On June 4, 2018 ERYTECH Pharma (Euronext:ERYP) (Nasdaq:ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported that it will present pharmacodynamic characterization data from its Phase 2/3 trial of eryaspase (GRASPA) in combination with chemotherapy for the treatment of relapsed acute lymphoblastic leukemia (ALL) at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held June 1-5, 2018 in Chicago, Illinois (Press release, ERYtech Pharma, JUN 4, 2018, View Source;p=RssLanding&cat=news&id=2352888 [SID1234527117]).
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The European Phase 2/3 trial pharmacodynamic data will be presented during the poster session of the Hematologic Malignancies by Dr. Iman El-Hariry, Chief Medical Officer of ERYTECH and Dr. Philip Lorenzi,
Co-Director of the proteomics and metabolomics core facility at MD Andersen Cancer Center.
Poster Session: Pharmacodynamic Characterization of eryaspase (L-asparaginase Encapsulated in Red Blood Cells) in Combination with Chemotherapy in a Phase 2/3 Trial in Patients with Relapsed Acute Lymphoblastic Leukemia (NCT01518517).
Poster: 7049
Lead Author: Dr. Iman El Hariry
Poster Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Location: Hall A
Date: Monday, June 4
Time: 8:00 a.m. – 11:30 a.m.
This randomized Phase 2/3 study enrolled patients with relapsed ALL (n=80, age: 1-55 years), randomized to eryaspase or native ASNase in combination with chemotherapy. The study demonstrated prolonged asparaginase activity and marked reduction in allergic reactions with eryaspase, when compared with control native asparaginase. In addition, the study demonstrated an overall favorable safety profile as well as a higher complete remission (CR) rate with eryaspase.
The duration of asparagine (ASN) depletion was also evaluated in the study, and was inferior in the eryaspase arm, compared to control. These results are largely confounded by the lack of a reliable assay to measure ASN due to ex vivo depletion of ASN before the enzyme can be quenched. This can lead to over-estimation of ASN depletion with a free asparaginase enzyme, less so with an encapsulated enzyme. Importantly, ASN depletion ≤2 μM was maintained for approximately 7 days in 70% and 75% of patients, in the eryaspase and control arms, respectively. Of interest, correlation with complete remission rate suggests ASN depletion ≤2 μM may not be needed with eryaspase; rather, a level ≤7.55 μM at Day 6 may be sufficient.