SPRYCEL Advanced Phase Trial (140 mg)

Study Design

International, multicenter, randomised, open-label, phase III study in which 611 patients with imatinib-resistant or -intolerant advanced-phase chronic myeloid leukaemia (CML) were randomised to either the SPRYCEL 140 mg once daily or 70 mg twice daily group. Median duration of treatment was approximately 6 months.

Primary Objective: To estimate major haematologic response (MaHR) rates with QD and BID treatment.

Efficacy

• In patients with accelerated phase CML, median duration of MaHR was not reached for either group
  • Median PFS was 25 months for the 140 mg QD group and 26 months for the 70 mg BID group
  • Median OS was not reached for the 140 mg once daily group and 31 months for the BID group
• In patients with myeloid blast phase CML, median duration of MaHR was 8 months and 9 months for the QD and BID groups, respectively
  • Median PFS was 4 months for both groups
  • Median OS was 8 months for both groups
• In patients with lymphoid blast phase CML, median duration of MaHR was 5 months and 8 months for the QD and BID groups, respectively
  • Median PFS was 5 months for both groups
  • Median OS was 11 months for the 140 mg QD group and 9 months for the 70 mg BID group

PFS=Progression-free survival; OS=Overall survival.

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Safety

Significantly lower treatment-related side effects in advanced phase CML with SPRYCEL 140 mg QD than 70 mg BID

• Patients in the QD arm had significantly fewer pleural effusions vs those in the BID arm (all grades: 20% vs 39%, respectively, P < 0.001)