Candel Therapeutics has reported groundbreaking results from its Phase 2 clinical trial investigating CAN-2409 for borderline resectable pancreatic cancer, demonstrating a significant survival advantage that could reshape treatment paradigms for this aggressive disease.
The randomized controlled trial showed that patients receiving CAN-2409 achieved a median overall survival of 31.4 months, compared to just 12.5 months in the control group. This striking difference represents a nearly threefold increase in survival time for treated patients.
Trial Design and Patient Outcomes
The study focused on patients with borderline resectable pancreatic cancer, characterized by tumors invading blood vessels that typically prevent immediate surgical intervention. All participants received standard-of-care treatment, consisting of chemotherapy followed by chemoradiation, with the experimental group receiving 2-3 additional administrations of CAN-2409.
Particularly noteworthy was the long-term survival data: three out of seven patients in the treatment group remained alive after extended follow-up, with two patients surviving beyond the five-year mark. This outcome is exceptional considering that typical survival rates for pancreatic cancer patients range from just 6 to 12 months.
Unprecedented Survival in Advanced Disease
Dr. Paul Peter Tak, CEO of Candel Therapeutics, emphasized the significance of these results: "Two of these three surviving patients had actually progressed to stage four metastatic disease after surgery, and one patient had residual tumor remaining. Even in these challenging scenarios, we're seeing survival beyond five years, which is virtually unheard of in the normal clinical course of this disease."
Regulatory Status and Future Development
The promising results have already attracted attention from regulatory authorities, with the FDA granting both Fast Track designation and Orphan Drug status to CAN-2409. These designations are expected to accelerate the development process.
"We believe this is a potential breakthrough in the treatment of borderline resectable pancreatic cancer," stated Dr. Tak. The company plans to confirm these findings in a larger randomized controlled trial with a similar design to the current study.
Clinical Impact and Future Applications
The implications of these results extend beyond the current patient population. If approved, Candel Therapeutics plans to investigate CAN-2409's potential in other stages of pancreatic cancer, potentially offering new hope for patients with various forms of this devastating disease.
"This reminds us every day why we are in this business," Dr. Tak reflected, "working day and night to really be on the frontier of cutting-edge science in oncology to help patients with the largest unmet need."
