Glen Gejerman, MD, highlights phase 3 data on CAN-2409 in localized prostate cancer

Phase 3 data from the PrTK03 trial (NCT01436968) were recently presented at the American Society for Radiation Oncology 67th Annual Meeting in San Francisco, California, highlighting the efficacy of adding CAN-2409 plus valacyclovir (prodrug) to standard-of-care external beam radiotherapy (EBRT). Overall, data showed that CAN-2409 significantly improved disease-free survival (DFS) compared with placebo plus valacyclovir in patients with newly diagnosed localized intermediate- to high-risk prostate cancer.¹

In a recent interview with Urology Times®, presenting author Glen Gejerman, MD, detailed the background and key findings from the study. Gejerman is the codirector of urologic oncology at Hackensack Meridian Health in New Jersey.

In total, the study enrolled 745 patients who were randomly assigned 2:1 to receive 3 injections of either CAN-2409 plus prodrug (n = 496) or placebo plus prodrug (n = 249) in addition to EBRT with or without short-course androgen deprivation therapy (ADT). The primary end point for the trial was DFS.

At a median follow-up of 50.3 months, data showed that CAN-2409 led to a 30% improvement in DFS (HR, 0.70; 95% CI, 0.52-0.94; P = .0155) and a 38% improvement in prostate cancer-specific DFS compared with SOC (HR, 0.62; 95% CI, 0.44-0.87; P = .0046). CAN-2409 was shown to improve DFS across all subgroups, including based on risk group and whether short-term ADT was used.

According to Gejerman, “This may be a major innovation for patients in that intermediate risk group.”

REFERENCE

1. Gejerman G, Manzanera A, Wheeler T, et al. Phase 3, randomized, placebo controlled clinical trial of CAN-2409+prodrug in combination with standard of care external beam radiation (EBRT) for newly diagnosed localized prostate cancer. Presented at: American Society of Radiation Oncology 67th Annual Meeting. September 27-October 1, 2025. San Francisco, CA. Abstract 114