Pancreatic cancer is a particularly aggressive type of cancer, with a five-year survival rate of less than 10%. It is also one of the fastest growing cancer indications. With approximately 150,000 new cases diagnosed each year in Europe and the United States annually, pancreatic cancer represents an important unmet medical need.
In 2017, we reported positive Phase 2b clinical trial data of eryaspase in combination with chemotherapy for the second-line treatment of patients with metastatic pancreatic cancer. The open-label, randomized, multi-center clinical trial in 141 patients met its co-primary endpoints and demonstrated significant improvement in both overall survival (OS) and progression-free survival (PFS). The hazard ratio for overall survival in the entire patient population was 0.60 (nominal p-value = 0.009), meaning that treatment with eryaspase reduced the risk of death rate by 40% compared to treatment with chemotherapy alone.
This clinical trial represents the first time an asparaginase-based therapy has been reported to have a survival benefit in a solid tumor indication. This trial forms the basis for our strategy to explore the further development of eryaspase for the treatment of pancreatic cancer and other solid tumor indications.
We are currently evaluating eryaspase in the ongoing Phase 3 TRYbeCA1 trial which is expected to enroll approximately 500 second-line metastatic pancreatic cancer patients at more than 120 clinical sites in Europe and the United States. In this trial, eligible patients are randomized 1-to-1 to receive eryaspase in combination with standard chemotherapy (gemcitabine/nab-paclitaxel or an irinotecan-based regimen) or chemotherapy alone. The primary endpoint of TRYbeCA1 is overall survival. An interim efficacy analysis is planned for when approximately two-thirds of events have occurred.
Additionally, with the view of evaluating eryaspase beyond the second-line setting, an investigator sponsored Phase 1 trial with eryaspase as part of first-line treatment for metastatic pancreatic cancer is in the planning phase in the United States.