Candel Therapeutics Phase 3 aglatimagene data shows 39% DFS improvement
Candel Therapeutics announced extended follow-up data from its pivotal Phase 3 trial of aglatimagene besadenovec (CAN-2409) for localized prostate cancer. The data confirmed a statistically significant 39% improvement in prostate cancer-specific disease-free survival compared to placebo, with a median follow-up of 58 months. The study also showed consistent clinical benefits across secondary and exploratory endpoints, including a 90% reduction in time to metastasis in intermediate-risk patients. The company plans to submit a Biologics License Application to the FDA in Q4 2026.
Key Highlights
- Aglatimagene showed 39% improvement in prostate cancer-specific disease-free survival (DFS) vs. placebo.
- Median follow-up for the Phase 3 study was 58 months.
- Intermediate-risk subgroup (85% of patients) showed 90% reduction in time to metastasis (TTM).
- Intermediate-risk subgroup also demonstrated 41% improvement in PCa-specific DFS.
- Company plans Biologics License Application (BLA) submission to FDA in Q4 2026.
- Favorable trends observed in ITT population for TTBF (HR 0.72), TTM (HR 0.58), and TTNT (HR 0.72).
Price Impact
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