Erytech Pharma (Euronext Paris: ERYP - Nasdaq: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating drug substances inside red blood cells, today announced that the first three patients have been enrolled in its pivotal Phase 3 clinical trial, named ‘TRYbeCA1’, evaluating its lead product candidate eryaspase for the treatment of second line metastatic pancreatic cancer.
The TRYbeCa1 (NCT03665441) trial will enroll approximately 500 patients with second line metastatic pancreatic cancer in 120-130 clinical sites in Europe and the US. Patients who meet the eligibility criteria are randomized 1-to-1 to receive eryaspase in combination with standard chemotherapy (gemcitabine/abraxane or irinotecan -based regimen) or chemotherapy alone until disease progression. The primary endpoint is overall survival. An interim analysis is foreseen when approximately two-thirds of events have occurred.
The launch of the TRYbeCA1 Phase 3 trial follows the positive Phase 2b results in the same patient population, that were reported in September 2017. This open-label, multi-center, 2-to-1 randomized study in 141 patients demonstrated significant improvement in both overall survival and progression-free survival. Overall, eryaspase was well tolerated and showed a safety profile comparable to that of standard chemotherapy.
“The results from our landmark Phase 2b study are highly promising and underscore the importance of targeting tumor metabolism pathways in pancreatic cancer. We are hopeful to provide a novel treatment modality for this highly unmet medical need. We are very pleased that eryaspase has now moved into Phase 3 and patient enrollment has started as planned. Our first three enrolled patients mark the initiation of the trial in Europe. Early next year, we expect sites in the United States will begin enrolling as well,” commented Iman El-Hariry, Chief Medical Officer.
About Pancreatic Cancer
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.