Intravenous Olvi-Vec Yields Responses in NSCLC and SCLC Following Progression

Systemic intravenous administration of olvimulogene nanivacirepvec (Olvi-Vec) yielded positive preliminary results for patients with progressive non–small cell lung cancer (NSCLC) and progressive SCLC following progression on prior platinum-based regimens in 2 separate ongoing trials, according to a press release from the developer, Genelux Corporation.¹

The first trial generating results was the open-label, multicenter phase 1b/2 SCLC trial (NCT07136285), which evaluated intravenous Olvi-Vec in combination with platinum-based chemotherapy plus etoposide in patients with advanced SCLC who have platinum-recurrent or platinum-refractory disease. The second was the phase 2 VIRO-25 trial (NCT06463665), which evaluated Olvi-Vec followed by platinum doublet chemotherapy plus physician’s choice of an immune checkpoint inhibitor (ICI) compared with docetaxel in patients with NSCLC after first progression on frontline ICI-based maintenance.

“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.¹ “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.”

It was also reported that additional interim data readouts for both the SCLC and VIRO-25 trials are expected throughout 2026.

The SCLC Trial

In the SCLC trial, with a cutoff date of December 23, 2025, among 9 evaluable patients, the overall response rate (ORR) was 33%, with 3 patients achieving a partial response (PR). Notably, 2 of the 3 PRs, with tumor shrinkage of 55% and 85% from baseline, occurred in the highest-dose cohort.

The overall disease control rate (DCR) was 67%, with tumor shrinkage ranging from 24% to 85% observed in the 6 patients who achieved disease control.

Of the 3 patients who achieved PRs, 2 were evaluated in long-term follow-up. The first patient had received one prior line of therapy and, at their last scan, achieved a PR with a progression-free survival (PFS) of 12.1 months that remained ongoing. The second patient had received 4 prior lines of therapy and had a PFS of 7.7 months; notably, this PFS is greater than what the same patient experienced in the preceding line of therapy by 5.9 months, as they had a PFS of 1.9 months.

Regarding safety, Olvi-Vec was generally well tolerated.

Treatment in this trial consisted of Olvi-Vec administered for 3 days in cycle 1. Then, 21 days following the first dose of Olvi-Vec, platinum-based chemotherapy and etoposide were administered on days 1, 2, and 3 every 21 days until disease progression or intolerable toxicity.² The primary end point of the trial was the safety of Olvi-Vec. Secondary end points were dose-limiting toxicities, ORR, DCR, and PFS.

Patients enrolled in the trial were 18 years or older with SCLC who had received platinum-based chemotherapy regimens and/or immunotherapy and experienced progression or recurrence. They also had at least 1 measurable lesion, an ECOG performance status of 0 or 1, and sufficient bone marrow, liver, and kidney organ function.

The VIRO-25 Trial

With a data cutoff date of December 31, 2025, in the initial dose-escalation cohorts, 5 patients were evaluable. The DCR was 60%, and among the 3 patients to achieve disease control, the tumor size changes compared with baseline were 8.9%, –18.9%, and –22.7%.

It was also reported that Olvi-Vec was generally well tolerated.

Patients in the trial were randomly assigned, in a 1:1 ratio, to either the experimental arm or the active comparator arm.³ The experimental arm was broken into several cohorts with increasing doses of Olvi-Vec, which was administered from 0.5 x 10e9 plaque-forming units (PFU) to 3 x 10e9 PFU. Patients also received platinum doublet chemotherapy plus physician’s choice of ICI 2 to 3 weeks following Olvi-Vec. In the active comparator arm, patients received docetaxel per local practice until disease progression. Patients in the active comparator arm were permitted to cross over to the experimental arm after experiencing disease progression if they were eligible.

The trial enrolled patients 18 years or older with histologically or cytologically confirmed advanced or metastatic NSCLC with stage III or IV squamous or nonsquamous disease who had received at least 2 cycles and a maximum of 6 cycles of frontline platinum-based chemotherapy with ICI-based therapy and reached first disease progression while receiving frontline or maintenance ICI. Additionally, patients had an ECOG performance status of 0 or 1, at least 1 measurable target tumor lesion, and adequate renal, hepatic, and bone marrow function.

The trial’s primary end point was PFS per RECIST v1.1 by blinded independent central review. Secondary end points included ORR, overall survival, 6-month PFS, and safety.

References

1. Genelux Corporation reports encouraging interim data of systemic administration of Olvi-Vec in ongoing lung cancer trials. News release. Genelux Corporation. January 5, 2026. Accessed January 5, 2026. https://tinyurl.com/5n767huf
2. Olvi-Vec combined with platinum plus etoposide therapy in patients with late phase SCLC. ClinicalTrials.gov. Updated December 3, 2025. Accessed January 5, 2026. https://tinyurl.com/y4v3mk8t
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. Accessed January 5, 2026. https://tinyurl.com/yc37pvad