Candel Therapeutics Presents Positive Phase 3 CAN-2409 Results in Localized Prostate Cancer at ASCO 2025

Core Insights - Candel Therapeutics announced positive results from its phase 3 clinical trial of CAN-2409 for localized prostate cancer, which will be presented at the 2025 ASCO Annual Meeting [1][2][4] Clinical Trial Results - The phase 3 trial met its primary endpoint, showing a statistically significant improvement in disease-free survival (DFS) with a p-value of 0.0155 and a 30% reduction in the risk of recurrence or death (HR 0.7) for patients receiving CAN-2409 compared to placebo [2][4] - The trial included 496 patients receiving CAN-2409 and 249 patients receiving placebo, marking the first multicenter, randomized phase 3 trial in over 20 years to meet both primary and secondary endpoints in localized prostate cancer [2][3] Clinical Significance - The improvement in DFS is considered clinically meaningful, with tissue analysis indicating a higher rate of pathological clinical response in patients treated with CAN-2409 [3] - Approximately 30% of patients with intermediate-to-high-risk localized prostate cancer experience disease recurrence after standard treatments, highlighting the unmet need for effective therapies [3][10] Safety and Tolerability - CAN-2409 was generally well tolerated, with a low incidence of treatment-related serious adverse events (1.7% for CAN-2409 plus standard care vs. 2.2% for placebo plus standard care) [10] - Common adverse events included flu-like symptoms, fever, and chills, which were mostly mild to moderate [10] Future Developments - Candel plans to submit a Biologics License Application (BLA) for CAN-2409 in the fourth quarter of 2026, aiming to provide better treatment options for patients [3][10] - The company is also evaluating CAN-2409 in other cancers, including non-small cell lung cancer and pancreatic adenocarcinoma, and has received Fast Track Designation from the FDA for its use in pancreatic cancer [10][11]