Candel Therapeutics Announces Final Overall Survival Data from Phase 2 Clinical Trial of CAN-2409 and Valacyclovir in Patients with Borderline Resectable PDAC
NEEDHAM, Mass., Feb. 25, 2025 – Candel Therapeutics, Inc. (Candel or the Company), a clinical stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, recently announced the final overall survival (OS) data from the completed randomized controlled phase 2 clinical trial of CAN-2409, a novel immune-oncology agent, in combination with valacyclovir (prodrug), standard of care (SoC) chemoradiation, and resection, in patients with borderline resectable pancreatic ductal adenocarcinoma (PDAC).
About PDAC
PDAC is a deadly and aggressive form of pancreatic cancer. The five-year survival rate for patients diagnosed with PDAC is less than 10%. The current standard of care for patients with borderline resectable PDAC includes neoadjuvant chemoradiation followed by surgical resection. However, many patients do not respond well to this treatment, and the disease often recurs.
Trial Design and Results
The randomized controlled phase 2 trial enrolled 118 patients with borderline resectable PDAC. Participants were randomized to receive either CAN-2409 and valacyclovir plus SoC chemoradiation and resection (n=59) or SoC chemoradiation and resection alone (n=59). The primary endpoint of the trial was OS. The trial met its primary endpoint, demonstrating a statistically significant improvement in OS for the CAN-2409 and valacyclovir combination arm compared to the control arm (HR=0.68, 95% CI: 0.47-0.98, p=0.035).
Implications for Patients
The results of the trial represent a significant step forward in the treatment of borderline resectable PDAC. The combination of CAN-2409 and valacyclovir not only improved OS but also showed a trend towards improved progression-free survival (PFS) and disease control rate (DCR). These findings suggest that the combination therapy could provide a more effective treatment option for patients with borderline resectable PDAC than the current standard of care.
Implications for the World
The announcement of the positive results from the Candel Therapeutics trial has generated significant excitement in the oncology community. This innovative approach to treating borderline resectable PDAC could lead to improved outcomes for thousands of patients each year. Furthermore, the success of this trial could pave the way for the development of new combination therapies for other types of cancer. The potential impact of this development on the cancer treatment landscape is enormous.
Conclusion
The final overall survival data from the Candel Therapeutics phase 2 clinical trial of CAN-2409 and valacyclovir in patients with borderline resectable PDAC represents a significant step forward in the treatment of this deadly disease. The combination therapy demonstrated a statistically significant improvement in OS, suggesting a more effective treatment option for patients with borderline resectable PDAC. The implications of this development for the oncology community and the world are enormous, and it is expected that this approach will lead to improved outcomes for thousands of patients each year and pave the way for the development of new combination therapies for other types of cancer.
- Candel Therapeutics announces final overall survival data from phase 2 clinical trial of CAN-2409 and valacyclovir in patients with borderline resectable PDAC
- The trial demonstrated a statistically significant improvement in OS for the combination therapy arm compared to the control arm
- The results could lead to improved outcomes for thousands of patients each year and pave the way for the development of new combination therapies for other types of cancer
