Nilotinib appears to help chronic myelogenous leukemia patients when standard care fails

HOUSTON -- The targeted agent nilotinib (AMN107) appears to offer striking benefits in patients with chronic myelogenous leukemia (CML) who are resistant to Gleevec, the standard therapy for this cancer, say researchers at The University of Texas M. D. Anderson Cancer Center.

Results of a 119-patient, phase I dose-escalation study, published June 15 in The New England Journal of Medicine, show that nilotinib offers a relatively favorable safety profile and obvious activity, researchers say, even though the study was not designed to measure the agent's effectiveness.

"We are very excited about this drug," says the study's lead investigator, Hagop Kantarjian, M.D., professor and chair of the Department of Leukemia. "With it, I believe we are going to make another quantum leap in the treatment of CML, allowing us to treat our patients according to their cancer's distinct molecular signature."

Nilotinib is the younger sibling of Gleevec, both of which were developed by Novartis Pharmaceuticals Corporation, which also funded the study. Preclinical studies have shown that nilotinib, which is administered in pill form, is up to 50 times more potent than Gleevec because it was designed to more efficiently bind to, and shut down, the protein enzyme responsible for the disease.

The June 15 NEJM also includes a report on a phase 1 clinical trial for dasatinib, a medication developed by Bristol-Myers Squibb for CML and acute lymphoblastic leukemia, and an editorial noting the importance of both papers' findings for CML patients and for swift, targeted drug development based on an understanding of cancer at the molecular level.

While Kantarjian notes that nilotinib seems to have fewer side effects than Gleevec, which is considered a safe drug, some patients in this trial were found to have abnormal electrical activity in their hearts, and one patient experienced two cardiac events. "We believe this issue is manageable with the right do

Contact: Scott Merville
University of Texas M. D. Anderson Cancer Center

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