Core Insights - Candel Therapeutics announced final overall survival data from a phase 2 clinical trial of CAN-2409 combined with standard of care for patients with borderline resectable pancreatic ductal adenocarcinoma (PDAC) [1][2] Group 1: Clinical Trial Results - The trial showed a significant improvement in estimated median overall survival of 31.4 months for the CAN-2409 group compared to 12.5 months for the control group [5][6] - Three out of seven patients treated with CAN-2409 were alive at 66.0, 63.6, and 35.8 months post-enrollment, with survival from diagnosis at 73.5, 68.8, and 41.3 months respectively [6][5] - The safety profile of CAN-2409 was generally favorable, with no dose-limiting toxicities reported [5][10] Group 2: Mechanism and Designation - CAN-2409 is a first-in-class multimodal immunotherapy designed for in situ vaccination against tumors, potentially improving outcomes in difficult-to-treat cancers like PDAC [3][8] - The therapy has received Fast Track Designation and Orphan Drug Designation from the FDA for the treatment of PDAC [5][7] Group 3: Future Directions - Based on the promising findings, the company plans to prepare for a larger, late-stage randomized controlled clinical trial of CAN-2409 in PDAC [7][9] - Candel is also evaluating CAN-2409 in other cancers, including non-small cell lung cancer and localized prostate cancer, where it has shown statistically significant improvement in disease-free survival [9][10]
Candel Therapeutics Announces Positive Final Survival Data from Randomized Controlled Phase 2 Clinical Trial of CAN-2409 in Non-Metastatic Pancreatic Cancer