Cancer Vaccine VB10.16 Plus Atezolizumab Yields Promising Responses in HPV16+ Advanced Cervical Cancer

A combination of VB10.16, a cancer vaccine, plus PD-L1 inhibitor atezolizumab (Tecentriq) resulted in promising responses among patients with human papillomavirus 16 (HPV16)–positive advanced cervical cancer, according to interim results from the phase 2 C-02 trial (NCT04405349).

Treatment with VB10.16 and atezolizumab yielded an overall response rate of 21% in the heavily pretreated population (n = 39), including 2 complete responses and 6 partial responses. The combination also yielded a disease control rate of 64%. Among those with PD-L1–positive disease, the ORR was 27% and the DCR was 77%. In the PD-L1–negative group, the ORR and DCR were 17% and 58%, respectively.

Updated efficacy data from the trial are expected to read out during the first half of 2023.

“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, chief executive officer at Nykode Therapeutics, said in a press release. “These interim results support Nykode’s unique approach of targeting Antigen-Presenting Cells (APCs), designed to produce a robust and long-lasting CD8 killer T cell response against cancer cells. We look forward to reporting updated efficacy data readouts from the phase 2 trial during the first half of 2023 as we continue to advance our cervical cancer program.”

The interim analysis included patients who had received a minimum of 2 prior lines of therapy with a median follow-up of 6 months. Patients received 11 intramuscular injections up to 48 weeks following the first vaccination, 5 of which were administered within the first 12 weeks followed by every 6 weeks thereafter. Atezolizumab was administered intravenously at a dose of 1200 mg every 3 weeks.

The primary end points of the study were incidence and severity of adverse effects and overall response rate. Additionally, secondary outcomes included duration of response, progression-free survival, overall survival, and immunogenicity of VB10.16 in combination with atezolizumab.

To enroll on the trial, patients needed to have persistent, current, or metastatic nonresectable squamous cell carcinoma, adeno-squamous carcinoma, or adenocarcinoma of the cervix that was ineligible for or that failed on standard treatments such as systemic chemotherapy or radiotherapy. Tumors needed to be HPV16 positive and have a new or archived biopsy for PD-L1 assessment. Those with brain metastases or leptomeningeal disease, other concomitant or prior malignant disease, or active or suspected autoimmune disease were excluded from the trial.

“The patients who were treated with VB10.16 in combination with atezolizumab in the C-02 trial were heavily pre-treated and are prone to progress quickly,” principal investigator Peter Hillemanns, MD director of the Departments of Gynecology, Obstetrics, and Breast Cancer at Hannover University Hospital, Germany, concluded. “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.”

Reference

Nykode Therapeutics announces positive interim results from its Phase 2 trial with VB10.16 in combination with immune checkpoint inhibitor atezolizumab in advanced cervical cancer. News release. Nykode Therapeutics. May 9, 2022. Accessed May 10, 2022. https://yhoo.it/37CjiZi