Auspicious Agent

Novel Drug Highly Active in CLL Patients

John ByrdAn interim analysis of a phase II clinical trial indicates that an experimental agent for chronic lymphocytic leukemia (CLL) is highly active and well tolerated both in previously treated patients and in those who have relapsed and are resistant to other therapy.

The agent, PCI-32765, is the first drug designed to target Bruton’s tyrosine kinase, a molecule essential for CLL-cell survival and proliferation.

Study leader John C. Byrd, MD, director of the Division of Hematology at Ohio State, presented the findings at the 2011 American Society of Clinical Oncology (ASCO) annual meeting in Chicago.

The trial involves 78 patients with previously untreated or relapsed and refractory CLL or small lymphocytic leukemia. This analysis involved the first 21 cases in the untreated-patient group and the first 27 individuals in the relapsed/refractory-patient group. One patient in each group had a complete remission, while 13 patients in the previously untreated group and 12 patients in the relapsed group had partial remissions.

“These are early findings, so patients with partial remissions could improve to complete remissions with further observation,” Byrd says.

Amy Johnson, PhD, co-led pre-clinical CLL work on PCI-32765 at Ohio State, along with Byrd. Those findings, published in the journal Blood, showed that the agent targets B lymphocytes and spares T lymphocytes. If the agent behaves the same way in humans, “It could dramatically improve outcomes for CLL patients,” Byrd says.

Published in the journal Blood.

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