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Positive preliminary data from the phase 1b/2 trial evaluating Olvi-Vec in small cell lung cancer have been announced.
Olvi-Vec shows positive disease control and manageable safety in advanced small cell lung cancer, with partial responses and tumor reductions in a phase 1b/2 trial.
Positive preliminary data regarding safety and anti-tumor activity have been announced from a phase 1b/2 clinical trial evaluating Olvi-Vec (olvimulogene nanivacirepvec) among patients with advanced small cell lung cancer (SCLC).
Findings from the dose escalation phase 1b portion of the ongoing phase 1b/2 OLVI-VEC-SCLC-202 clinical trial of Olvi-Vec immunochemotherapy in patients with platinum-relapsed or platinum-refractory extensive small cell lung cancer were announced in a news release from late clinical-stage immuno-oncology company Genelux Corporation and pre-commercial stage biopharmaceutical company Newsoara BioPharma Co., Ltd.
The systemic administration of Olvi-Vec among the initial dose escalation cohorts resulted in a 71% disease control rate (five of seven patients), with two patients experiencing a partial response. All patients with disease control experienced a reduction in all target lesions, including one patient who had a tumor reduction of approximately 79%, according to the news release. Furthermore, the news release noted that three participants, including one who had received three prior lines of treatment, achieved stable disease in lower dose cohorts, with tumor size reductions of 24% to 29.2%.
Regarding safety, the news release stated that intravenous Olvi-Vec had a manageable safety and tolerability profile, with mostly mild to moderate treatment-related side effects including fever, anemia, reduced lymphocyte counts and nausea, with a maximum tolerated dose not having been reached yet.
Disease control rate: patients who achieve a complete response, partial response or stable disease.
Partial response: a decrease in tumor size or the extent of cancer in the body in response to treatment.
Stable disease: cancer that is not increasing or decreasing in extent or severity.
“We are encouraged by the Phase 1b trial data which suggests preliminary anti-tumor activity. Consistent reductions in all individual target lesions in participants experiencing disease control, combined with encouraging anti-tumor 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 extensive small cell lung cancer,” said Thomas Zindrick, president, CEO, and chairman of Genelux, 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.”
Olvi-Vec, as the companies explained in the news release, is a modified oncolytic vaccinia virus that is being developed for the treatment of multiple cancer types based on preclinical findings suggesting that Olvi-Vec has the potential to infect and directly kill a wide range of tumor cell types and produce an anti-tumor response.
Olvi-Vec, according to the National Cancer Institute, is also currently being evaluated in clinical trials for ovarian cancer and non-small cell lung cancer.
The OLVI-VEC-SCLC-202 trial is currently enrolling patients in China at Shanghai Chest Hospital, which is the lead clinical site, and Zhejiang Provincial People's Hospital. In the trial, patients receive a single cycle of Olvi-Vec for three consecutive days and, 21 days after the last dose, receive platinum chemotherapy plus etoposide until experiencing disease progression or intolerable toxicity.
"The initial results are promising, especially considering the challenging and fragile nature of this patient population with extensive-stage disease and poor prognosis. What stands out is the anti-tumor responses in these participants, some who have been heavily pre-treated and have failed prior platinum-based therapy, which offers significant potential for Olvi-Vec to provide meaningful clinical benefits in small cell lung cancer, even in a patient population with complex and late-stage disease,” said Dr. Benny Li, CEO of Newsoara, in the news release. “Ongoing evaluation of the phase 1b results is consequentially informing the design elements of the phase 2 portion of the clinical trial."
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