Olvi-Vec Shows 71% Disease Control Rate in Platinum-Resistant ES-SCLC
Early trial results show combining the oncolytic virus olvi-vec with chemotherapy led to disease control and tolerable safety in extensive-stage small cell lung cancer.
Human Lung model illness, Lung cancer and lung disease, Generative Ai: © IDoPixBox - stock.adobe.com
Preliminary results from the phase 1b/2 Olvi-Vec-SCLC-202 trial show that adding olvimulogene nanivacirepvec (olvi-vec; GL-ONC1), a modified oncolytic vaccinia virus, to platinum-based chemotherapy and etoposide may provide disease control in patients with platinum-relapsed or -refractory extensive-stage small cell lung cancer (ES-SCLC).1
The trial, which is being conducted in China, showed a 71% disease control rate (5 of 7 patients) in initial dose-escalation cohorts. The therapy yielded 2 partial responses, with all responding patients showing reduction in all target lesions. This included 1 patient achieving approximately 79% tumor regression, and they remained on treatment at the data cutoff.
Additionally, 3 patients experiencing stable disease (SD) were treated in the lower-dose cohorts. These patients had tumor reductions ranging from 24% to 29.2%.
“We are encouraged by the phase 1b trial data which suggest preliminary antitumor activity. Consistent reductions in all individual target lesions in participants experiencing disease control, combined with encouraging antitumor activity of the first evaluable participant 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 a press release.
Regarding safety, treatment with olvi-vec was generally well tolerated and had a favorable safety profile. The observed treatment-related adverse events were mostly mild to moderate, and included fever, anemia, reduced lymphocyte counts, and nausea. Further, there has been no maximum tolerated dose reached to date.
Enrollment in the dose-escalation cohorts of the study is ongoing. The trial continues to evaluate olvi-vec’s safety, as well as the recommended intravenous dose for use in the phase 2 trial.
“These results are consistent with our previous phase 2 [trial (NCT02759588)] 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,” added Zindrick.
"The initial results are promising, especially considering the challenging and fragile nature of this patient population with [ES-SCLC] and poor prognosis. What stands out is the antitumor responses in these participants, some who have been heavily pretreated 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,” Benny Li, PhD, chief executive officer of Newsoara, the drug’s Chinese co-developer, added in a press release. “Ongoing evaluation of the phase 1b results is consequentially informing the design elements of the phase 2 portion of the clinical trial."
About Olvi-Vec
Olvi-Vec is a genetically modified, proprietary, non-pathogenic, vaccinia virus with a large engineering capacity. The agent triggers immune activation and memory for long-term immunotherapy to fight against cancer.1 Preclinical studies have demonstrated its ability to infect and directly kill a wide range of tumor cell types in vitro and in vivo, supporting its clinical development across multiple malignancies.
The open-label, multicenter, phase 1b/2 Olvi-Vec-SCLC-202 study is being conducted at Shanghai Chest Hospital/Zhejiang Provincial People’s Hospital. The study is investigating olvi-vec combined with platinum-etoposide in platinum-resistant ES-SCLC.
Once enrolled in the study, patients are receiving a single cycle of olvi-vec administered over three consecutive days, followed by platinum-based chemotherapy plus etoposide after a 21-day interval. Treatment will continue until disease progression or unacceptable toxicity.
The trial's phase 1b portion focuses on dose-escalation to establish the recommended phase 2 dose (RP2D), with potential for subsequent combination with immune checkpoint inhibitors in the expansion phase if safety data permit. The phase 2 portion will further assess the safety and efficacy profile at the determined RP2D.
Notably, all 7 patients treated to date had confirmed disease progression at enrollment, including 1 heavily pretreated patient who had received 3 prior lines of therapy.
In addition to the Olvi-Vec-SCLC-202 trial, the agent is currently being evaluated in 2 clinical trials in the US. The first, OnPrime/GOG-3076 (NCT05281471), is a multi-center, randomized, open-label, phase 3 registrational trial assessing olvi-vec’s safety and efficacy when given in combination platinum-doublet plus bevacizumab (Avastin) vs physician's choice of chemotherapy and bevacizumab in patients with platinum-resistant/refractory ovarian cancer.2 Prior data from this study led to olvi-vec being granted fast track designation from the FDA in November 2023 for the treatment of patients with platinum-refractory/-resistant ovarian cancer.
The second study is VIRO-25 (NCT06463665), a multicenter, randomized, open-label, phase 2 trial evaluating the safety and efficacy of olvi-vec given with platinum-doublet and physician's choice of immune checkpoint inhibitor vs docetaxel for the treatment of patients with non–small cell lung cancer. The first patient was enrolled in this study in October 2024, and an interim readout is expected mid-2025.3
References
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/2kk6ex7t
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 March 25, 2025. Accessed March 26, 2025. https://clinicaltrials.gov/study/NCT05281471
Genelux Corporation announces first patient dosed in phase 2 trial evaluating systemic therapy with olvi-vec in non-small cell lung cancer. News release. Genelux Corporation. October 22, 2024. Accessed March 26, 2025. https://tinyurl.com/52mvvjzu
