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Novel therapeutic agents provide hope for patients with hard-to-treat blood disorders
Date:12/9/2012

>Despite this success, no targeted treatment option exists for approximately5 to 20 percent of CML and Ph+ALL patients with the "gatekeeper" T3151 BCR-ABL mutation, which makes them resistant to available TKIs. The only treatment alternative is a hematopoietic stem cell transplant which has toxic side effects. Ponatinib, the first targeted therapy that has emerged for these hard-to-treat patients, has demonstrated excellent activity against the T3151 mutation in early clinical trials. High levels of response have also been observed in patients with other mutations or with no mutations who have experienced resistance or intolerance to two or all three available TKIs. Given these promising results, researchers conducted a pivotal Phase II trial assessing the drug.

A team of researchers from the United States and Europe enrolled 449 patients with CML and Ph+ALL who were either resistant or intolerant (R/I) to dasatinib or nilotinib or had the T3151 mutation. Patients were assigned into six cohorts based on their disease resistance or genetic profile and then treated with ponatinib. Nearly all of the patients were previously treated with two of the available TKIs (imatinib, dasatinib, and/or nilotinib) or with all three TKIs. The primary endpoint of the study was major cytogenetic response (>65% of cells are normal) within 12 months of treatment for those with chronic phase CML and major hematologic response (normal white blood cell counts) within six months after treatment for those with advanced-phase CML or Ph+ALL.

Major cytogenetic response was observed in 55 percent of all chronic-phase CML patients (50% of R/I patients and 70% with T3151 mutation), and major hematologic response was observed in 58 percent of patients with accelerated-phase CML (57% of R/I patients and 50% with T3151 mutation) and 34 percent of those with blast-phase CML/ Ph+ALL (35% of R/I patients and 33% with T3151 mutation). The similar response rates observed in patients wit
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Contact: Andrea Slesinski
aslesinski@hematology.org
614-352-5096
American Society of Hematology
Source:Eurekalert

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