Longest ever follow-up study of a targeted cancer therapy shows excellent results

ATLANTA, Ga. - The overall survival of most people with chronic myelogenous leukemia (CML) treated with imatinib (Gleevec, STI-571) is extremely high and the relapse rate is quite low, according to new data from a study out of the Oregon Health & Science University Cancer Institute. The overall survival at five years is 89 percent as compared to no more than 50 percent with prior therapies, and the risk of relapse continues to decrease the longer patients take the drug.

"This represents a complete turn around in the prognosis for patients with this disease," said Brian J. Druker, M.D., who originally collaborated with Novartis scientists to develop Gleevec into a successful treatment for CML. He is the JELD-WEN chair of leukemia research in the OHSU Cancer Institute and an investigator of the Howard Hughes Medical Institute.

Druker presented the five-year update from the IRIS (International Randomized IFN vs. ST1571) Study Group on Saturday, June 3 at the 2006 annual meeting of the American Society of Clinical Oncology in Atlanta, Ga.

Begun in June 2000, the phase III trial involved 1,106 subjects at 117 centers in 16 countries. Subjects were in CML's chronic phase, the most common stage of the disease, and had not previously received chemotherapy. Half were randomized to receive Gleevec and half to receive the standard treatment at the time the trial started, interferon-alpha and cytarabine arabinoside. Participants in the interferon arm were later allowed to cross over to Gleevec. Just 3 percent remain on interferon therapy.

"Prior to this, we had to project what the five-year survival data would be and worried that the risk of relapse might increase. With this data, we have increased confidence in this targeted therapy," Druker said.

At five years, the overall survival of the 553 subjects randomized to receive Gleevec as their initial therapy was 89 percent; 95 percent if only deaths related to CML are con

Contact: Rachel MacKnight
Oregon Health & Science University

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