Trial underway for novel agent plus immunotherapy for HPV-related head and neck cancer
Source: www.curetoday.com Author: Brielle Benyon Results from a phase 2 clinical trial demonstrated promise for the combination of the novel agent PDS0101 plus Keytruda (pembrolizumab) in treating human papillomavirus (HPV)-associated head and neck cancer. As such, the trial will now progress to full enrollment of 54 patients who have not been previously treated with a checkpoint inhibitor. The trial, VERSATILE-002, involves two groups of HPV16-positive patients with head and neck cancer that is either metastatic or has returned after treatment. One group consists of patients who have no prior treatment with checkpoint inhibition immunotherapy, while the other group is made up of 21 patients whose disease failed checkpoint inhibition — assessment for this group is still ongoing. In the checkpoint inhibitor-naïve group, four or more of the 17 patients achieved an objective response, which was classified by a 30% or more reduction in tumor size. “The achievement of this important milestone in the VERSATILE-002 phase 2 clinical trial strengthens the evidence of our novel Versamune platform’s potential ability to induce high levels of tumor-specific CD8+ killer T-cells that attack the cancer to achieve tumor regression,” commented Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech, the developer of PFS101, in a statement. “The initial data solidifies our belief that PDS0101’s demonstrated preclinical efficacy when combined with Keytruda has the potential to significantly improve clinical outcomes for patients with advanced HPV16-positive head and neck cancers.” PDS0101 works by inducing large quantities of CD4+ helper and CD8+ killer T cells, a [...]