The Pharmaceutical Journal
Vol 268 No 7199 p705-712
25 May 2002

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Imatinib should be considered for new chronic myeloid leukaemia patients

IMATINIB (Glivec) is better than current standard therapy as first-line treatment in chronic myeloid leukaemia (CML), according to trial data announced this week at the American Society of Clinical Oncology annual meeting in Orlando, Florida.

"Imatinib should now be considered the standard of care for newly diagnosed patients," says Professor Brian Druker, professor of medicine, Oregon Health and Science University, United States.

He reported the results of IRIS, a randomised trial comparing imatinib 400mg daily with an interferon/cytarabine combination in 1,106 patients from 16 countries.

"On every measure — response, tolerability and prevention of disease progression — imatinib was significantly superior," said Professor Druker. At median follow up of 14 months, complete cytogenetic response (disappearance of leukaemic cells) was seen in 68 per cent of imatinib patients and 7 per cent of interferon patients; 23 per cent of interferon patients discontinued treatment because of side effects compared with less than 1 per cent of imatinib patients. Disease progression to the accelerated phase or blast crisis was 1.5 per cent with imatinib and 7 per cent with interferon. "This is an astonishing result — I expected a 40 per cent complete response and we got nearly 70 per cent," Professor Druker commented.

Data on whether treatment leads to improved survival could be available by the end of the year. This will not allow comparison between the drugs, however, as almost all interferon patients have now swapped to imatinib.

Professor Druker says that the challenge now is to see if the IRIS results can be bettered. Combination therapy (imatinib with either interferon or cytarabine) will be tested to see if this prevents any development of resistance. Higher doses of imatinib will also be evaluated.

Commenting on the IRIS results, Dr Stephen MacKinnon, senior lecturer in haematology, University College London, said: "We need more information on the durability of response, but on the current evidence my view is that imatinib should be considered for all new patients." He acknowledged, however, that cost will be a major issue since the drug is unlikely to produce a cure and will presumably need to be taken long term.

Imatinib's manufacturer, Novartis, plans now to apply for a licence for first-line use in the chronic phase of CML (the current licence is for use when interferon has failed).

The IRIS data were not considered by NICE in its imatinib review (PJ, May 18, p675) as NICE only considers licensed indications, but it has been asked to look at imatinib again (see here). — Contributed.