A French biotech firm testing a unique treatment approach for metastatic pancreatic cancer reported promising mid-stage results for its lead candidate.
Erytech Pharma evaluated eryaspase (Graspa), an enzyme called L-asparaginase encapsulated in red blood cells, in combination with chemotherapy as a second line treatment for 141 patients diagnosed with metastatic pancreatic cancer through a phase IIb study.
Investigators compared eryaspase and chemotherapy, either gemcitabine or FOLFOX, against the standard of care alone in a 2-to-1 randomization.
Results showed the drug met its co-primary endpoints of overall survival (OS) and progression-free survival (PFS) with hazard ratios below 0.85 in patients with no or low asparagine synthetase expression.
Furthermore, there was a statistically significant improvement in OS and PFS throughout the entire patient population.
Median OS reached 26.1 weeks in the patient group taking eryaspase compared to 19 weeks in the standard of care arm. The eryaspase arm produced median PFS of 8.6 weeks in the eryaspase compared 7 weeks in the standard of care group.
“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,” said Dr. Iman El-Hariry, Chief Medical Officer of Erytech, in a statement.
Eryaspase has produced positive efficacy and safety results in different studies in acute lymphoblastic leukemia, but this specific study signifies a first step in treating 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 Erytech’s Chairman and CEO Gil Beyen, in a statement. “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.”
Data from this study was presented at the European Society for Medical Oncology taking place in Madrid, Spain.
Filed Under: Drug Discovery