ERYTECH Reports Positive Phase 2b Data for eryaspase for the Treatment of Metastatic Pancreatic Cancer
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- Primary progression-free survival (PFS) and overall survival (OS) endpoints met in patients with low asparagine synthetase (ASNS)
- Statistically significant improvement of OS and PFS in the entire patient population
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
“Pancreatic adenocarcinoma is a dismal disease with poor survival
outcome,” commented
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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 about 150,000
new cases of pancreatic cancer diagnosed in
About ERYTECH and eryaspase (GRASPA®): www.erytech.com
Founded in
Eryaspase consists of an enzyme, L-asparaginase, encapsulated inside
donor-derived red blood cells. L-asparaginase depletes asparagine, a
naturally occurring amino acid essential for the survival and
proliferation of cancer cells, from circulating blood plasma. ERYTECH
produces eryaspase at its own GMP-approved and operational manufacturing
site in
In addition to eryaspase, ERYTECH is developing two other product candidates that focus on using encapsulated enzymes to induce tumor starvation. The company is also exploring the use of its ERYCAPS platform for developing cancer immunotherapies and enzyme replacement therapies.
ERYTECH is listed on
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Source: ERYTECH
ERYTECH
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