Genelux Announces Alignment with FDA on Key Elements of the Approval Pathway for Olvi-Vec in Platinum Resistant/Refractory Disease
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Currently, Olvi-Vec is being evaluated in the OnPrime/GOG-3076 Phase 3 registrational trial in
In response to a question seeking the FDA’s guidance on their expectations regarding a confirmatory trial using the ongoing OnPrime/GOG-3076 trial, the FDA responded that “As stated previously, an interim analysis of overall survival (OS) should be planned at the time of the primary PFS analysis. If a clinically meaningful PFS advantage is demonstrated in the absence of a decrement in OS, this could potentially support traditional approval.” The FDA further recommended
“We appreciate the feedback from the FDA regarding our clinical strategy for OnPrime/GOG-3076 and the plan for submission of an eventual marketing application, which could avoid the need for conducting a separate confirmatory study if the clinically meaningful PFS advantage is demonstrated,” stated
About the OnPrime/GOG-3076 Trial
OnPrime/GOG-3076, a multi-center, randomized, open-label Phase 3 registrational trial evaluating the efficacy and safety of Olvi-Vec in combination platinum-doublet + bevacizumab compared with physician's choice of chemotherapy and bevacizumab in patients with PRROC. The trial is enrolling patients who are platinum resistant/refractory by standard definitions and received a minimum of 3 prior lines of therapy. The experimental arm patients receive a single cycle (two doses) of Olvi-Vec administered intraperitoneally and, approximately four weeks later, a regimen of a platinum-based doublet plus bevacizumab followed by maintenance therapy. The active comparator arm patients receive a regimen of single agent chemotherapy with optional platinum, plus bevacizumab followed by maintenance therapy. The trial will enroll a sufficient number of patients to achieve 127 events, with the primary endpoint of progression free survival and with secondary endpoints including overall survival.
The trial is designed to address a broad and underserved pool of ovarian cancer patients with no approved standard of care therapies. The inclusion criteria allows patients to enroll regardless of (i) tumor biomarkers, (ii) platinum refractory tumors or (iii) the maximum number of prior lines of treatments (i.e., no cap on previous treatments).
About Olvi-Vec
Olvi-Vec (olvimulogene nanivacirepvec), Genelux’s most advanced product candidate is a proprietary, modified oncolytic vaccinia virus, a stable DNA virus with a large engineering capacity. Genelux is developing Olvi-Vec for the treatment of multiple types of cancer based on the results of preclinical studies that suggest Olvi-Vec has the potential to infect and directly kill a wide range of tumor cell types in vitro and in vivo and produce an anti-tumor immune response.
About
Genelux is a late-stage clinical biopharmaceutical company focused on developing a pipeline of next-generation oncolytic immunotherapies for patients suffering from aggressive and/or difficult-to-treat solid tumor types. In addition to OnPrime/GOG-3076, Olvi-Vec currently is being evaluated in two clinical studies designed to demonstrated the ability to induce platinum resensitization via systemic administration: VIRO-25, a
Forward-Looking Statements
This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “believes,” “anticipates,” “expect,” “may,” “plan” or “will”. Forward-looking statements in this release include, but are not limited to, the potential regulatory approval pathway; the submission of a marketing application; capabilities, advantages, safety and efficacy of Olvi-Vec to treat platinum resistant/refractory ovarian cancer; and the Company’s expectations regarding the timing and availability of data. Such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements. These and other risks are identified under the caption “Risk Factors” in Genelux’s filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Genelux does not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise.
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Source: Genelux Corporation