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 co-director 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 external beam radiotherapy (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 to 0.94; P = .0155) and a 38% improvement in prostate cancer-specific DFS compared with SOC (HR, 0.62; 95% CI, 0.44 to 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, California. Abstract 114