Thursday, Candel Therapeutics Inc CADL released updated interim survival data from the ongoing phase 2 trial of CAN-2409 plus valacyclovir (prodrug), together with standard of care (SoC) chemoradiation, followed by resection for borderline resectable pancreatic ductal adenocarcinoma.
Survival data were updated with eight months of further follow-up since the first analysis was presented at the 2023 Society for Immunotherapy Annual Meeting.
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Data Highlights as of March 29, 2024, Data Cut-off, Include:
Prolonged and sustained survival was observed after experimental treatment with CAN-2409 in patients with borderline resectable PDAC (n=13).
The estimated median overall survival was 28.8 months in the CAN-2409 group versus only 12.5 months in the control group.
At 24 months, a survival rate of 71.4% was observed in CAN-2409 treated patients after SoC chemoradiation and before surgery, versus only 16.7% in the control group.
At 36 months, a survival rate of 47.6% was estimated in patients who received CAN-2409, together with SoC chemoradiation before surgery, versus only 16.7% in the control group.
4 out of 7 patients who received CAN-2409 were still alive at the time of data cut-off, with two patients surviving more than 50.0 months from enrollment.
Only 1 out of 6 patients, randomized to control SoC chemotherapy, remained alive at data cut-off (alive at 50.6 months).
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 and SoC, dense aggregates of CD8+ granzyme B positive cytotoxic tumor-infiltrating lymphocytes, dendritic cells, and B cells were observed.
CAN-2409 continued to be associated with a favorable safety/tolerability profile.
The addition of the CAN-2409 regimen to SoC was generally well tolerated, with no dose-limiting toxicities, including no cases of pancreatitis.
Price Action: CADL shares are up 31.70% at $2.21 on the last check Thursday.
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