Mark Garzotto, MD, discusses phase 3 data on aglatimagene in localized prostate cancer

In the following interview, Mark Garzotto, MD, discusses phase 3 data on aglatimagene besadenovec (CAN-2409) presented at the 2026 American Urological Association Annual Meeting in Washington, DC. Data showed that adding aglatimagene besadenovec to standard-of-care external beam radiation therapy (EBRT) with or without short-course androgen deprivation therapy (ADT) improved prostate cancer–specific disease-free survival in patients with localized intermediate- and high-risk prostate cancer.¹

Garzotto is a professor of urology at Oregon Health & Science University in Portland, OR.

The randomized, double-blind study (NCT01436968) enrolled 745 patients, approximately 85% of whom had intermediate-risk disease. Patients received 3 intraprostatic injections of aglatimagene or placebo in combination with valacyclovir and standard-of-care radiation therapy, with up to 6 months of ADT permitted at physician discretion. Garzotto noted that the treatment arms were well balanced with respect to tumor characteristics, ADT use, and patient demographics, including representation of African American patients reflective of the US population.

At a median follow-up of 58 months, the aglatimagene arm demonstrated a 39% improvement in prostate cancer–specific disease-free survival compared with placebo (HR, 0.61; 95% CI, 0.44 to 0.85; P = .0031). Investigators also observed improved time to biochemical failure (HR, 0.72), time to metastasis (HR, 0.58), and time to new therapy (HR, 0.72) with aglatimagene, although overall survival data remain immature. Garzotto emphasized that reducing the need for additional treatments such as hormonal therapy, repeat radiation, or prostatectomy could have important quality-of-life implications for patients.

The strongest benefit was observed in the intermediate-risk subgroup, which comprised most of the study population. In these patients, aglatimagene improved prostate cancer–specific disease-free survival by 41% vs placebo (HR, 0.59; 95% CI, 0.41 to 0.84; P = .0034). Investigators also reported marked improvements in time to biochemical failure (HR, 0.48), time to metastasis (HR, 0.1), and time to new therapy (HR, 0.51) in the treatment arm.

REFERENCE

1. Garzotto M, Sylvester J, Wheeler T, et al. EXTENDED FOLLOW-UP SHOWS ACCUMULATING BENEFIT FOR PATIENTS TREATED WITH AGLATIMAGENE BESADENOVEC (CAN-2409) +PRODRUG IN COMBINATION WITH STANDARD OF CARE EXTERNAL BEAM RADIATION (EBRT) IN MEN WITH LOCALIZED PROSTATE CANCER: UPDATE FROM A RANDOMIZED PLACEBO-CONTROLLED PHASE 3 CLINICAL TRIAL. J Urol. 2026;215(5S2):e1. doi:10.1097/01.JU.0001192572.07890.f8.01