New therapies and gene target advance the treatment and understanding of hard-to-treat... (ther Hematological Malignancies: Emergin...)

New therapies and gene target advance the treatment and understanding of hard-to-treat leukemias

Date:12/6/2010

ther Hematological Malignancies: Emerging Safety and Clinical Response Findings [Abstract 210]

Despite the recent advances in the treatment of chronic myeloid leukemia (CML) over the past decade with both first- and second-generation BCR-ABL inhibitors, there are patients who continue to fail two or more of these therapies and/or develop a mutation called T315I, which alters the shape of the ABL enzyme, making these patients unresponsive to current therapies. Currently, there are no effective treatment options for patients who develop a T315I mutation. Pre-clinical research has demonstrated that ponatinib, an investigational pan-BCR-ABL inhibitor, may inhibit the entire spectrum of mutations that cause resistance to other BCR-ABL inhibitors.

Researchers at The University of Texas MD Anderson Cancer Center in Houston, in collaboration with colleagues from other institutions in the United States, initiated an open-label, dose escalation phase I study to assess the safety and investigate the anti-leukemic activity of ponatinib. A total of 67 patients with various refractory hematologic malignancies including CML, Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL), and acute myeloid leukemia (AML), were enrolled in the study to receive a daily oral dose of ponatinib. A large majority of patients with Ph+ CML had previously failed treatment with other BCR-ABL inhibitors (imatinib: 96 percent, dasatinib: 89 percent, nilotinib: 55 percent, more than two previous therapies: 95 percent, and more than three previous therapies: 64 percent). Additionally, 72 percent of all patients enrolled in the study had BCR-ABL mutations, with 38 percent (23 patients) having a T315I mutation and 12 percent (7 patients) having an F317L mutation.

To date, patients enrolled in the study have received up to 60 mg doses of ponatinib with 64 per
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Contact: Lindsey Love
llove@hematology.org
540-538-9326
American Society of Hematology
Source:Eurekalert

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