Session: 614. Acute Lymphoblastic Leukemia: Therapy, excluding Transplantation: Targeted Therapies
Hematology Disease Topics & Pathways:
Non-Biological, Therapies, chemotherapy, Clinically relevant
Methods: NOR-GRASPALL 2016 is a phase 2 multinational multicentre trial conducted in the Nordic/Baltic countries. It is a single-arm study for non-high-risk patients with ALL and hypersensitivity to PEG-asp. Eryaspase (150 U/kg) is scheduled to complete the intended course of asparaginase (1-7 doses). AEA-measurements are used as biomarkers for treatment efficacy.
Results: Since August 2017, 36 children and two adults were included in the study. Median age was 6.0 years (IQR: 3.3;8.7). 37 patients (97.4%) had clinical allergy to PEG-asp of whom 59.5% (n=22) had a severe allergic reaction. One patient (3.3%) was included due to silent inactivation. AEA-measurements were available in all patients but one (n=37), and in none of these patients AEA was detectable following PEG-asp treatment. In total, 171 doses of eryaspase were administered. A total of 34 of the 36 patients (94.7%) had AEA >100 U/L and 27 patients (71.1%) had AEA-levels >400 U/L 14 days after first eryaspase administration (expected nadir). The median AEA-level was 798 U/L [IQR: 387;864]. In total 90.7% of all samples collected 14 days after eryaspase administration had AEA >100 U/L and 69.3% had AEA >400 U/L. The median AEA-level was 621U/L [IQR: 331;962]. Adverse events with relation to eryaspase were reported in 8 of 36 patients (22%). Six patients experienced a possible allergic reaction to eryaspase; one patient had a severe allergic reaction, three patients developed a rash and two patients had “drug fever”, deemed related to eryaspase. Three of these six patients (50%) had low AEA-levels after developing allergic symptoms, the remaining patients (50%) had AEA-levels comparable with all other patients in the study. Four patients experienced adverse events related to eryaspase; two patients with mild hyperlipidaemia and two with hepatoxicity. No other severe adverse events with relation to eryaspase have been reported. Final study results will be provided at the meeting.
Conclusion: Eryaspase consistently demonstrated prolonged AEA in patients who developed hypersensitivity reactions to PEG-asp. Treatment with eryaspase was well tolerated. We conclude that eryaspase is a promising alternative to PEG-asp in case of hypersensitivity.
Disclosures: Schmiegelow: Jazz Pharmaceuticals: Other: Speaker and/or Advisory Board Honoraria ; Amgen: Other: Speaker fee; Medscape: Other: Speaker fee; Servier: Other: Educational grant. Speaker and/or Advisory Board Honoraria . Albertsen: Erytech Pharma: Other: Sponsor of the investigator initiated study: NOR-GRASPALL 2016. No financial benefits..
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