer
1Surveillance, Epidemiology, and End Results Program (SEER) database, 2019
About Olvimulogene Nanivacirepvec (Olvi-Vec)
About Genelux Corporation
About The GOG Foundation, Inc. (www.gog.org)
The GOG Partners, a GOG Foundation program, is structured to work directly with pharmaceutical organizations and operate clinical trials outside the National Cancer Institute (NCI) framework. The GOG Partners shares the same mission of the GOG Foundation dedicated to transforming the care in Gynecologic Oncology. By providing an alternative venue for patient accrual and site infrastructure support, GOG Partners has helped provide additional trials and opportunities for patients outside the national gynecologic clinical trials network.