Erytech rapporteert positieve fase-2b-resultaten voor eryaspase #DOCTORSONLY
Array#DOCTORSONLY Erytech Pharma, het biofarmaceutische bedrijf dat behandelingen van zeldzame kankervormen ontwikkelt op basis van zijn het gepatenteerde platform ERYCAPS, dat medicijnen inkapselt in rode bloedcellen, heeft vandaag resultaten van het fase-2b-onderzoek aangekondigd, waarin eryaspase (GRASPA(R)) in combinatie met chemotherapie werd onderzocht als tweedelijnstherapie
Erytech rapporteert positieve fase-2b-resultaten voor eryaspase als medicijn tegen uitgezaaide alvleesklierkanker
ERYTECH Pharma, het biofarmaceutische bedrijf dat behandelingen van zeldzame kankervormen ontwikkelt op basis van zijn het gepatenteerde platform Erycaps, dat medicijnen inkapselt in rode bloedcellen, heeft vandaag resultaten van het fase-2b-onderzoek aangekondigd, waarin eryaspase (Graspar(R)) in combinatie met chemotherapie werd onderzocht als tweedelijnstherapie tegen uitgezaaide alvleesklierkanker. De multicenter, gerandomiseerde onderzoek bereikte de vooraf geformuleerde co-primaire eindpunten. Het onderzoek wees, vergeleken met een behandeling van louter chemotherapie, op een significante verbetering in progressievrije overleving en algehele overleving bij patienten die zijn behandeld met een combinatie van eryaspase en chemotherapie.
ERYTECH Reports Positive Phase 2b Data for eryaspase for the Treatment of Metastatic Pancreatic Cancer
LYON, France-(BUSINESS WIRE)- Regulatory News:
ERYTECH Pharma , a French clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, today announced positive topline results from its Phase 2b clinical study evaluating its product candidate, eryaspase (GRASPA(R)), in combination with chemotherapy for the treatment of second-line metastatic pancreatic cancer. The multicenter, randomized Phase 2b study met its prespecified co-primary endpoints, and showed significant improvement in both progression-free survival (PFS) and overall survival (OS) in patients treated with eryaspase combined with chemotherapy compared to chemotherapy alone.
The Phase 2b study evaluated eryaspase, L-asparaginase encapsulated in red blood cells, as a second-line treatment in combination with chemotherapy in patients with metastatic pancreatic cancer. In this 140-patient study, conducted in France, eryaspase was added to the standard of care (gemcitabine or FOLFOX) and compared to the standard of care alone in a 2-to-1 randomization.
Asparagine synthetase (ASNS) expression status in several tumor types, such as leukemia, lymphoma and pancreatic cancer, is believed to play an important role in determining sensitivity to asparaginase treatment. The primary objective of the study was to evaluate the effect of eryaspase on PFS or OS in patients with low ASNS, about 70% of the study population, with a prespecified Hazard Ratio (HR) below 0.85 for either PFS or OS. This endpoint was met showing a HR of 0.73 for PFS and 0.62 for OS.
The effect of eryaspase was furthermore demonstrated regardless of ASNS expression. In the entire patient population, the study achieved a HR of 0.57 for OS (95% CI; 0.38, 0.85) (p=0.034) with a median OS of 26.1 weeks (95% CI; 21.0, 28.9) for the eryaspase arm versus 19.0 weeks (95% CI; 12.3, 21.7) for the standard of care arm. Similar results were observed for PFS. ASNS expression does not appear to be predictive, but seems to be a prognostic factor. The role of ASNS will be further explored in future clinical studies.
The treatment was generally well tolerated.
Complete data will be presented at an upcoming medical conference, and will be submitted for publication.
Prof Pascal Hammel, MD, PhD, gastroenterologist-oncologist at Beaujon Hospital in Paris and principal investigator of the study, commented, “These results generated by eryaspase in combination with the standard of care are highly encouraging and compare favorably to gemcitabine or FOLFOX treatment administered alone. The results of this study support eryaspase as a potential treatment option for patients with metastatic pancreatic cancer in the second-line setting.”
“Pancreatic adenocarcinoma is a dismal disease with poor survival outcome,” commented Iman El-Hariry, MD, PhD, Chief Medical Officer of ERYTECH . “We believe this is the first Phase 2b study of an asparaginase product in pancreatic adenocarcinoma, yet it demonstrated a significant 43% reduction in risk of death in a very difficult-to-treat disease with few treatment options. The study had well balanced demographic and baseline patient characteristics. The improvement in OS and PFS was consistent across subgroups. The adverse events observed in this study were consistent with the known safety profile of eryaspase. We would like to thank all of our participating clinical sites for their hard work and commitment to the study.”
Gil Beyen, Chairman and CEO of ERYTECH, added, “We have been studying the metabolic pathways for the past decade with the aim to develop effective treatments for patients with metabolically-driven tumors. We are very excited by these new positive data. They provide further important clinical proof of concept supporting the development of eryaspase as a potential treatment in one of the most aggressive tumor types. We will now explore the path forward with clinicians and regulators to bring eryaspase to patients with metastatic pancreatic cancer as soon as possible. The results of this study not only reinforce the role of eryaspase in the treatment of this disease, they also provide further rationale for its evaluation in other tumor types.”
ERYTECH will hold a conference call and webcast on Tuesday, March 28 ^th at 2:30 pm CET / 8:30 am EDT, to discuss the results of its Phase 2b clinical study.
