We usually focus on advanced prostate cancer, but this news is worth considering. Immunotherapy is making progress, even in a field notoriously resistant to immune therapy, such as prostate cancer.

Candel Therapeutics announced positive results from a Phase 3 clinical trial of CAN-2409, a novel viral immunotherapy, for the treatment of intermediate-to-high-risk localized prostate cancer.

The trial, conducted under a Special Protocol Assessment (SPA) with the FDA, demonstrated a statistically significant improvement in disease-free survival (DFS) in patients receiving CAN-2409 in combination with standard radiation therapy, compared to those receiving radiation therapy alone.

The primary endpoint was met, with key findings showing a 14.5% relative improvement in DFS at 54 months for the CAN-2409 treatment arm. This improvement was consistent across subgroups, including those receiving short-term androgen deprivation therapy (ADT) and those not receiving ADT. Notably, CAN-2409 also led to a significant increase in patients achieving a PSA nadir, indicating a more profound response to treatment. The safety profile was favorable, with no new safety signals identified and the most common side effects being mild to moderate flu-like symptoms.

CAN-2409 is an off-the-shelf, replication-defective adenovirus carrying the herpes simplex virus thymidine kinase (HSV-tk) gene. This gene, when combined with the prodrug valacyclovir, induces immunogenic cell death in tumor cells, exposing tumor antigens and triggering a CD8+ T cell-mediated immune response against the cancer. Preclinical and clinical evidence suggest synergistic effects when CAN-2409 is combined with radiotherapy.
Based on these results, Candel Therapeutics plans to initiate discussions with the FDA regarding the regulatory pathway for CAN-2409 approval.

Source.