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news.Merck & Co. has suspended enrollment in clinical trials of its investigational aurora kinase inhibitor for the treatment of a form of leukemia, which the company is developing in collaboration with Vertex Pharmaceuticals.
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The decision was based on preliminary safety data, in which a clinical safety finding of QTc prolongation was observed in one patient.
The drug, MK-0457, is being investigated in a Phase II trial in patients with treatment-refractory chronic myelogenous leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL) containing the T315I mutation, as well as an ongoing Phase I clinical trial in patients with advanced leukemias.
Patients currently enrolled in these trials may continue to be treated with MK-0457, with additional monitoring for QTc prolongation. A recently initiated Phase I trial of MK-0457 in combination with dasatinib in patients with CML or Ph+ALL has also been suspended.
Merck and Vertex have a broad R&D program underway to evaluate aurora kinase inhibitors as novel approaches to targeted cancer treatment. As part of Merck’s strategy to develop multiple drug candidates in different tumor types and treatment combinations, Merck plans to initiate in early 2008 a Phase I trial of VX-689 in patients with advanced and/or refractory solid tumors.