Genelux Announces Alignment with FDA on Key Elements of the Approval Pathway for Olvi-Vec in Platinum Resistant/Refractory Disease
Genelux (NASDAQ: GNLX) has announced a successful Type D meeting with the FDA regarding Olvi-Vec's approval pathway for treating platinum resistant/refractory ovarian cancer (PRROC). The FDA indicated that data from the ongoing OnPrime/GOG-3076 Phase 3 registrational trial could potentially support traditional approval without requiring a separate confirmatory study.
The FDA specified that if the trial demonstrates a clinically meaningful progression-free survival (PFS) advantage without decreasing overall survival (OS), it could be sufficient for traditional approval. The company plans to report topline safety and efficacy data in the first half of 2026.
Genelux (NASDAQ: GNLX) ha annunciato un incontro di successo di Tipo D con la FDA riguardo al percorso di approvazione di Olvi-Vec per il trattamento del cancro ovarico resistente/refrattario al platino (PRROC). La FDA ha indicato che i dati provenienti dall'attuale OnPrime/GOG-3076 studio registrativo di Fase 3 potrebbero potenzialmente supportare un'approvazione tradizionale senza richiedere uno studio di conferma separato.
La FDA ha specificato che se lo studio dimostra un vantaggio clinicamente significativo nella sopravvivenza libera da progressione (PFS) senza ridurre la sopravvivenza globale (OS), ciò potrebbe essere sufficiente per un'approvazione tradizionale. L'azienda prevede di riportare i dati preliminari di sicurezza ed efficacia nella prima metà del 2026.
Genelux (NASDAQ: GNLX) ha anunciado una reunión exitosa de Tipo D con la FDA sobre la vía de aprobación de Olvi-Vec para el tratamiento del cáncer de ovario resistente/refractario al platino (PRROC). La FDA indicó que los datos del ensayo registrativo de Fase 3 OnPrime/GOG-3076 en curso podrían potencialmente respaldar una aprobación tradicional sin requerir un estudio de confirmación separado.
La FDA especificó que si el ensayo demuestra una ventaja clínicamente significativa en la supervivencia libre de progresión (PFS) sin disminuir la supervivencia global (OS), podría ser suficiente para una aprobación tradicional. La compañía planea informar sobre los datos preliminares de seguridad y eficacia en la primera mitad de 2026.
Genelux (NASDAQ: GNLX)는 FDA와의 성공적인 D형 회의를 통해 Olvi-Vec의 백금 저항성/내성 난소암(PRROC) 치료를 위한 승인 경로에 대해 발표했습니다. FDA는 진행 중인 OnPrime/GOG-3076 3상 등록 시험의 데이터가 별도의 확인 연구 없이도 전통적인 승인을 지원할 수 있다고 밝혔습니다.
FDA는 시험이 전반적인 생존(OS)을 감소시키지 않으면서 임상적으로 의미 있는 무진행 생존(PFS) 이점을 입증할 경우, 전통적인 승인을 위한 충분한 근거가 될 수 있다고 명시했습니다. 회사는 2026년 상반기에 안전성과 효능에 대한 주요 데이터를 보고할 계획입니다.
Genelux (NASDAQ: GNLX) a annoncé une réunion de type D réussie avec la FDA concernant le chemin d'approbation d'Olvi-Vec pour le traitement du cancer de l'ovaire résistant/réfractaire au platine (PRROC). La FDA a indiqué que les données de l'essai d'enregistrement de Phase 3 OnPrime/GOG-3076 en cours pourraient potentiellement soutenir une approbation traditionnelle sans nécessiter une étude de confirmation séparée.
La FDA a précisé que si l'essai démontre un avantage cliniquement significatif en termes de survie sans progression (PFS) sans réduire la survie globale (OS), cela pourrait être suffisant pour une approbation traditionnelle. L'entreprise prévoit de communiquer des données préliminaires sur la sécurité et l'efficacité dans la première moitié de 2026.
Genelux (NASDAQ: GNLX) hat ein erfolgreiches Type-D-Meeting mit der FDA bezüglich des Genehmigungswegs von Olvi-Vec zur Behandlung von platinresistentem/refraktärem Eierstockkrebs (PRROC) bekannt gegeben. Die FDA gab an, dass Daten aus der laufenden OnPrime/GOG-3076 Phase-3-Registrierungsstudie potenziell eine traditionelle Genehmigung unterstützen könnten, ohne dass eine separate Bestätigungsstudie erforderlich ist.
Die FDA spezifizierte, dass, wenn die Studie einen klinisch signifikanten Vorteil in der progressionsfreien Überlebenszeit (PFS) ohne Verringerung der Gesamtüberlebenszeit (OS) zeigt, dies für eine traditionelle Genehmigung ausreichend sein könnte. Das Unternehmen plant, in der ersten Hälfte von 2026 vorläufige Sicherheits- und Wirksamkeitsdaten zu berichten.
