Candel Therapeutics Presents Phase 3 Clinical Trial of CAN-2409 in Localized Prostate Cancer at ASTRO 2025

Core Insights - CAN-2409 demonstrated improved disease-free survival in patients with intermediate-to-high-risk localized prostate cancer compared to placebo, regardless of the radiation therapy modality used [1][2][5] - The study represents the first significant advancement in localized, non-metastatic prostate cancer treatment in over 20 years [2][5] Clinical Trial Details - The phase 3 clinical trial (NCT01436968) enrolled 745 patients, randomized 2:1 to receive either CAN-2409 plus valacyclovir with standard care or standard care alone [2] - The trial achieved a 30% improvement in disease-free survival (HR 0.7, p=0.0155) and a 38% improvement in prostate cancer-specific disease-free survival (HR 0.62, p=0.0046) [2] - At two years, the pathological complete response rates were 80.4% in the treatment group compared to 63.6% in the control group (p=0.0015) [2] Efficacy and Safety - CAN-2409's efficacy was maintained across different radiation modalities, including moderate hypofractionated radiation, which is more convenient for patients [4][5] - Safety profiles were similar between treatment and control groups, with grade ≥ 3 treatment-related adverse events being comparable [6] Regulatory and Development Plans - The company plans to submit a Biologics License Application for CAN-2409 in Q4 2026 [5] - CAN-2409 has received various designations from the FDA, including Regenerative Medicine Advanced Therapy Designation and Fast Track Designation for multiple cancer types [8]