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Merck Suspends Enrollment in Cancer Trials

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Merck has suspended enrollment in clinical trials for the investigational Aurora kinase inhibitor, MK-0457, pending analysis of all efficacy and safety data for the drug. The decision was based on preliminary safety data, in which a clinical safety finding of QTc prolongation was observed in one patient. Merck and collaborative partner Vertex Pharmaceuticals, Inc. have a broad R&D program underway to evaluate Aurora kinase inhibitors targeting cancer.

MK-0457 is being studied in a Phase II trial in patients with treatment-refractory chronic myelogenous leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL), as well as a Phase I trial in patients with advanced leukemias. Patients currently enrolled in these trials may continue to be treated with the drug, 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. Also, development of the Aurora kinase inhibitor MK-6592 has been discontinued after the compound did not meet pharmacokinetic objectives in a Phase I study.

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