Phase 1/2 Data Support Systemic Olvi-Vec in Lung Cancer

Encouraging interim data from 2 ongoing clinical trials evaluating the systemic intravenous (IV) administration of olvimulogene nanivacirepvec (Olvi-Vec) in patients with advanced lung cancer suggest that systemic delivery of this modified oncolytic vaccinia virus is feasible, well-tolerated, and capable of eliciting clinical responses in heavily pretreated populations.¹

The findings are derived from the phase 1b/2 OLVI-VEC-SCLC-202 trial² (NCT07136285) in small cell lung cancer (SCLC) and the phase 2 VIRO-25 trial³ (NCT06463665) in non–small cell lung cancer (NSCLC).

Efficacy Signals in SCLC and NSCLC

OLVI-VEC-SCLC-202 is evaluating Olvi-Vec in combination with platinum-based chemotherapy and etoposide for patients with platinum-relapsed or refractory SCLC. Early efficacy signals were observed across 9 evaluable patients. The overall response rate (ORR) was 33% (n = 3), and the disease control rate (DCR) reached 67% (n = 6).¹

Notably, a potential dose-response relationship emerged in the highest dose cohort (cohort 4), where the ORR was 67% (n = 2/3). Patients in this cohort experienced significant tumor shrinkage of approximately 55% and 85% from baseline. Durability signals were also noted; 1 patient with a partial response maintained progression-free survival (PFS) for 12.1 months, while another heavily pretreated patient (4 prior lines) achieved a PFS of 7.7 months, nearly 4 times the duration of their immediately preceding line of therapy.

VIRO-25 evaluates Olvi-Vec combined with platinum-doublet chemotherapy and an immune checkpoint inhibitor in patients with advanced or metastatic recurrent NSCLC. The interim DCR was 60% among 5 evaluable patients. These patients had all previously failed standard frontline platinum and immunotherapy regimens.

The interim analysis focuses on the transition of Olvi-Vec from localized regional administration—previously studied in ovarian cancer—to a systemic dosing regimen intended to support future multiregional registrational trials.

“We are encouraged by the emerging data from our lung cancer programs, where systemically delivered Olvi-Vec continues to demonstrate promising antitumor activity and tolerability in patients with relapsed or refractory lung cancers,” said Thomas Zindrick, president, CEO, and chairman of Genelux, in a news release. “While these data remain preliminary, they reinforce our commitment to advancing 2 registration-path trials in progressive lung cancers, addressing a significant unmet medical need and building on our success in platinum-resistant/refractory ovarian cancer. We remain focused on establishing Olvi-Vec as a differentiated immunotherapeutic agent designed to modify the tumor microenvironment and resensitize tumors to platinum-based chemotherapy across multiple types of cancer.”

Safety and Mechanism of Action

The safety profile of systemically administered Olvi-Vec remained consistent with earlier studies of the agent. Most treatment-emergent adverse events were grade 1 or 2, primarily consisting of transient flu-like symptoms such as fever and chills, which are characteristic of viral-induced immune activation. No dose-limiting toxicities were reported in the systemic cohorts to date.

Pharmacodynamic assessments confirmed the successful delivery of the viral payload to tumor sites. Biopsies and blood analyses demonstrated viral DNA presence and evidence of viral replication within the tumor microenvironment following IV infusion. This replication is thought to trigger immunogenic cell death, potentially resensitizing tumors to subsequent chemotherapy and checkpoint inhibition, a mechanism previously hypothesized in the phase 2 VIRO-15 trial (NCT02759588).⁴

“Looking ahead, 2026 will be a pivotal year with topline data from the phase 3 registration trial in ovarian cancer [OnPrime/GOG-3076 trial (NCT05281471)]⁵ expected in the second half and additional lung cancer trial readouts anticipated throughout the year,” added Zindrick in the news release.¹

REFERENCES

1. Genelux Corporation reports encouraging interim data of systemic administration of Olvi-Vec in ongoing lung cancer trials. News release. January 5, 2026. Accessed January 7, 2026. https://tinyurl.com/565mywa7

2. Olvi-vec combined with platinum plus etoposide therapy in patients with late phase SCLC. ClinicalTrials.gov. Updated December 3, 2025. Accessed January 7, 2026. https://clinicaltrials.gov/study/NCT07136285

3. Efficacy & safety of olvimulogene nanivacirepvec & platinum-doublet + physician's choice of immune checkpoint inhibitor compared to docetaxel in NSCL cancer (VIRO-25). ClinicalTrials.gov. Updated September 26, 2025. Accesed January 7, 2026. https://clinicaltrials.gov/study/NCT06463665

4. Holloway RW, Mendivil AA, Kendrick JE, et al. Clinical activity of olvimulogene nanivacirepvec-primed immunochemotherapy in heavily pretreated patients with platinum-resistant or platinum-refractory ovarian cancer: the nonrandomized phase 2 VIRO-15 clinical trial. JAMA Oncol. 2023 Jul 1;9(7):903-908. doi: 10.1001/jamaoncol.2023.1007. PMID: 37227734; PMCID: PMC10214174.

5. Efficacy & safety of olvi-vec and platinum-doublet + bevacizumab compared to physician's choice of chemotherapy and bevacizumab in platinum-resistant/​refractory ovarian cancer (PRROC) (OnPrime, GOG-3076). ClinicalTrials.gov. Updated November 5, 2026. Accessed January 7, 2026. https://www.clinicaltrials.gov/study/NCT05281471