New CML treatment provides survival benefits for patients with imatinib resistance
Patients with chronic myeloid leukaemia (CML) who are showing resistance to imatinib (Glivec) have improved progression-free survival when treated with dasatinib (Sprycel) compared with escalated doses of imatinib, according to data presented at a meeting of the American
Society of Hematology, held in Orlando, Florida, earlier this week.
The data formed part of dasatinib’s successful licence application;
the drug was launched as a treatment
for imatinib-resistant CML earlier
this month (PJ, 2 December, p659).
In the open label randomised Phase II study, 150 patients with chronic
phase CML with primary or acquired resistance to 400mg–600mg imatinib
were randomised to receive dasatinib 70mg twice daily (n=101) or imatinib
400mg twice daily (n=49). At 15 months follow up, the number of patients
achieving a major cytogenetic response was 53 per cent for dasatinib,
versus 33 per cent for imatinib (P=0.023).
The number achieving complete cytogenetic response was 40 per cent for
dasatinib versus 16 per cent for imatinib (P=0.004) and the number achieving
major molecular response was 16 per cent for dasatinib versus 4 per cent
for imatinib (P=0.038). Progression-free survival results show 6 per
cent of patients taking dasatinib progressed compared with 20 per cent
taking imatinib (P<0.0001; hazard ratio 0.14).
Similar side effects were observed in the two groups, although pleural
effusions were only seen in patients taking dasatinib.
Presenting the study, Neil Shah, from University of California, San Francisco,
said: “The overall risk benefit analysis favours dasatinib. Physicians
should consider treatment with dasatinib in patients resistant to lower
doses of imatinib.” |
The
Pharmaceutical Journal
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