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Once-Daily Dasatinib Remains Most Effective Dosing Schedule for Patients With Chronic Phase Chronic Myeloid Leukaemia: Presented at ASCO

By Walter Alexander

ORLANDO, Fla -- June 3, 2009 -- Three-year follow-up of the dasatinib dose optimisation study (CA180-034), in chronic phase chronic myeloid leukaemia (CML-CP), confirmed the approved dose of 100 mg once daily as having the most favourable long-term benefit-risk profile, and was presented here at the 45th Annual Meeting of the American Society of Clinical Oncology (ASCO).

The multicentre, open-label, phase 3 trial included patients who had resistance, suboptimal response, or intolerance with prior imatinib treatment.

Richard M. Stone, MD, Dana-Farber Cancer Institute, Boston, Massachusetts, presented the results in an oral presentation on June 2.

Participants were randomised to 1 of 4 treatment arms: dasatinib 100 mg QD (n = 167), 70 mg BID (n = 168), 140 mg QD (n = 167), or 50 mg BID (n = 168). The objective was to evaluate long-term efficacy and safety of once-daily dasatinib 100 mg, and to evaluate the predictive value of cytogenetic and molecular responses at 12 months.

At the 3-year follow-up, dasatinib 100 mg QD demonstrated efficacy, with progression-free survival of 73%, overall survival of 87%, and similar progression-free survival regardless of baseline BCR-ABL mutation status.

There were significantly fewer dose interruptions and reductions, and more dose escalations with 100 mg QD than with other dasatinib doses. Complete cytogenetic response rates with dasatinib 100 mg QD increased over time from 39% at 6 months, to 45% and 50% at 12 and 24 months.

Progression-free survival at 36 months was 73% for dasatinib 100 mg QD, compared with 67%/60%/72% for 70 mg BID/140 mg QD/50 mg BID, respectively. Overall survival was 87% for 100 mg QD and 80%/84%/84% for 70 mg BID/140 mg QD/50 mg BID, respectively.

Among patients with any baseline BCR-ABL mutation and resistance or suboptimal response to imatinib, progression-free survival was 66% for dasatinib 100 mg QD, as compared with 45% to 57% for the other doses.

Landmark analysis showed responses to dasatinib 100 QD at 12 months to be predictive of progression-free survival at 36 months. Those with major molecular or complete cytogenetic responses at 12 months had progression-free survival of 92% to 93%, as compared with 63% for those with other or no cytogenetic response.

Dr. Stone noted that dasatinib 100 mg QD was the best-tolerated dose, with few grade 3/4 side effects occurring between 24 and 36 months of follow-up.

"Dasatinib 100 mg once daily offers a more favourable long-term benefit risk profile in this population of CML-CP patients following resistance, suboptimal response, or intolerance to prior imatinib," he concluded.

[Presentation Title: Dasatinib Dose-Optimization Study in Chronic Phase Chronic Myeloid Leukemia (CML-CP): Three-Year Follow-Up With Dasatinib 100 mg Once Daily and Landmark Analysis of Cytogenetic Response and Progression-Free Survival. Abstract 7007]

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