ERYTECH Pharma a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, today announced the presentation of the full data from its Phase 2b study evaluating eryaspase (GRASPA®) in combination with chemotherapy for the treatment of metastatic pancreatic cancer. The open-label, multi-center, randomized Phase 2b clinical study met its co-primary endpoints and demonstrated significant improvement in both overall survival (OS) and progression-free survival (PFS). The results will be presented during the European Society for Medical Oncology (ESMO) Annual Meeting in Madrid.
The Phase 2b study 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. In this study, conducted in France, eryaspase was added to the current standard of care (gemcitabine or FOLFOX) and compared to the standard of care alone in a 2-to-1 randomization. Approximately 90% of patients received gemcitabine. Baseline characteristics and patient demographics were similar between the two treatment groups.
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.
Principal Investigator Professor Pascal Hammel, gastroenterologist-oncologist and head of the Oncology Unit at Beaujon Hospital in Paris, commented, “The full results of this study are highly encouraging and support eryaspase as a potential treatment option for patients with metastatic pancreatic cancer in the second-line setting.”
