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Candel Therapeutics Announces CAN-2409 Achieved Primary Endpoint in Phase 3 Prostate Cancer Trial, Showing Significantly Improved Disease-Free Survival
Positive topline data for CAN-2409 viral immunotherapy achieved primary endpoint by demonstrating statistically significant and clinically meaningful benefit
About this update from Candel Therapeutics, Inc.
[{"type":"text","content":"Positive topline data for CAN-2409 viral immunotherapy achieved primary endpoint by demonstrating statistically significant and clinically meaningful benefit when combined with radiation therapy for intermediate-to-high risk, localized prostate cancerThe safety profile of CAN-2409 was generally consistent with previous studies, with no new safety signals identifiedThe phase 3 clinical trial was conducted under a Special Protocol Assessment (SPA) with the FDA NEEDHAM, Mass., Dec. 11, 2024 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, today announced results from a multicenter phase 3 clinical trial evaluating CAN-2409 viral immunotherapy in localized prostate cancer patients. In the United States alone, over 100,000 men are diagnosed with localized prostate cancer every year, and over 50,000 men currently receive radiotherapy. Prostate cancer continues to be the second leading cause of cancer death among men in the United States and there has not been any new treatment or significant change in the standard of care of localized, non-metastatic prostate cancer for over 20 years. The localized prostate cancer addressable market for CAN-2409 is potentially worth over $10 billion in the U.S. alone. The phase 3 clinical trial of CAN-2409 in intermediate-to-high-risk, localized prostate cancer met its primary endpoint, by demonstrating statistically significant improvement in disease-free survival in patients who received CAN-2409 plus prodrug (valacyclovir) combined with standard of care compared to standard of care alone. The 2:1 randomized, double-blind, placebo-controlled, multicenter clinical trial enrolled 745 patients (intent to treat population, ITT) to evaluate the effectiveness and safety of CAN-2409 plus prodrug (valacyclovir) viral immunotherapy in combination with standard of care external beam radiation therapy to improve disease-free survival (DFS) in patients with intermediate-to-high risk, localized prostate cancer. Patients were randomized and stratified for the use of short-term ( CAN-2409 is an investigational, off-the-shelf, replication-defective adenovirus that delivers the herpes simplex virus thymidine kinase (HSV-tk) gene to tumor cells. CAN...