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news.Bioenvision has achieved promising results in clinical trials of clofarabine in adult acute myeloid leukemia, including responses in high-risk patients.
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In a UK National Cancer Research Institute multi-center study of older patients with acute myeloid leukemia (AML) who were unsuitable for intensive chemotherapy, the overall response for clofarabine was 67%. Of the 11 patients in this trial with abnormal cytogenetics, five (45%) achieved a complete response (CR) with clofarabine. For patients with ‘normal’ cytogenetic profile, the CR was 73%.
Studies conducted at the MD Anderson Cancer Research Center (MDACC) in Texas have also provided encouraging data for clofarabine. In one of these studies, clofarabine as first line treatment in adult AML provided a CR of 52% and an overall response of 60%.
Data from a new randomized phase II study in first-line patients, supported by Bioenvision’s co-development partner, Genzyme, compared clofarabine as a single agent versus clofarabine in combination with low-dose ara-C in patients greater than or equal to 60 years. Results showed that clofarabine as a single agent achieved a CR of 45% and clofarabine in combination with low-dose ara-C achieved a CR of 60%.