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Title: Patients on Imatinib Achieve Complete Response With Continued Treatment: Presented at ASH

"Patients on Imatinib Achieve Complete Response With Continued Treatment: Presented at ASH"

By Ric Susman ORLANDO, FL -- December 13, 2006 -- Patients with newly diagnosed chronic myeloid leukemia who do not achieve a complete response with imatinib (Gleevec) within 6 months may benefit from continued therapy and can achieve a complete response after 18 months of treatment, doctors said here at the American Society of Hematology 48[^th Annual Meeting and Exhibition (ASH).

Patients achieve major medical recovery at different rates, therefore, a lack of major medical recovery by 18 months may be too early to raise concern, explained Michele Baccarani, MD, professor of medicine, University of Bologna, Bologna, Italy, and a member of the IRIS (International Randomized Study of Interferon vs STI571).

He also suggested that "a medical recovery level alone should not trigger a change in therapy."

"A substantial portion of patients without complete cytogenetic response at 12 or 18 months eventually achieved these levels of response with continued imatinib therapy," Dr. Baccarani said in a poster presentation December 11^th.

Dr. Baccarani and colleagues evaluated 553 adults who had been diagnosed with chronic myeloid leukemia in chronic phase and were treated with imatinib. Of these, 509 patients remained on the medication for 12 months and 480 continued with treatment to the 18-month evaluation.

"Patients with metaphases between 1% and 35% at [either 12 months or 18 months] were considered to have reached partial cytogenetic response," he said.

Of the patients who had not experienced a major medical response at 12 months, 70% experienced a complete cytogenetic response. Of the patients who had not experienced a major response at 18 months, 50% had a complete cytogenetic response.

"Long-term efficacy outcomes are prolonged in patients who achieve complete cytogenetic recovery at 12 or 18 months," Dr. Baccarani said.

Patient progress was evaluated every 3 months after complete cytogenetic response. According to Dr. Baccarani "identification of patients who are more likely to be late responders or to benefit from imatinib dose escalation warrants further study."

This research was supported by Novartis Parma of East Hanover, New Jersey.

[Presentation title: Outcomes by Cytogenetic and Molecular Response at 12 and 18 Months of Imatinib in Patients With Newly Diagnosed Chronic Myeloid Leukemia (CML) in Chronic Phase (CP) in the IRIS Trial. Poster 2138]

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