Olvi-Vec Exhibits Preliminary Efficacy in Advanced Small Cell Lung Cancer

Among 7 patients with documented disease progression at baseline treated with olvi-vec, the disease control rate was 71% (5/7), with 2 patients achieving a partial response.

Olvi-vec immunochemotherapy exhibited preliminary efficacy in a small cohort of patients with platinum-relapsed or platinum-refractory extensive-small cell lung cancer (ES-SCLC), according to a news release from the drug’s developer, Genelux.

At the data cut-off date of February 19, 2025, findings from the phase 1b/2 OLVI-VEC-SCLC-202 study revealed that among 7 patients with documented disease progression at baseline treated with olvi-vec, the disease control rate (DCR) was 71% (5/7), with 2 patients achieving a partial response. Additionally, all patients who experienced disease control had a reduction in all target lesions, with 1 patient achieving an approximate tumor reduction rate of 79%.

Further data showed that 3 patients attained disease control at lower doses of olvi-vec, including 1 who received 3 prior lines of treatment. Tumor reduction sizes among these patients ranged from 24% to 29.2%.

“We are encouraged by the phase 1b trial data which suggests preliminary anti-tumor activity [in ES-SCLC]. Consistent reductions in all individual target lesions in [patients] experiencing disease control, combined with encouraging anti-tumor activity of the first evaluable [patient] in the most recent dose-escalation cohort, highlights the potential of systemically administered olvi-vec to provide meaningful clinical benefit for patients with relapsed or refractory [ES-SCLC],” Thomas Zindrick, president, chief executive officer, and chairman of Genelux, said in the news release. “These results are consistent with our previous phase 2 results in platinum-resistant/refractory ovarian cancer and, with further investigation in our ongoing trials in relapsed/refractory lung cancer, we anticipate demonstrating the potential of olvi-vec as a platinum resensitizing immunotherapeutic agent across multiple types of recurrent cancers with significant unmet medical needs.”

The open-label, multicenter phase 1b/2 Olvi-Vec-SCLC-202 study enrolled patients with platinum-relapsed or platinum-refractory ES-SCLC to receive olvi-vec treatment. Patients received olvi-vec treatment for 3 consecutive days as a single cycle followed by platinum chemotherapy plus etoposide 21 days after olvi-vec dosing until disease progression or unacceptable toxicity.

The phase 1b trial is enrolling patients in China at Shanghai Crest Hospital and Zhejiang Provincial People’s Hospital and is evaluating the safety, tolerability, pharmacokinetics, and efficacy of intravenous olvi-vec plus platinum chemotherapy and etoposide. The dose-escalation portion of the trial is assessing the recommended dose and dosing regimen of olvi-vec for phase 2 expansion based on the safety and tolerability of increasing doses of the investigational agent.

Safety data may undergo evaluation to support the safe combination of olvi-vec with other agents to enhance the depth and durability of phase 2 responses. The phase 2 portion of the trial will further evaluate the safety, tolerability, and efficacy of olvi-vec at the recommended phase 2 dose.

According to the news release, olvi-vec delivered intravenously exhibited a manageable safety and tolerability profile, consistent with historical data found in other clinical trials of the investigational therapy. Treatment-related adverse effects were mild to moderate in severity, the most common of which included fever, anemia, reduced lymphocyte counts, and nausea. No maximum phase 2 dose has been reached yet.

“The initial results are promising, especially considering the challenging and fragile nature of this patient population with extensive-stage disease and poor prognosis,” Benny Li, PhD, chief operating officer of Newsoara, said in the news release.“What stands out is the anti-tumor responses in these [patients], some who have been heavily pre-treated and have [progressed on] prior platinum-based therapy, which offers significant potential for olvi-vec to provide meaningful clinical benefits in [SCLC], even in a patient population with complex and late-stage disease. Ongoing evaluation of the phase 1b results is consequentially informing the design elements of the phase 2 portion of the clinical trial."

Reference

Genelux and Newsoara announce positive preliminary phase 1b/2 data of olvi-vec in advanced small-cell lung cancer. News release. Genelux. March 25, 2025. Accessed March 26, 2025. https://tinyurl.com/unzmc5yh