The overall incidence of hypersensitivity reactions in 174 patients who received ONCASPAR^Ò in five clinical studies is shown in the table below:

The probability of previously hypersensitive or non-hypersensitive patients completing 8 doses of ONCASPAR^Ò therapy without developing a dose-limiting hypersensitivity reaction was 77% and 95%, respectively.

All of the 62 hypersensitive patients treated with ONCASPAR^Ò in five clinical studies had previous hypersensitivity reactions to one or more of the native forms of L-asparaginase. Of the 35 patients who had previous hypersensitivity reactions to E. coli L-asparaginase only, 5 (14%) had ONCASPAR^Ò dose-limiting hypersensitivity reactions. Of the 27 patients who had hypersensitivity reactions to both E. coli and Erwinia L-asparaginase, 7 (26%) had ONCASPAR^Ò dose-limiting hypersensitivity reactions. The overall incidence of dose-limiting hypersensitivity reactions in 174 patients treated with ONCASPAR^Ò was 9% (19% in 62 hypersensitive and 3% in 112 non-hypersensitive patients). Of the total of 9% dose-limiting hypersensitivity reactions, 1% were anaphylactic (CTC grade 4) and the other 8% were ≤CTC grade 3.

ONCASPAR^Ò was evaluated as part of combination therapy in four open label studies comprising 42 multiply-relapsed, previously hypersensitive acute leukemia patients [39 (93%) with ALL] at a dose of 2,000 or 2,500 IU/m² administered intramuscularly or intravenously every 14 days during induction combination chemotherapy. The reinduction response rate was 50% (36% complete remissions and 14% partial remissions), with a 95% confidence interval of 35% to 65%. This response rate is comparable to that reported in the literature for relapsed patients treated with native L-asparaginase as part of combination chemotherapy.¹

ONCASPAR^Ò was also shown to have some activity as a single agent in multiply-relapsed hypersensitive ALL patients, the majority of whom were pediatric. Treatment with ONCASPAR^Ò resulted in three responses (one complete remission and two partial remissions) in nine previously hypersensitive patients who would not have been able to receive any further L-asparaginase treatment.

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