
Paul Peter Tak: Positive final survival data from CAN-2409 in borderline resectable pancreatic cancer
Paul Peter Tak, President, CEO and Board Director of Candel Therapeutics, shared a post on LinkedIn:
“Breaking news:
Candel Therapeutics announces positive final survival data from randomized controlled phase 2 clinical trial of CAN-2409 in borderline resectable pancreatic cancer.
Positive final survival data after additional follow-up showed notable improvement in estimated median overall survival of 31.4 months after experimental treatment with CAN-2409 versus only 12.5 months in the control group in patients with borderline resectable pancreatic ductal adenocarcinoma.
The separation between the two treatment arms is even greater than in April 2024.
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 standard of care chemotherapy arm remained alive at the data cut-off (61.2 months from enrollment and 65.5 months from diagnosis); histologic analysis at resection showed intraepithelial neoplasia (without evidence of residual invasive adenocarcinoma) in this patient, which is associated with improved prognosis.
Thus, improved survival was observed in the CAN-2409 arm compared to the control arm despite a more unfavorable prognosis at surgery in the CAN-2409 arm.
CAN-2409 previously received Fast Track Designation and Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of PDAC.
Based on these promising findings, the Company has decided to prepare for a larger, late-stage randomized controlled clinical trial of CAN-2409 in borderline resectable pancreatic cancer.
Recently, the Company announced positive, statistically significant topline data for CAN-2409 based on a large, randomized, placebo-controlled phase 3 clinical trial in localized prostate cancer.”
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