Erytech’s Metastatic Pancreatic Cancer Treatment
A clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, Erytech pharma, has now announced positive data from its Phase 2b study evaluating eryaspase (GRASPA) in combination with chemotherapy for the treatment of metastatic 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. Pancreatic cancer is a particularly aggressive cancer, with a five-year survival rate of approximately 9%. It is currently the fourth leading cause of cancer death in the United States and is projected to rise to the second leading cause by 2030.
The Phase 2b study was an open-label, multi-center, randomized clinical study that evaluated eryaspase, L-asparaginase encapsulated in red blood cells, as a second-line treatment in combination with chemotherapy in 141 patients suffering from metastatic pancreatic cancer.
The eryaspase technology encapsulates L-asparaginase within donor-derived red blood cells. The amino acid, L-asparagine, is essential for cancer cell survival and proliferation.
Cancer cells do not have the enzymes required to produce L-asparagine themselves, so they source it from the blood. GRASPA depletes L-asparagin
e in the blood, which affects cancer growth and survival.The amino acid is a common component of chemotherapy, but it causes side effects that are too much for patients with a weak performance status. Encapsulation overcomes allergy and toxicity, providing patients with a form of the therapy that can be tolerated. It also prevents recognition of the enzyme by antibodies, so it can function for an extended period.
As reported in topline results earlier this year, the study met its co-primary endpoints of OS and PFS with Hazard Ratios (HR) below 0.85 in patients with no or low asparagine synthetase expression (ASNS 0/1), approximately 70% of the study population, and demonstrated statistically significant improvements of OS and PFS in the entire patient population. The associated sensitivity analyses and subgroup evaluations indicate the consistent treatment benefit with eryaspase across the treated populations.
Dr. Iman El-Hariry, Chief Medical Officer of ERYTECH, stated, “Despite intense research efforts, limited progress has been made toward increased overall survival and metastatic pancreatic cancer remains a high unmet medical need.We are quite impressed with this study outcome, particularly with the overall survival advantage demonstrated in the eryaspase arm. These results underscore the importance of targeting the metabolic pathways in pancreatic cancer and potentially other solid tumors.”
“We are very pleased by the results from this landmark study. The full picture emerging from these data shows a robust clinical benefit in this particularly difficult-to-treat and highly morbid form of cancer,” said Gil Beyen, Chairman and CEO of ERYTECH. “Eryaspase adds an entirely new mode of action to the fight against this terrible disease and opens avenues to other solid tumor indications. We are working with the regulatory agencies to develop a Phase 3 plan in pancreatic cancer, and we are exploring other solid tumor indications for our product candidate.”
