Candel Therapeutics announced positive final overall survival data from its Phase 2 trial of CAN-2409 in patients with borderline resectable pancreatic ductal adenocarcinoma (PDAC). The experimental treatment, combined with standard chemotherapy and radiation, showed a significant increase in median overall survival to 31.4 months compared to 12.5 months for the control group. Three of the seven patients treated with CAN-2409 survived beyond 35 months, significantly exceeding typical survival rates for this aggressive cancer.
This data is particularly encouraging for PDAC patients, a population facing a historically grim prognosis. Borderline resectable PDAC is challenging to treat due to the frequent presence of undetectable micrometastases that standard therapies often miss. CAN-2409’s potential to stimulate a robust and sustained anti-tumor immune response offers hope for improved long-term survival, even in patients with residual disease after surgery. The survival data, coupled with earlier findings on immune system activation within the tumor microenvironment, suggest that CAN-2409 may be altering the disease course in a meaningful way.
The Phase 2 trial showed a median overall survival of 31.4 months in the CAN-2409 arm versus 12.5 months in the control arm. Median post-progression survival was also substantially longer in the CAN-2409 group (21.2 months) compared to the control group (7.2 months). Importantly, the therapy exhibited a favorable safety profile, with no dose-limiting toxicities observed. This positive safety profile combined with the promising survival data further strengthens the rationale for advancing CAN-2409 into a larger, late-stage clinical trial. CAN-2409 has already received Fast Track and Orphan Drug Designations from the FDA for PDAC.
The positive results from this Phase 2 trial, along with recent positive data from a Phase 3 trial in prostate cancer, suggest a broader potential for CAN-2409 across multiple solid tumors. Candel Therapeutics is planning a larger, late-stage randomized controlled trial for CAN-2409 in PDAC, which could ultimately lead to a new treatment option for this challenging cancer. This development underscores the potential of multimodal immunotherapies to improve outcomes for patients with difficult-to-treat cancers.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
