Candel Therapeutics announces overall survival data from Phase 2 CAN-2409 trial

Candel Therapeutics (CADL) announced final overall survival data from the completed randomized controlled phase 2 clinical trial of CAN-2409 plus valacyclovir, together with standard of carechemoradiation, followed by resection, in patients with borderline resectable PDAC. Final data of the randomized controlled clinical trial, updated with an additional nine months of follow-up, confirmed a durable improvement in survival for patients treated with CAN-2409 plus SoC therapy compared to SoC alone. Notably, long-term survivors in the CAN-2409 arm, remaining alive at 66.0, 63.6, and 35.8 months post-enrollment experienced disease recurrence but, in contrast to patients in the control arm with disease recurrence, responded to salvage chemotherapy and have experienced extended and ongoing post-progression survival at the time of the data cutoff, further highlighting the sustained benefit of CAN-2409 in this aggressive disease setting. Data highlights: Prolonged and sustained survival was observed in this randomized controlled clinical trial after experimental treatment with CAN-2409 compared to the control group in patients with borderline resectable PDAC. Estimated median overall survival after enrollment was 31.4 months in the CAN-2409 group versus only 12.5 months in the control group. Median survival post-progression was 21.2 months in patients who received CAN-2409 compared to 7.2 months in the control arm. Importantly, three out of seven patients who received CAN-2409 were still alive at the time of data cut-off with a survival of 66.0, 63.6, and 35.8 months, respectively, after enrollment; survival from the time of diagnosis for these patients was 73.5, 68.8, and 41.3 months, respectively. Of these, the first patient had stage IV metastatic disease detected during surgery, the second had residual tumor present at the resection margin, and the third had adenocarcinoma with negative resection margins. In contrast, only one out of six patients randomized to SoC chemotherapy arm remained alive at the data cut-off; histologic analysis at resection showed intraepithelial neoplasia in this patient, which is associated with improved prognosis. Previous analysis at 24 months showed survival rates of 71.4% in patients treated with CAN-2409 compared to 16.7% in the control group. Previous analysis of blood and resected tumors showed consistent and robust activation of the immune response after experimental treatment with CAN-2409. In pancreatic tissue of patients treated with CAN-2409 plus prodrug, together with SoC, dense aggregates of CD8+ granzyme B+ cytotoxic tumor infiltrating lymphocytes, dendritic cells, and B cells were observed in the tumor microenvironment. Increased levels of soluble granzymes B and H, along with pro-inflammatory cytokines, including IFN-gamma, were detected in peripheral blood following CAN-2409 treatment, but not in the control arm, supporting CAN-2409’s ability to drive a potent systemic anti-tumoral immune response. CAN-2409 continued to be associated with a favorable safety/tolerability profile. The addition of CAN-2409 regimen to SoC was generally well-tolerated, with no dose-limiting toxicities, including no cases of pancreatitis.