Three partial responses and no complete responses were observed among 22 evaluable patients who were treated with Catrix for more than 3 months.
No complete responses or partial responses were observed among 50 evaluable patients who were treated with Cartilade for at least 6 weeks.
Statistical Methods This study was planned to recruit 50 evaluable patients, allowing us to estimate objective tumor response to within +/- 15% with 95% confidence.
The trial was conducted with one interim analysis after nine evaluable patients.
Among 175 evaluable patients, only one patient met the criteria for response.
All evaluable patients were shown to have maintained the pre-specified threshold for asparaginase activity at 48 or 72 hours after dosing.
Of 62 evaluable patients, 38 patients developed complete cytogenetic remission.
The characteristics of the evaluable patients are listed in Table 1.
The response rate ranges from 13% to 19% in evaluable patients.
Among the evaluable patients, one individual who had ovarian cancer had a complete response that lasted more than 2 months.