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Treatment with an investigational cancer vaccine plus Tecentriq was associated with positive outcomes in patients with heavily pre-treated advanced cervical cancer, according to findings from an interim analysis of a phase 2 trial.
The use of VB10.16, an investigational cancer vaccine, in combination with Tecentriq (atezolizumab) conferred promising results in patients with heavily pre-treated HPV16-positive advanced cervical cancer, according to interim study results released by Nykode Therapeutics AS, the manufacturer of the vaccine.
At a median follow-up of six months, treatment with the combination among 39 patients resulted in an overall response rate (a percentage of patients whose disease fully or partially responded to treatment) of 21%. Two patients achieved a complete response to the treatment, meaning that there was no detectable trace of cancer. Moreover, the interim results demonstrated that the disease control rate (proportion of patients who achieve a complete or partial response or have stable disease) among the patient population was 64%.
The findings also demonstrated anti-tumor activity across patient subsets. For instance, treatment with VB10.16 plus Tecentriq in patients with PD-L1—positive disease resulted in an overall response rate of 27% and a disease control rate of 77%. Patients with PD-L1—negative disease also benefitted from treatment (overall response rate of 17%; disease control rate of 58%).
“We are thrilled to report these positive interim safety and efficacy results from our phase 2 trial with VB10.16, which showed evidence of durable anti-tumor activity in a heavily pre-treated population of patients with late-stage cervical cancer,” Michael Engsig, CEO of Nykode Therapeutics, said in a press release announcing the interim findings.
Ten percent of the patients reported experiencing serious or severe (grade 3 or higher) side effects related to the use of the cancer vaccine. These results, according to the release, represent no increased toxicity compared with Tecentriq alone and are consistent with previously reported data involving the company’s vaccine technology.
The company said it plans to report further efficacy data from the phase 2 VB C-02 trial during the first half of 2023.
“The patients who were treated with VB10.16 in combination with (Tecentriq) in the C-02 trial were heavily pre-treated and are prone to progress quickly,” lead study investigator Dr. Peter Hillemanns, director of the Departments of Gynecology, Obstetrics and Breast Cancer at Hannover University Hospital in Germany, said in the release. “It is very encouraging to see that a majority of patients experienced a clinical benefit and that many patients had durable responses. The combination of VB10.16 and atezolizumab was also well tolerated by patients.”
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