Candel Therapeutics reports strong long‑term prostate cancer data ahead of FDA filing

aglatimagene besadenovec (CAN-2409) in 745 patients with localized, intermediate- to high-risk prostate cancer showed a 39% improvement in prostate cancer–specific disease-free survival versus placebo, with a hazard ratio of 0.61 and p=0.0031 after a median 58 months of follow-up; in the intermediate-risk subgroup (85% of the study population) the benefit was 41% and time to metastasis was reduced by 90% versus placebo, with very low metastasis rates; the safety profile was generally well tolerated, with mostly mild to moderate flu-like symptoms and similar rates of serious adverse events and treatment discontinuations versus placebo; the pivotal phase 3 trial was conducted under an FDA Special Protocol Assessment and Candel plans to submit a Biologics License Application for CAN-2409 in localized prostate cancer in the fourth quarter of 2026.