Candel’s Prostate Cancer Therapy Shows 39% Recurrence Risk Reduction in Phase 3 Trial

Event summary

  • Candel Therapeutics reported extended follow-up data from its Phase 3 trial of aglatimagene besadenovec (CAN-2409) in localized prostate cancer, showing a 39% improvement in prostate cancer-specific disease-free survival (DFS) compared to placebo.
  • The trial, involving 745 patients, demonstrated a statistically significant reduction in recurrence risk after a median follow-up of 58 months.
  • In the intermediate-risk subgroup (85% of the study population), aglatimagene showed a 90% reduction in time to metastasis (TTM) versus placebo.
  • Candel plans to submit a Biologics License Application (BLA) to the FDA in Q4 2026.

The big picture

Candel Therapeutics’ Phase 3 trial results for aglatimagene besadenovec represent a significant step forward in the treatment of localized prostate cancer, addressing a substantial unmet medical need. The data suggest the potential to redefine the standard of care, particularly for intermediate-risk patients, who comprise the majority of the study population. The upcoming BLA submission in Q4 2026 will be a critical milestone in determining the therapy’s commercial viability.

What we're watching

Regulatory Approval
Whether the FDA will approve aglatimagene besadenovec based on the Phase 3 trial data, potentially making it the first new therapy for localized prostate cancer in over 20 years.
Market Impact
How the extended clinical benefits observed in the trial will position Candel Therapeutics in the competitive landscape of prostate cancer treatments.
Long-term Efficacy
The pace at which additional long-term data will confirm the durability of aglatimagene’s clinical benefits, particularly in reducing metastasis and the need for salvage therapy.