Olvi-Vec Shows Early Activity in Small Cell and NSCLC Trials

Interim clinical trial results suggest that the investigational therapy Olvi-Vec may provide benefit for some patients with advanced lung cancer whose disease progressed after standard platinum-based treatment. The data, which were announced by the Genelux Corporation on Jan. 05, 2026, come from two ongoing studies evaluating Olvi-Vec given intravenously (through an IV) in patients with small cell lung cancer and non-small cell lung cancer in China and the United States.

Olvi-Vec is an oncolytic immunotherapy designed to kill cancer cells directly, stimulate an immune response and modify the tumor microenvironment. Researchers are studying whether this approach can help make tumors sensitive again to platinum-based chemotherapy, which is commonly used to treat lung cancer but often stops working after disease progression.

“We are encouraged by the emerging data from our lung cancer programs, where systemically delivered Olvi-Vec continues to demonstrate promising anti-tumor activity and tolerability in patients with relapsed or refractory lung cancers,” Thomas Zindrick, president, CEO, and chairman of Genelux, said in the news release.

Main Data That Support the Findings

In a phase 1b/2 study enrolling patients with platinum-relapsed or platinum-refractory small cell lung cancer, early data showed tumor shrinkage and disease control in several participants. As of the Dec. 23, 2025, data cutoff, nine patients were evaluable for response. Three patients experienced partial responses, resulting in an overall response rate of 33%.

Two of the three partial responses occurred in the highest dose group tested at the time of analysis. Tumor shrinkage in those patients was approximately 55% and 85% from baseline, suggesting a possible dose-related effect. Overall, six of the nine patients achieved disease control, meaning their cancer either shrank or remained stable. All six experienced reductions in their target lesions compared with baseline measurements.

Investigators also observed early signs that some responses may be durable. One patient with one prior line of therapy had an ongoing progression-free survival of 12.1 months at the time of the most recent scan. Another patient, who had received four prior lines of treatment, experienced progression-free survival of 7.7 months, compared with 1.9 months on the patient’s most recent previous therapy.

In the phase 2 VIRO-25 study enrolling patients with advanced or metastatic recurrent non-small cell lung cancer, early anti-tumor activity was also observed. As of the Dec. 31, 2025, data cutoff, five patients were evaluable for response. Three patients achieved disease control, resulting in a disease control rate of 60%. Tumor size changes among those patients ranged from slight growth to reductions of nearly 23% compared with baseline.

“While these data remain preliminary, they reinforce our commitment to advancing two registration-path trials in progressive lung cancers, addressing a significant unmet medical need and building on our success in platinum-resistant/refractory ovarian cancer,” Zindrick continued. “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. Looking ahead, 2026 will be a pivotal year with topline data from the phase 3 registration trial in ovarian cancer expected in the second half and additional lung cancer trial readouts anticipated throughout the year.”

Olvi-Vec Trial Details

The phase 1b/2 small cell lung cancer trial is an open-label study evaluating a single intravenous cycle of Olvi-Vec given in multiple doses in combination with platinum and etoposide chemotherapy. The trial enrolls patients whose disease progressed after prior treatment with platinum and etoposide and is being conducted in China by Genelux’s licensing partner, Newsoara HYK Biopharmaceuticals Co., Ltd. The primary goals of the study are to assess safety and tolerability while identifying an appropriate dose for future trials.

The phase 2 VIRO-25 trial is an open-label study enrolling patients with advanced or metastatic recurrent non-small cell lung cancer in the United States. Participants previously received standard frontline treatment with platinum chemotherapy and an immune checkpoint inhibitor. In this study, Olvi-Vec is administered intravenously in combination with platinum chemotherapy and an immune checkpoint inhibitor.

Together, the studies are designed to determine whether Olvi-Vec can be effectively delivered systemically, rather than locally, which could support its development across multiple solid tumor types.

Understanding the Safety of Olvi-Vec

Across both trials, Olvi-Vec was generally well tolerated. In the small cell lung cancer study, patients who experienced tumor responses did not receive maintenance immunotherapy following treatment, as the trial is primarily focused on safety and dose escalation. No new safety concerns were reported in either study as of the respective data cutoff dates.

Both trials remain ongoing, with continued enrollment in dose-escalation cohorts aimed at optimizing efficacy, safety and tolerability. Genelux expects to report additional interim lung cancer data throughout 2026, along with topline results later this year from a phase 3 trial evaluating Olvi-Vec in patients with platinum-resistant or platinum-refractory ovarian cancer.

Reference

1. “Genelux Corporation Reports Encouraging Interim Data of Systemic Administration of Olvi-Vec in Ongoing Lung Cancer Trials,” News Release. Genelux Corporation. Jan. 05, 2026.

Editor's note: This article is for informational purposes only and is not a substitute for professional medical advice, as your own experience will be unique. Use this article to guide discussions with your oncologist. Content was generated with AI, reviewed by a human editor, but not independently verified by a medical professional.

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