ERYTECH Announces TRYbeCA-1 Phase 3 Trial in 2L Pancreatic Cancer to Continue to Final Analysis - Seite 2

About TRYbeCA-1

TRYbeCA-1 is a randomized, controlled Phase 3 clinical trial evaluating eryaspase in second-line metastatic pancreatic cancer. The trial has enrolled 512 patients, slightly above the target enrollment of 482 patients, at approximately 90 clinical sites in Europe and the United States. Eligible patients were 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 is overall survival (OS). At the target enrollment of 482 patients, the trial is powered to detect an OS benefit, measured as a hazard ratio (HR), of 0.725 (i.e. a reduction in risk of death rate by 27.5%) with 88% probability. The trial protocol includes one interim efficacy analysis, to be performed by the IDMC upon the accrual of 261 death events, and a final efficacy analysis upon reaching a total of 390 events. 

About Pancreatic Cancer

Pancreatic cancer is a disease in which malignant (cancer) cells are found in the tissues of the pancreas. It is a particularly aggressive cancer, with a five-year survival rate below 10%. Pancreatic cancer currently the fourth leading cause of cancer death in the United States and is projected to rise to the second leading cause by 2030.

Every year, approximately 200,000 new cases of pancreatic cancer are diagnosed in the United States and Europe. Approximately half of these patients are diagnosed with metastatic disease for which limited therapeutic options are currently available. Notwithstanding significant efforts, very little innovation has occurred in advanced pancreatic cancer. Chemotherapy remains the main treatment modality. Approximately 40-50% of the patients treated with chemotherapy are eligible for second-line treatment.

About ERYTECH and eryaspase

ERYTECH is a clinical-stage biopharmaceutical company developing innovative red blood cell-based therapeutics for severe forms of cancer and orphan diseases. Leveraging its proprietary ERYCAPS platform, which uses a novel technology to encapsulate drug substances inside red blood cells, ERYTECH is developing a pipeline of product candidates for patients with high unmet medical needs. ERYTECH’s primary focus is on the development of product candidates that target the altered metabolism of cancer cells by depriving them of amino acids necessary for their growth and survival.