Candel Therapeutics’ Phase 3 Trial Shows 30% DFS Boost in Prostate Cancer
CADL•Candel Therapeutics’ pivotal phase 3 trial of aglatimagene besadenovec plus radiotherapy in 745 intermediate- to high-risk localized prostate cancer patients demonstrated a 30% improvement in disease-free survival (hazard ratio 0.70, p=0.016). Findings also showed an 80% pathological complete response rate and favorable safety, supporting a BLA submission in Q4 2026.
1. Pivotal Phase 3 Trial Design and Efficacy
Candel Therapeutics enrolled 745 intermediate- to high-risk localized prostate cancer patients in a randomized, double-blind, placebo-controlled Phase 3 trial of aglatimagene plus valacyclovir with standard radiotherapy. The study met its primary endpoint, showing a 30% improvement in disease-free survival (hazard ratio 0.70; p=0.016) compared to placebo.
2. Pathological Complete Responses and Safety Profile
A two-year post-radiotherapy biopsy review found an 80% pathological complete response rate in the aglatimagene arm versus 63% in the placebo group (p=0.0018). Treatment-related adverse events were predominantly grade 1-2, including chills, flu-like symptoms and fatigue, with no increase in clinically significant toxicity.
3. Regulatory Pathway and Market Outlook
These pivotal data support Candel’s planned Biologics License Application submission in Q4 2026. Positive phase 3 results and favorable safety could accelerate regulatory review and position aglatimagene for potential approval in localized prostate cancer, potentially expanding its use in solid tumor immunotherapies.
