Candel Therapeutics announced positive Phase 3 trial results for aglatimagene besadenovec (CAN-2409) combined with valacyclovir in patients with intermediate-to-high-risk localized prostate cancer. The trial met its primary endpoint of disease-free survival (DFS), showing a 30% risk reduction in cancer recurrence or death. These findings will be presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.
This successful trial is a significant advancement in prostate cancer treatment. It’s the first multicenter, randomized Phase 3 trial in over two decades to achieve both primary and secondary endpoints for localized prostate cancer. This offers a potential new standard of care for intermediate-to-high-risk patients seeking curative treatment, potentially reducing the need for salvage therapies and improving long-term outcomes.
The Phase 3 trial demonstrated a statistically significant improvement in DFS (p=0.0155) with a hazard ratio of 0.7. Secondary endpoints were also met, including improved DFS in patients receiving short-term androgen deprivation therapy (ADT) and those not receiving ADT. A significant increase in patients achieving a prostate-specific antigen (PSA) nadir and higher pathological complete responses in two-year post-treatment biopsies were observed. The therapy was generally well-tolerated, with primarily mild-to-moderate, self-limiting side effects.
This positive Phase 3 data strengthens Candel’s position in the prostate cancer treatment landscape. With plans to submit a Biologics License Application (BLA) in Q4 2026, CAN-2409 holds significant promise for transforming treatment options and improving outcomes for patients with intermediate-to-high-risk localized prostate cancer. This successful trial may also encourage further research into multimodal biological immunotherapies for other cancer types, expanding the potential impact of this innovative approach.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
