Date: 01-May-2020

US FDA Grants Fast Track Status To Erytech’s Eryaspase To Treat Metastatic Pancreatic Cancer

Erytech Pharma, a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, announced that the US Food and Drug Administration (FDA) has granted eryaspase Fast Track Designation for the development of a second-line treatment of patients with metastatic pancreatic cancer.

“This is yet another significant milestone and meaningful validation of our technology as we continue our TRYbeCA-1 phase 3 trial evaluating eryaspase in second-line metastatic pancreatic cancer,” said Gil Beyen, CEO of Erytech. “We believe that the FDA’s Fast Track designation for eryapase underscores its potential to address this high unmet medical need.”

Erytech’s lead product candidate, eryaspase, is being evaluated in a phase 3 trial (TRYbeCA-1) in second-line metastatic pancreatic cancer in 11 countries in Europe and the United States. More than 75% of the approximately 500 patients to be enrolled in the trial have been randomized. An interim superiority analysis, to be conducted by an independent data monitoring committee (IDMC) when two-thirds of the events have occurred, is currently expected to take place around year-end 2020 and the final analysis in the second half of 2021.

In a previous phase 2b trial, eryaspase demonstrated significant improvement in both overall survival (OS) and progression-free survival (PFS) with a Hazard Ratio (HR) of 0.60 and 0.59 respectively. Overall, eryaspase was well tolerated and showed a safety profile comparable to that of standard chemotherapy.

Fast Track is a program designed to facilitate the expedited development and review of a new drug, alone or in combination with other drugs, to treat serious or life-threatening conditions for which there is a demonstration of the potential to address an unmet medical need. The purpose is to advance new drugs earlier for patients who need them.

Pancreatic cancer is a disease in which malignant (cancer) cells are found in the tissues of the pancreas. Every year, there are approximately 150,000 new cases of pancreatic cancer diagnosed in Europe and the United States. Advanced pancreatic cancer is a particularly aggressive cancer, with a five-year survival rate of less than 10%. It is currently the fourth leading cause of cancer death in Europe and the United States and is projected to rise to the second leading cause by 2030. Limited therapeutic options are currently available for this indication, thereby reinforcing the need to develop new therapeutic strategies and rational drug combinations with the aim of improving overall patient outcomes and quality of life.

TRYbeCA-1 is a randomized, controlled phase 3 clinical trial evaluating eryaspase in second-line metastatic pancreatic cancer. The trial is planned to enroll approximately 500 patients at approximately 100 clinical sites in Europe and the United States. 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 TRYbeCA-1 is overall survival. An interim superiority analysis will be conducted when approximately two-thirds of the events will have occurred.

Fast Track is a program designed to facilitate the expedited development and review of a new drug alone or in combination with other drugs to treat serious or life-threatening conditions for which there is a demonstration of the potential to address an unmet medical need. The purpose is to advance new drugs earlier for patients who need them. Fast Track addresses a broad range of serious conditions.