ONCASPAR^Ò was also studied in non-hypersensitive, relapsed ALL patients who were randomized to receive two doses of ONCASPAR^Ò at 2,500 IU/m² every 14 days or twelve doses of E. coli L-asparaginase at 10,000 IU/m² three times a week during a 28-day induction combination chemotherapy regimen (which included vincristine and prednisone). Although the enrollment in this study was too small to be conclusive, the data showed that for 20 patients there was no significant difference between the overall response rates of 60% and 50%, respectively, or the complete remission rates of 50% and 50%, respectively.

ONCASPAR^Ò was administered during maintenance therapy regimens to 33 previously hypersensitive patients. The average number of doses received during maintenance therapy was 5.8 (range of 1 to 24) and the average duration of maintenance therapy was 126 (range of 1 to 513) days for this patient population.

REFERENCES

1. Capizzi, RL and Holcenberg, JS. Asparaginase. In: Holland and Frei (eds). Cancer Med third edition, Lea and Febiger, Phila. PA, 1993.

2. Ho, DH, et al. Clinical pharmacology of polyethylene glycol-L-asparaginase. Drug MetabDispos 14 (3): 349-352, 1986.

3. Asselin, BL, et al. Comparative Pharmacokinetic Studies of Three L-asparaginase Preparations. J Clin Oncology (11): 1780-1786, 1993.

4. Data on File at ENZON.

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