Candel Therapeutics Inc reported peer-reviewed publication of pivotal phase 3 prostate cancer trial results in The Lancet Oncology, and the company’s shares declined 2.4% in premarket trading on Tuesday after the paper was released.
The published study evaluated aglatimagene besadenovec administered in combination with standard-of-care radiotherapy in patients with intermediate- to high-risk localized prostate cancer. The randomized trial enrolled 745 patients and met its primary endpoint.
Efficacy outcomes reported
The trial showed a 30% improvement in disease-free survival for patients who received aglatimagene compared with those given placebo, corresponding to a hazard ratio of 0.70 and a p-value of 0.016. Prostate cancer-specific disease-free survival improved by 38% in the aglatimagene arm, with a hazard ratio of 0.62 and a p-value of 0.0046.
In a post-hoc analysis of biopsy samples collected two years after completion of radiotherapy, negative biopsies were observed in 80% of patients treated with aglatimagene compared with 63% in the placebo group.
Safety profile
The manuscript describes a favorable safety profile for the investigational regimen. Most treatment-related adverse events were reported as grade 1-2 and self-limited. Commonly noted events included chills, flu-like symptoms, fatigue, pyrexia, pollakiuria, and nausea.
Prior disclosures and extended follow-up
Candel initially announced these phase 3 results in December 2024. The company later presented extended follow-up data at the American Urological Association 2026 Annual Meeting. That additional follow-up, covering an extra 20 months, showed a 39% improvement in prostate cancer-specific disease-free survival. Median follow-up reached 58 months as of March 15, 2026, according to the company’s disclosures.
Regulatory pathway
The published data will be used to support Candel’s planned Biologics License Application submission for aglatimagene, which the company intends to file in the fourth quarter of 2026.
Market reaction
Despite the peer-reviewed publication and statistically significant trial results, Candel’s stock moved lower in premarket trading on the day The Lancet Oncology article appeared. The equity reaction underscores market sensitivity to new clinical data and the timing of subsequent regulatory steps.
Note on scope: This report presents the results and related company disclosures as published. It does not project regulatory outcomes beyond the company’s stated plan to submit a Biologics License Application in the fourth quarter of 2026.