- FDA indicates potential traditional approval pathway without requiring separate confirmatory study
- Clear regulatory guidance received for approval requirements
- Phase 3 trial already ongoing with defined endpoints
- Topline data not expected until first half of 2026
- Approval still contingent on demonstrating meaningful PFS advantage
Insights
The FDA's feedback to Genelux represents a significant regulatory milestone for their lead candidate Olvi-Vec in platinum-resistant/refractory ovarian cancer. The agency's statement that the ongoing OnPrime/GOG-3076 Phase 3 trial could potentially support traditional approval (rather than accelerated approval) without requiring a separate confirmatory study is particularly noteworthy.
This guidance effectively streamlines the regulatory pathway in two critical ways: First, by potentially eliminating the need for an additional confirmatory trial, which typically adds years to development timelines and costs millions in additional expenses; Second, by providing clear metrics for approval - demonstrating a clinically meaningful progression-free survival advantage without negatively impacting overall survival.
For context, the FDA often requires companies to conduct separate confirmatory trials to verify clinical benefit, especially in oncology. This guidance suggests the agency views the current trial design as potentially robust enough to stand alone for approval consideration if it meets its endpoints.
For Genelux, a company with a
The FDA's feedback on Genelux's Olvi-Vec approval pathway addresses a critical area of unmet medical need in ovarian cancer treatment. Platinum-resistant/refractory ovarian cancer (PRROC) represents one of the most challenging treatment scenarios in gynecologic oncology, with effective options currently available.
The regulatory guidance focuses specifically on progression-free survival (PFS) as the primary endpoint of the OnPrime/GOG-3076 trial, with the important caveat that it should not come at the expense of overall survival (OS). This balanced approach reflects the evolving regulatory perspective on surrogate endpoints in oncology trials, where PFS can be acceptable if it represents meaningful clinical benefit without compromising survival.
What makes this update particularly important is the trial's connection to the Gynecologic Oncology Group (GOG), as indicated by the GOG-3076 designation. GOG-sponsored trials typically adhere to rigorous methodological standards and carry significant weight with regulators and clinicians alike.
The company's timeline projection for topline data in H1 2026 provides a clear milestone for evaluating Olvi-Vec's potential. If successful, this approach could potentially bring a new therapeutic option to patients with PRROC approximately 12-18 months faster than if a separate confirmatory trial were required, representing a meaningful acceleration in addressing this urgent medical need.
- U.S. Food and Drug Administration states that data from the ongoing OnPrime/GOG-3076 Phase 3 registrational trial could potentially support traditional approval -
WESTLAKE VILLAGE, Calif., March 25, 2025 (GLOBE NEWSWIRE) -- Genelux Corporation (NASDAQ: GNLX), a late clinical-stage immuno-oncology company, today announced that Genelux has concluded a productive Type D meeting with the U.S. Food and Drug Administration (FDA) for Olvi-Vec in the treatment of platinum resistant/refractory ovarian cancer (PRROC).
Currently, Olvi-Vec is being evaluated in the OnPrime/GOG-3076 Phase 3 registrational trial in the United States, with the primary endpoint of progression free survival (Clinicaltrials.gov identifier NCT05281471). The purpose of the FDA meeting was to discuss the FDA’s expectations with respect to the requirements necessary for the granting of traditional approval of Olvi-Vec.
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 Genelux request a pre-BLA meeting with FDA with topline safety and efficacy data following completion of the study to discuss next steps.
“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 Thomas Zindrick, President and CEO. “The FDA’s guidance regarding their expectations for the ongoing trial represents a significant milestone as we look forward to reporting topline safety and efficacy data in the first half of 2026. We remain committed to advancing a therapeutic option with the potential to provide a significant benefit for individuals living with PRROC, whose critical unmet need for innovative treatments is urgent.”
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. Genelux granted Newsoara an exclusive license to develop and commercialize Olvi-Vec in greater China (i.e., Mainland China, Hong Kong, Macau and Taiwan). To date, Olvi-Vec has been administered to more than 150 patients in seven completed clinical trials. In these trials, Olvi-Vec was observed to be generally well tolerated with data demonstrating clinical benefit. Olvi-Vec has been granted Fast Track designation by the US FDA for the treatment of platinum resistant/refractory ovarian cancer.
About Genelux Corporation
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 U.S.-based multi-center, randomized, open-label Phase 2 trial evaluating the efficacy and safety of Olvi-Vec & Platinum-doublet + physician's choice of immune checkpoint inhibitor compared to docetaxel in non-small-cell lung cancer and in Olvi-Vec-SCLC-202, a Phase 1b/2, open-label, China-based multicenter clinical trial evaluating the safety, tolerability, pharmacokinetics and efficacy of intravenously delivered Olvi-Vec combined with platinum and etoposide in the treatment of platinum-relapsed or platinum-refractory extensive small cell lung cancer patients. The core of Genelux's discovery and development efforts revolves around its proprietary CHOICE™ platform from which the Company has developed an extensive library of isolated and engineered oncolytic vaccinia virus immunotherapeutic product candidates, including Olvi-Vec.
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.
Investor and Media Contacts
Ankit Bhargava, MD
Allele Communications, LLC
genelux@allelecomms.com
Source: Genelux Corporation
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