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news.ImmunoGen has reported that AVE9633, a TAP compound, demonstrated evidence of biological activity in multiple patients with relapsed or refractory acute myeloid leukemia and was found to be generally well tolerated.
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The Phase I study was designed to assess the safety of AVE9633 when administered on days 1 and 8 of a 28-day cycle. Increasing doses of the compound were evaluated in new cohorts of patients until dose-limiting toxicity was observed, to identify these toxicities and to establish the recommended dose of the compound.
A total of seventeen patients with relapsed or refractory acute myeloid leukemia (AML) have been treated to date with doses ranging from 30 to 150 mg/m2/week (three to six patients per dose level). Dose-limiting toxicity occurred at the 150 mg/m2 dose level and consisted of elevated liver enzymes in one patient and keratitis in another patient. Evidence of biological activity was noted in seven of these seventeen patients. Three more patients will be enrolled in this trial at the 130 mg/m2 dose level. Additionally, another Phase I study is underway that evaluates AVE9633 administered on days 1, 4, and 7 in a 28-day cycle in patients with relapsed/refractory AML.
AVE9633 is in Phase I development for the treatment of AML. This TAP compound consists of ImmunoGen’s DM4 cell-killing agent and huMy9-6 CD33-binding antibody. ImmunoGen initially developed AVE9633 and licensed the compound to sanofi-aventis as part of a broader collaboration between the companies.
Mitchel Sayare, chairman and CEO of ImmunoGen, said: “In addition to the AVE9633 and SAR3419 findings presented, our collaborator Sanofi-Aventis also reported very encouraging clinical data on the naked antibody, AVE1642, which we initially developed and now is in broad development by them.”